JP2003515439A - Method and apparatus for controlling a strategy of formulating a pharmaceutical mixture - Google Patents

Abstract

A method and apparatus for controlling the compounding of pharmaceutical parenteral admixtures id disclosed. The apparatus preferably comprises a computer that contains a memory for storing instructions for operating the apparatus and for controlling compounders that prepare a prescription admixture, with the memory including data relating to a plurality of the pharmaceutical components that may be transferred to prepare the prescription admixture, and data concerning the operating characteristics of the compounders that the apparatus is adapted to control. The apparatus determines the order of admixing by general rules of admixing and by categorized compatibility groups of components, so that the number of rinses that must be done are minimized.

Description

Detailed Description of the Invention

The present invention relates generally to methods and devices for preparing and dispensing pharmaceutical mixtures. More particularly, the present invention relates to a strategy for preparing a formulation for parenteral mixtures and keeping track of the prepared mixture to control the compounding device, the strategy being implemented in computer software.

BACKGROUND OF THE INVENTION Parenteral pharmaceutical mixtures are combinations of sterile drugs that are mixed together under sterile conditions and are intended for intravenous infusion. These mixtures may be relatively simple or very complex, containing multiple active ingredients and increasing their complexity. A nutritional mixture is an example of a complex parenteral mixture that is frequently prepared at the hospital pharmacy to treat patients in the hospital. In general, parenteral nutrition mixture (“PN”) refers to most types of intravenous fluids. Total parenteral nutrition mixture (“TPN”) generally refers to PN that does not contain lipid as an ingredient, and total nutritional mixture (“TNA”) refers to PN that contains lipid.

The pharmacy of a hospital is a blending center or care facility that typically prepares or blends prescriptions determined by a physician alone or with a nutritionist, pharmacist, or other nursing staff. The pharmacy may need to be compounded with multiple PNs daily. The actual PN compounding is mainly done in an electromechanical mixing device called a compounder, but this compounder is very elaborate and, as shown in the pharmaceutical prescription, many in different proportions. It is adapted to mix different ingredients.

Compounders include high volume compounders, which are capable of relatively fast addition of components (eg, amino acids, sterile water, lipids and glucose) normally present in relatively high volumes in PN. It is adapted to prepare PN by transferring. Such a blender includes the Clintec Nutrition Division o
f AUTOX 3 + 3 compounder manufactured by Baxter Healthcare Corporation.

Compounders also include low volume compounders such as the compounders sold by the company as MICROMIX compounders. The MICROMIX compounder is adapted to accurately transfer the components normally present in the PN in relatively low volumes.

[0006] Typically, high volume ingredients are added to the final container or bag using an AUTOMIX compounder, and then the final bag is MI to transfer lower volume ingredients.
MICROMIX blender and AUT by transferring to CROMIX blender
It is common for pharmacists to generate a given PN by utilizing both OMIX compounders. It should be understood that a single compounder may be capable of transferring both high volume and low volume components either sequentially or simultaneously. Alternatively, this single compounder may have both high volume and low volume modules, which are common transfer tubes (which are connected to a common manifold, final bag or container) or separate Fluid can be transferred to the port, which is in the final bag.

In order to prepare such PN at an acceptable cost, it is important to blend PN as efficiently as possible. Efficiency is generally achieved by trying to maximize the number of PNs prepared over a period of time (ie, "throughput"). However, due to the complexity of correctly preparing PN,
Such processing capacity tends to decrease. Areas of complexity include determining the appropriate PN for a given prescription for a particular patient, accurately preparing this PN, and
Seen when accounting or billing. However, patient safety is a top priority, and efficient PN preparation must be achieved with little potential for error.

In preparing the correct prescription for a particular patient, the pharmacist must perform a number of tasks, including evaluating and determining the appropriate ingredients and their respective amounts. Patient-specific factors are considered (eg, patient type, ie, newborn, and patient weight). As the pharmacist's ability to make such assessments and decisions improves, so does its throughput and the likelihood of error. For the purpose of keeping records, it is desirable and sometimes necessary for the pharmacist to make a note of in a permanent record why the formulation differs from the generally desired amount of stock solution.

As is well known in the pharmaceutical industry, many of the complexities involved in preparing PN are related to the compatibilities associated with the components in a given PN.
) Problem. Compatibility means that a drug and all other ingredients with which it comes into contact (
It is defined as an interaction with (including, but not limited to, diluents, containers, and other agents in the same PN). Compatibility is divided into two subcategories, which are not only chemically compatible but also physical compatible. Physical compatibility is defined as an incompatibility that alters the physical appearance of the drug, resulting in a visual change such as precipitation, gas evolution or color change. Chemical incompatibilities are not visible visually and must be tested analytically. Chemical incompatibility occurs as a result of changes in the active drug, such as oxidation or photolysis. Factors that can affect compatibility include, but are not limited to, total diluent volume, concentration levels, mixing order and pH.

The evaluation of compatible and parenteral mixtures has two stages. First of all, the compatibility of total PN in the period between preparation of this mixture and completion of delivery to the patient should be evaluated prior to formulation. Second, the formulation process must be planned in a manner that allows for compatibility while the formulation process is in progress. For example, the compatibility between the stock solution added to the final mixing vessel or any intermediate mixing vessel and the solution present in that vessel should be evaluated. In many cases, stock solutions packaged at concentrations that are incompatible with other solutions must be diluted before being contacted with each other in such chambers.

As can be seen, maximum dilution occurs when a large amount of diluent is already present in the vessel into which these solutions are added. Stock solutions of amino acids or glucose, for example, account for the majority of PN, yet are typically compatible with most additives. Therefore, these solutions would first be transferred to this final container or any intermediate mixing chamber to dilute the added stock solution.

Another complexity that must be considered is the prevention of contact between highly concentrated solutions that are incompatible with each other along the common flow path of the compounder. In a typical case, the stock solution can flow along a separate tube with respect to most of the transfer channel, but there is a portion along the transfer channel common to the two incompatible stock solutions. obtain. This common flow path may be along any portion of the flow path, such as in the intermix chamber, or after the intermix chamber, or after the diverter valve.

One way to reduce the likelihood that a solution will become incompatible with a second solution along a common channel is to flush each common solution after transferring it. Such flushing is accomplished using a solution that is compatible with both the previous solution and the solution added after the flush. As can be seen, frequent flushing dilutes these incompatible solutions, making them compatible but also reducing throughput.

There must also be a fluid source for such a flushing plan. Such a flushing solution source can either be a compatible solution source that is part of the formulation or the solution that is present in the downstream chamber (eg, the mixture in the final mixing vessel). However, in current pharmaceutical practice, a given amount of solution used as a flushing solution is typically first transferred to this final container for convenience and dilution purposes and is not utilized as a flushing solution. In this case, by default, the solution in the final bag must be compatible with the flushing solution and the flushing solution is drawn from the final container. If the flash liquid is drawn out from this final container and returned to the final container, the throughput is lowered. On the other hand, if a certain amount of undiluted stock solution is pushed down for flushing, it is possible that the two incompatible solutions may come into contact with each other in this final mixing chamber without being properly diluted to compatible concentrations. .

For efficiency purposes, the pharmacist typically rinses components (which are set by the pharmacist) that are compatible with each other (at neat concentration) based on the operating plan of the blender.
Sort the solution containers so that they are added together sequentially between. After making a determination as to the compatibility of the various solutions, the pharmacist may classify one set of compatible solutions on stations 1-4, a second set of compatible solutions on stations 5-8, etc. ,
It is set after station 4, station 8, etc. However, a particular mixture may require five compatible solutions. Because setting up the rinse requires a long time and a lot of effort, the pharmacist may retain the fifth component at the station with the anterior and posterior rinses, rather than adjusting the arrangement and rinse regimen of this station. However, this is not optimal.

[0016] Another requirement that pharmacists consider when formulating multiple formulations containing a mixture of TNA and TPA is lipid clouding in the presence of trace amounts of lipid in the final solution, which should not contain lipid. is there. Haze can occur due to lipids present in amounts as low as 1-3 ppm. Such haze typically occurs when formulating a lipid-containing formulation immediately before a lipid-free formulation. Lipid haze is generally
Although not considered to be a health hazard, however, lipid haze in the infused PN can later be mistaken for an unacceptable formulation for PN resulting from errors in formulating compatible PN solutions. Yes, you may accidentally throw away a cloudy solution.

If lipid clouding is a problem, the pharmacist may seek to avoid such problems by compounding each formulation containing lipid and then flashing the compounder. However, such flushing is not completely effective because it reduces the throughput. To increase throughput, pharmacists can reduce such flushing by classifying lipid formulations, however, such classification has a negative impact on flexibility. If lipid clouding is not an issue, then the person who formulates this solution and administers PN to the patient should be informed that the lipid clouding may occur, and that the patient mistakenly believes that the mixture is not stable. You should prevent thinking.

Another way to try to prevent lipid clouding is to use a completely separate flow path for these lipids to the final mixing vessel. However, once the lipid is present in the final container, it is introduced into this channel by flushing or rinsing with a solution from this final container, causing lipid clouding at the next PN. Can cause.

In addition to the compounding complexity that pharmacists must consider, the precision limits of these compounders are such that formulations with ingredients at volume levels below the accuracy limits of this compounder will likely use syringes. Then it will be added by hand. Such manual addition reduces throughput. Also, the inevitable inefficiencies in administering PN to patients (eg, residual volume in the dosing set) must also be considered. Revealing these complexities has been found to be time consuming and cause inefficient work and operations.

For the purposes of reimbursement and record keeping, preparation mixtures generally achieved by reporting information communicated to the facility's accounting system, either manually or electronically, must be identified. The procedures the pharmacist must perform to ensure that a mixture is correctly grasped should be as low as possible to increase efficiency.

Therefore, a primary object of the present invention is to provide an improved method and apparatus for preparing and capturing parenteral nutritional solutions. Yet another object of the present invention is to provide a method and apparatus for preparing parenteral admixtures which are less likely to be incompatible, which is preferably demonstrated in various formulation admixtures. It involves implementing in software a method of adaptation to many known active ingredients and other ingredients. More specifically, a related objective is to prepare a formulation for parenteral mixtures, control its compounding device, and provide a strategy for correctly grasping the prepared mixture, which is implemented in computer software. It

Another main object of the invention is to provide such an improved method for preparing parenteral mixtures, mainly by increasing the throughput of the compounder by minimizing the number of rinses to be performed. To provide a device.

A related object of the present invention is to provide multiple formulations that may be present in these formulations in order to prepare the formulations more efficiently, eg, by maximizing the number of formulations that can be prepared over a set period of time. There is a provision that selectively determines the order and reordering of mixed solutions or compatible groups.

A more detailed object of the invention is to utilize the intermediate mixing chamber prior to transferring the contents of the intermediate mixing chamber (eg, funnel) for mixing the components to the final mixing chamber (eg, final bag). To provide an improved method and apparatus for controlling a blender.

Another object of the invention is the definition of patient-specific data to enhance the pharmacist's ability to efficiently formulate and safely formulate mixtures from formulations.

Yet another object of the present invention is to allow the pharmacist to efficiently compensate for the accuracy limitations of this compounder and the inefficiencies in administering PN (eg, fluid lost in the dosing set) to the patient. Another object of the present invention is to provide an improved method and apparatus.

Yet another object of the present invention is to include a concentrated formulation of components to replace a given formulation, but the diluent fluid may be supplied by other compatible components to minimize the volume of the resulting mixture. It is to provide an improved method and apparatus for determining whether or not.

Another object of the present invention is to provide such an improved method and apparatus for controlling this formulation to warn the user (such warnings should not be falsely ignored) when the recommended limits are not adhered to. To do. A related purpose is to provide input and recording of rationale for disabling warnings.

Another object of the invention is to reduce the possibility of lipid clouding and the possibility of accidentally mistakenly forcing such cloud to be an improper precipitate or to alert the user to those possibilities. To provide a device.

These and other objects will become apparent to those of ordinary skill in the art by reading the following detailed description, with reference to the accompanying drawings.

DETAILED DESCRIPTION Broadly speaking, the present invention relates to a method and apparatus for controlling the formulation of a pharmaceutical mixture, where the formulation is performed by one or more compounders. , Remote to a controller computer or processing means in communication with these compounders. Referring to FIG. 1, the controller computer or controller 10 has sufficient memory to store pharmaceutical data in the form of a database, as well as operating software used in controlling the compounder and other peripherals. Have. The computer 10 is preferably a multi-user, multi-tasking computer, which may be a communication line 22 (which may be wired or wireless and may be a local area network, a wide area network or the Internet or a combination of the above). Can be) by the compounding machine 12, 14
And 16 and other peripherals (eg, printers 18 and 20) have communication interfaces. The computer 10 may have a display 23 and a keyboard 25, as well as other accessories and features common to current commercial computers.

Other peripherals include keyboards and displays (eg, laptop computer 26) or other input devices or other manual devices (which enter prescriptions and operate software on the controller computer). A dam terminal 24, which is adapted to enter commands). These blenders may be installed in different areas of a healthcare facility (eg, hospital), or on different floors of a hospital or even in different hospitals. The printer 18 and terminal 24, as well as the blenders 12 and 14, may be installed in Hospital B in FIG. 1, while the rest of the equipment is shown installed in Hospital A. Preferably, as shown, a printer is installed near the compounder or combination of compounders to print the labels on the formula mixture to be compounded. The controller computer 10 preferably interacts with a general purpose hospital computer 28, which may be used, among other things, to create and record bill specifications.

The present invention is adapted to control compounders such as compounders 12, 14 and 16. Having two machines at Hospital B means that in order to prepare the prescription mixture,
Two different types of compounders (eg, as an example, the AUTOMIX and MI
CROMIX compounder) can be used in combination. therefore,
The blender 12 may be a blender for transfer of high volume additives, and the blender 14
Can be a compounder for low volume additives. Further, the compounder 16 can be adapted to transfer both high and low volume components.

Referring to FIG. 2, a perspective view of a low flow rate module compounder is shown, which illustrates low volume components (eg, micronutrients and other agents) from individual source vessels 30.
Is adapted to move. However, the formulation mixture may be prepared by a single compounder 16 adapted to move high and low volume additives, or by multiple compounders mounted in a single final bag 46.

In one embodiment, when high accuracy is desired, for example when low volume additives are being added to the PN, the fluid from the container 30 may be passed through a separate and independent fluid conduit 32 into a single fluid conduit 32. To an intermediate container or funnel 34, which is suspended from the local cell assembly 36. The local cell assembly 36 weighs the total weight of the funnel 34 and produces an output signal, which is indicative of the amount of fluid in the funnel 36 at any given time. The funnel 34 is closed and connected to a pressure conduit 38, which according to the example is connected to pressure and closure means (eg valve 40). This pressure means is preferably a single peristaltic pump, which can selectively create positive and negative pressures in the funnel 34 to control the flow rate and direction of fluid to and from the funnel 34. The funnel 34 is also connected to an external conduit 42, which extends to a second closure means 44, which is sandwiched between the funnel 34 and a final bag or container 46. By selectively operating the closure means 40 and 44 and the pressure means, fluid is drawn into this funnel and
Moved from there. The same part of the machine can also control the flow direction so that the fluid can move to the final bag 46 and for the purpose of rinsing the funnel 34,
It can be removed from this final bag.

The detailed operation of an example of a compounder adapted to move low volume components, at least as of about April 1990, is described in US Pat. No. 5,228,485, which describes the present invention. To the same assignee, the contents of which are incorporated herein by reference. Current commercially available MICROMIX compounders may include certain improvements over the '485 patent, but are believed to be similar to those described in this patent.

The compounder 12 also includes an assembly that alone or in combination with the volumetric delivery method utilizes one or more other pumping and other operating methods such as switching mechanisms to move the additive. Yes, this is probably BAXA Corporation
Included is a calibration such as a compounding device marketed by ation of Anglewood, Colorado.

Referring to FIG. 3, yet another embodiment of compounder 50 is depicted, which is particularly suitable for transferring high capacity additives. The compounder 50 includes a number of independent pumping stations 52, which cooperate with a disposable transfer set 54 to pump fluid from individual source containers 56 to a final container 58. Detailed operation of an example of a compounder adapted to move low volume components, at least approximately 1999, is described in U.S. Pat. Nos. 4,712,590 and 5,927,349, which are incorporated herein by reference. To the same assignee, the contents of which are incorporated herein by reference). Currently commercially available AUTOMIX compounders may include certain improvements over the '485 and' 349 patents,
It is believed to be similar to that described in this patent.

Formulation Preparation In one example of a method utilizing the preferred embodiments of the present invention, a physician or other health care provider or group of providers will determine what is needed for a patient's parenteral nutrition. Determine and prescribe. The pharmacist then needs to convert this formulation into a specific amount or concentration of additive in the PN to be administered to the patient. These amounts will vary depending on the particular patient. For example, a patient may not accept large amounts of fluid parenterally, and nutritional requirements are needed to achieve within the lowest possible volume of fluid. One example of a fluid-constrained patient is a neonatal patient. To administer the desired amount of additive in a smaller total volume, the concentration level of additive in the final bag 46 can be higher in PN than if more diluent volume could be used. This high concentration can likely cause compatibility problems with other additives in the PN and can exceed patient acceptable limits.

Referring to FIG. 3 a, in the preferred embodiment, the pharmacist uses the keyboard 25 to enter patient identification data (eg, patient ID code) into the controller (block 70). Controller 10 then requests and receives patient-specific data from the facility's data storage location (eg, computer system 28) (block 72) and displays such information on display 23. One form of patient-specific data that is preferably used by controller 10 in the preferred embodiment is the type of patient (eg, premature, newborn, pediatric or adult, etc.). In an alternative embodiment, the provider enters the patient-specific data directly into the controller 10 or a storage location therein.

The controller 10 also maintains a preferred range for acceptable concentration levels of different mixtures in the final bag 46 in the storage position. In one embodiment, the controller 10
The data storage location may also hold component concentration ranges for different patient types to set preferred concentration ranges, as well as type dependent ranges for particular patient types. In yet another embodiment, the data storage location may hold ranges corresponding to patient attributes (eg, age and weight of various patients),
The control device 10 can set a preferable density range together with the attribute specifying range.

In yet another embodiment, the controller may also include an algorithm that adjusts this concentration range based on certain patient-specific factors such as the age of the patient.

Therefore, based on this patient-specific data, controller 10 may evaluate whether these preferred ranges are appropriate for the patient-specific type and then adjust this range (block 74). .

The healthcare provider then enters the prescription (block 76), for example, by using the keyboard 25. Upon entering the prescription, the provider sets the concentration level of its component solutions such that the PN corresponds to the prescription during compounding. The controller 10 allows this prescription to be entered in several different formats. By way of example, the controller 10 may receive inputs of these components as a percentage in its final solution (concentration per unit volume or amount corresponding to a unit weight of the patient).

As the provider enters the prescription, controller 10 checks the input concentration against the determined range (block 78). If a concentration outside this range is entered, an error message will be displayed on the display 23. In addition, if the provider enters an ingredient in an improper format, the display will display an error or warning message to alert the healthcare provider. One example of an inappropriate format is when this concentration is entered in a unit of measure per patient weight, but the patient weight was not entered as part of the patient-specific data.

In an alternative embodiment, after entering all concentrations, controller 10 may then review the various components and highlight those components outside the range set for that component with an error message. .

In yet another embodiment, in the storage location, templates of different prescriptions corresponding to different types of patients can be retained. Then the pharmacist or controller 10
May call this template to accept or adjust the template. In yet another embodiment, the patient's previous prescription may be retained in the storage position. The pharmacist or controller 10 may then recall the previous prescription and adjust or accept the previous prescription for use as the present prescription.

When the alert is displayed, even if the concentration is out of range, this concentration may still be desirable at the medical judgment of the provider. The controller 10 may then allow the provider to disable the alert in certain predetermined cases (
Block 82). The controller 10 allows invalidation when one or a combination of certain factors occurs. One factor is whether the provider entering this prescription has clearance to override a particular alert. Each alert may require a different level of clearance before allowing this nullification. Some alerts cannot be disabled.

The identity and clearance level of this provider can be established by the unique password required by the controller 10 and can be entered at the appropriate time (eg, at the start of entry of the prescription or at the appearance of an alarm). (Block 84). Other methods of establishing this donor identity (eg, keywords, retinal scans, etc.) are also considered.

In addition to establishing this provider clearance, it is verified that the provider recognizes and understands the error message for the purpose of recording. The controller 10 may request that the rationale for this defeating be entered into the note screen displayed on the display 23. In some alarm situations, the controller 10
Even with rationale, it does not allow any invalidation (block 86).

Compatibility Class A preferred embodiment of the present invention is that the compatibility of these components and the solutions they contact during the compounding process, as well as the solution in the final solution bag 46 after this compounding is complete. Evaluate.

In current practice, evaluation of final prepared PN is a process that pharmacists routinely perform. The pharmacist compares the ingredients of the final prepared mixture with the literature, which contains information related to compatibility. In many cases, this document is not sufficiently specific for the exact type of ingredients in this mixture to be prepared, and pharmacists will not be specialized in deciding whether the resulting mixture is compatible. Need to use good judgment.

In accordance with the present invention, the overall compatibility assessment for complex mixtures focuses primarily on parenteral nutrition formulation, which broadly includes PN screening and calcium phosphate solubility screening.

The process preferably includes a first screening step that compares the total PN additive to the limits set in the controller 10, which, as mentioned above, sets the preferred concentration limits. Can be included.

The second step involves comparing the final concentrations of amino acid, glucose and lipid-based components to the database of tested mixtures. Amino acid comparisons are brand specific. The mixture database has been adapted by testing the mixture and by utilizing published literature. The mixture database preferably contains concentrations for both stable and unstable mixtures, along with notes on study conditions such as time and temperature. The preferred database is
It includes a mixture having identified ingredient components (eg, brand name amino acids).

In the second step, the given mixture is compared to a database of mixtures. Preferably, this comparison is first performed on the mixture with the identified raw material components.
If a given mixture falls within a range of stable mixtures, the present invention proceeds to the next step without notifying the pharmacist. This range can be set by a certain amount of variation, for example, by the amount of the corresponding base component in the stable mixture or the set percentage of the concentration level.

However, a mixture that is consistent with the unstable formulation contained in this database (preferably a set variation of the base component amount of ±) (or a mixture of stable and unstable) is still the first. It has not passed the screening process, but may be referred to as potentially stable.

In one embodiment of the invention, if this predetermined mixture matches an unstable mixture, further steps (eg, the matched mixture study conditions are equivalent to those of the present invention). Whether or not the step of screening) can be performed. The present invention is
It warns the pharmacist that this mixture is equivalent to a potentially unstable mixture under the study conditions.

In yet another embodiment, a mixture that does not match any stable or unstable mixture contained in this database is reevaluated. When this is done, the amino acid brand is ignored and the mixture is then compared to the entire database. This comparison result is processed following the same steps previously described. Preferably, the pharmacist is warned about ignoring the amino acid brand of this database mixture. If this mixture is re-evaluated of the whole database,
If it does not match this database, the present invention alerts the pharmacist that a similar PN has not been previously tested.

For calcium phosphate solubility screening, the solubility of calcium salts and phosphates in the same solution depends on a number of variables including concentration, temperature, salt shape, mixing order, pH, amino acid concentration, Other additives and times include, but are not limited to. It is practiced in the art that pharmacists compare the final concentration of both this calcium salt and phosphate to the solubility curve specific for a given amino acid brand and final concentration.

In the present invention, calcium phosphate solubility screening in a complex formulation process is accomplished by the controller 10 comparing the final concentration of both the calcium salt and the phosphate with a matrix of known compatibility. This matrix can be entered by the pharmacist in a storage location or pre-populated in the database. The present invention uses this matrix to sort compatibility by this amino acid brand and final concentration. For example, a calcium phosphate solubility matrix for a particular amino acid brand may have compatible concentrations of calcium salt and phosphate for final amino acid concentrations of 1%, 2% and 4%. The present invention determines the solubility limit and, if exceeded, alerts the pharmacist.

In yet another embodiment, the controller 10 may create and display a graph on the display 25 of a shape depicting the calcium phosphate solubility for a particular amino acid, or the pharmacist may obtain a compatible prescription. In order to aid the solubility profile, a name for a given mixture may be provided for the solubility profile.

However, in addition to determining if the formulations present in the final bag are compatible, the compatibility during the compounding process must be evaluated. For example, the compatibility of one solution with the second solution at the time of contact must be evaluated. The second fluid may be in the common conduit, the intermediate mixing chamber or the final bag. To overcome this potential problem, pharmacists may adopt holistic rules for this compounding process. For example, first add the total diluent volume to this final bag so that all additives present in this final bag are diluted as much as possible at the time of the addition of the additional ingredients to the final bag. Is generally practiced. However, doing so reduces the ability to rinse with such diluents during the compounding process.

In accordance with an important aspect of the present invention, controller computer 10 may utilize the known compatibility of ingredients to allow such compatible ingredients to be simultaneously compounded into the final bag or intermediate mixing chamber. . In addition, rinsing can be accomplished using a stock solution, which is compatible with both solutions flowing through the rinsed part before and after the rinse. Therefore, the large volume additive may be transferred to this final container or bag at the same time as the small volume additive, or may be transferred to the intermediate mixing chamber, or used as a rinse fluid. Such compatibility screening and co-blending allows the present invention to maximize the rate at which the blend is blended, resulting in more efficient use of these blenders as well as this controller computer.

In accordance with an important aspect of the present invention, testing components for compatibility properties is used to build a database containing multiple groups, which is based on testing the components concentration dependent compatibility. Represents As an example, there are seven groups of components identified in Table 1 below, based on current knowledge. To the extent that one group is created for each individual ingredient, or even separate groups of different concentrations for the same ingredient, as more and more information is obtained about the compatibility properties of the various ingredients, more groups of ingredients are defined. It should be understood that this can be done.

[0066]

[Table 1]

These compatible groups can be identified based on test results and included in the controller computer so that the compounding process can be performed using the information in the database. This database is distributed at various locations so that it can be reliably controlled, managed, and modified as additional knowledge and information is gained through history, serial testing, and the addition of other drugs and ingredients to the database. Rather, it is preferably installed only on this controller computer.

In a preferred embodiment of the present invention, based on this database, the controller controls the raw material container 30 (FIG. 2) regardless of the physical arrangement of one of the compounders 12, 14 and 16. The fluids in) are logically classified into their compatible groups.

In yet another embodiment of the present invention, the controller provides, for a particular formulation, the number of groups present and the compatible group set of those groups between which the total number of rinses is minimized. Rinsing is required).

In yet another embodiment of the invention, the controller uses its correct formulation procedure to more efficiently utilize the stock solution as a rinse, as opposed to the rinse from its final bag. It makes use of other inputs such as the physical constraints of the system to make the decision. Examples of physical constraints may include the volume of the intermediate chamber or funnel 34 and the volume of rinse liquid in such chamber.

In one example, this intermediate chamber has a funnel with a volume requirement of 60 ml and a rinse liquid volume requirement of 30 ml. If this prescription is 5ml, 1 group, 20m
If 2 groups of 1, 2 groups of 20 ml, 4 groups of 55 ml and 6 groups of 40 ml are required, the control device 10 controls the combination of groups 1, 2, 3, 6, and 4 instead of the ascending order procedure. The order may be adopted.

Partially filling the funnel 34 with Groups 1, 2, 3, and 6 (10 ml) only then draining the partially filled funnel before adding the rest of Group 6. By doing so, at least 30 ml of the fluid of group 6 remains after the funnel 34 is first filled, and this fluid of group 6 can act as a rinse liquid, thereby requiring the rinse from this final bag. Disappears.

Other examples of sorting relationships or algorithms may be defined and implemented in this controller to achieve user desires (eg, to minimize the number of chamber or funnel 34 drains, a group of Assigning the capacity of to other compatible groups,
Can be made as little as possible).

To reiterate this, in this regard, it is expected that in Table 1, although seven distinct groups are included, yet another group is defined, which are:
It may be based on more sophisticated knowledge and tests. The exact number of groups is ultimately a function of the complexity of the compatibility findings for all other components used, and it is believed that a very large number of groups are defined.

This allows the controller computer to more accurately control the blending process which results in higher blending efficiency and speed. In addition, this database can be considered proprietary as its sophistication increases, and controlling this database in one place provides important protection (if this database is, for example, each blender). This protection does not exist if distributed to processors located at.

Formulation Strategy In yet another embodiment of the present invention, a mixing strategy or method that recognizes the potential for clouding of a liquid and utilizes as little rinse as possible from its final bag is shown in FIG. 4b. ˜4 h, which illustrate a preferred embodiment of the method of defining the operation of at least one compounder for feeding the nutritional formula mixture. The start of the method or process (block 100) is shown in Figure 4b, which occurs after the prescription enters the controller computer.

In an alternative embodiment of the invention, the formulation is first screened by controller 10 in one or more of the above methods.

The next step is to determine the compounding strategy (block 102), which depends in part on the type of compounding equipment present.

In this regard, as mentioned above, a hospital, other medical facility or pharmacy
It may only have a high flow rate module compounder 12 (FIG. 1), which is adapted to move high volumes of fluid at relatively high flow rates. However, if the facility also has a low flow module blender 12, it can move the solution at a low flow rate, which generally allows for the addition of very small or few components to the bag. Thus, if a specially selected high volume and low volume blender is used, the blender determines a blending strategy (block 102) and determines which strategy to use. This program can either be high flow rate (block 104) (which controls, for example, a high flow rate module compounder), low flow rate (block 106) (which controls, for example, a low flow rate module compounder), or high. To control either the flow rate or the low flow rate (block 108), which results in both machinery used in a single compounder 16 suitable for both high volume transfer and low volume transfer, for example. Has been adapted to.

First of all, referring only to this high flow rate, the controller determines that the high flow rate only compounder setting (block 104) (this is for each high volume component that is part of this final bag, Perform the initial blender calculations for (including several calculations that perform this program). This includes specific gravity-based calculations to convert the volume index into a weight index, where this transfer is performed by using the weight transferred rather than the component volume transferred. In this regard, if these compounders move based on the perceived weight of the components being moved, the formulation may be written using the measurements entered in grams, milliliters or percent of its final solution, and The software may need to convert these measurements into weight. For example, the high flow rate module blender 14 and the low flow rate module blender 12 utilize the weight or weight change of the intermediate or final container to blend.

After performing these calculations, line 110 extends to FIG. 4c, where it is determined whether the lipid-containing formulation should first transfer these lipids to this final bag. A decision is made (block 112), which is a user setting. In this regard, the user may want to put these lipids in this final bag first or last, which is strictly a user-specified option. Such designations are preferably based on criteria initially set prior to operating these compounders at the facility.

This involves sorting all of these additives into compatible groups, which is done by grouping the common compatible components as shown in Table 1 above. In this final bag, if the lipids are first transferred, the compatible meta group (m
The number of eta-groups) is determined, and the number of rinses required, N (block 114), is determined, and then the program first uses lipids to specify the procedure for bulk transfer. Once this procedure is determined, line 118
4d extends to FIG. 4d, where a command to operate the blender is communicated to the blender (block 120).

Alternatively, the controller 10 can utilize other user settings, including settings that reflect the general rules for mixed TPN, to move the fluid (block 11).
6, 124). Regarding the general rules for mixing all parenteral nutrients, they include: Phosphate is added before the calcium salt.

2. A determination of the solubility of calcium phosphates should be made based on the volume of solution in this TNP bag at the time the calcium is added.

3. Calcium should always be the last additive to this TPN bag if lipids are not required as the last additive, and will survive a single rinse if possible.

4. Compatible groups are numbered sequentially to match the mixing order unless specific exceptions are made.

If the blender 14 has a separate conduit to the final bag for each of its stock solutions, the controller 10 will ensure that this fluid has been added to the final bag.
Sets the pumping order and the main determinant of this pumping order is the compatibility of the fluid entering the bag with the fluid present in the bag.

Referring to FIG. 4c, when these lipids are not present in this final bag,
As with the number of rinses required, the number of compatible groups is also determined (block 122),
And the lipid-terminated transfer and rinse procedure is determined using one or more of the compounding methods to be performed, and the final step, indicated by line 126 (which extends to FIG. 4d), is this compounding. Give a move command to be sent to the machine (block 120)
.

Turning now to this low flow rate only path (which begins with the initial formulation calculation for low flow rate only) (block 106), this is accomplished using, for example, a low flow rate modular compounder. Used to formulate the mixture formulation to be performed. Even though there may be a high flow rate compounder in the same area, the volume intended to be added to this final bag is relatively small (eg for neonatal delivery prescriptions or very low infusions). In contrast, it is common to choose this low flow blender.

An initial determination is made whether this final bag already contains lipid (block 130). The reason for making this determination is that a large volume of fluid component may already be transferred to the bag and there may be a formulation that is compounded in two stages, and this bag is then placed in a low flow rate module that transfers micronutrients. Have been done. If lipids were already present in this bag, it would have an effect as to how the rinse from this final bag would enter the funnel or intermediate mixing chamber that may be present in the low flow rate module compounder. Exert.

The program determines from this formulation whether lipid is present in the bag and, if present, the entire mixture formulation is examined to determine whether it is present in this final bag or in the future. Determine if it exists If they currently exist, this question is asked as to whether the user cares if there is a lipid cloud in the next mixture formulation (block 132). This is due to the fact that some of these lipids will remain in the funnel if any rinse is performed using the fluid from this final bag. These lipids can be transferred to multiple subsequent bags in an amount sufficient to cause visible clouding in the solution. If the current bag has lipids, the next one has no lipids, and the surfaces that come in contact with the contents of both bags are not rinsed (especially the previous bag uses rinse solution from the final bag). If so, these lipids can cloud the next bag. If the facility does not desire lipid clouding, the compound will not be prepared at that time and will remain in the queue to be compounded at other times (block 134). If the hospital allows lipid fogging, a warning is printed on the printer (or visual display) to indicate that there may be lipid fogging on this funnel (block 136).

If the final bag contains no lipids (block 130), or if they contain lipids but do not mind lipid haze (block 136), use this solubility and compatibility table, and Keeping in mind that the rinse is obtained from this final bag, continue to calculate this compound (block 138). This step is aimed at performing calculations designed to minimize the number of rinses and maximize efficiency, and may utilize one of the above methods. When this is done, the line 140 extends to Figure 4d, and the move command to the compounder is then sent to the compounder (block 142).

Turning now to the high and low flow rate branches shown in FIG. 4b, the initial step was to set up the compound setup (which is the conversion calculation described for the high flow rate only operation (block 104)). To start (which needs to be done) (block 1
08), line 144 extends to FIG. 4c, where the number of compatible groups and the number of rinses are determined (block 146). Basically, it is a decision as to whether there is a problem with the formulation if it is formulated in a written manner.

This determination is made as to whether there is lipid in the final bag (block 152). If lipids are needed, this determination is made whether the lipids are initially or lastly migrated or otherwise optimized (block 154). Whether the lipid is at the beginning or end or optimized is a user preference, which is programmed in the sense that once the user defines it, it is then formulation independent. Optimization always means that the lipids are placed first. Therefore, the formulation criteria established by the user first determine the process path to select. If they are initially or optimized, the lines 156 extend into FIGS. 4d and 4c and enter the process described below. If there is no lipid in the final bag, line 158 is shown in FIG.
Extending to d and 4e, this also enters the process described below. If lipid is finally needed, line 160 extends to FIG. 4d and a determination is made whether this formulation is stable without lipid volume (block 162).

If the prescription is not stable without the lipid volume, the program alerts the user that the prescription cannot be combined at the end of the lipid and may require pharmacist testing (block 164). ). The program then first determines if lipids can migrate to the final bag (block 166), else the compound is not prepared (block 168). If these lipids can be transferred first, line 170 extends to FIG. 4e, where the number of rinses, including the lipid volume, is calculated and the lipids are first transferred to this final bag (block 172). .

Returning to block 162, if the formulation is stable without the lipid volume, the program calculates all solubilities, including the lipid volume, and the lipid is finally added to this final volume. It is moved to the bag (block 174) (Fig. 4d). A lipid volume free solubility calculation (block 174) is performed to calculate the calcium phosphate solubility based on a volume that is probably less than that contained in the initial screen. So, for example, if the total volume P of 200 ml
Given the presence of 50 milliliters of lipid in N, this calcium phosphate solubility assessment is made based on 150 milliliters.

After rinsing was calculated after this compatibility classification (blocks 172 and 174),
The program then determines if the total volume excluding lipid is greater than the funnel volume (block 176). If yes (more) then line 178
Extending to FIG. 4f, where the program determines whether lipids are initially present (
If yes (first), block 180), a program is obtained to determine if the base feed rinse rinse times can be retained for the rinse in an acceptable procedure (block 182). If so, the program enters the compatible group and blends with the required rinse from the selected source vessel proceed (block 184), and the directives call this blend. To the machine (block 186). Blocks 182 and 1 as described above
Although the steps described at 84 are recognized as separate steps in this flowchart, they are actually interrelated. The reason for this is that the number of rinses is a function of the compatibility group, which must be determined to identify where the rinse should occur, as described above.

If the total lipid-free volume is less than or equal to the funnel volume, completion of the compounding is done using the low flow rate module and done in the funnel of the low flow rate module compounder. You can This program determines if the source rinse volume of the component solution can be reserved for the final rinse (block 1).
88), if possible, in this funnel, the raw rinse volume of the base and all other ingredients is blended and transferred to this final bag, which funnel is then rinsed with its preliminary base (block 190) ( The rinse is moved to the final bag) and when a transfer command is sent to the compounder (block 19).
2), withholding will occur.

To determine if the raw rinse volume can be withdrawn, the fluid present during mixing in the funnel can be screened to some extent without dilution effects of the rinse. It is necessary to check whether or not (that is, whether or not the obtained mixture is stable). Also, the performance of this funnel is important with respect to the volume that it can withstand to provide a complete rinse. For example, if the funnel's performance is 50 milliliters, and only 30 milliliters can be reserved, then there is not enough funnel rinse and a decision as to whether this is sufficient can be made by the user. This rinse method uses the final rinse as a raw material component (
Care should be taken to originate from, for example, sterile water, glucose or amino acids, and a solution from the final bag may be used to perform an intermediate rinse (the ingredient volume of the raw rinse is such that this funnel is as clean as possible). As withheld for that final rinse) is also considered.

If there is not sufficient source rinse capacity, then the program determines if any amount of this source rinse capacity can be reserved for the final rinse (block 194) and if so, (Reserved) and in this funnel all other ingredients are blended and rinsed on this preliminary base (block 196). These move commands are then sent to the compounder (block 198).

If there is not enough raw material in the final rinse, then all ingredients are compounded into the funnel without any rinse (block 200) and a command is sent to the compounder. (Block 202).

From block 152, if the answer is that there is no lipid in this final bag, assuming that its total volume exceeds the funnel volume, then the lipids are first block 180 from the path through this flow chart. It should be understood that it is not applicable in practice, since lipids are not present. In this case, steps 182 and 184 may be performed, with the raw rinse liquid coming from the raw container and / or the final bag. As mentioned above, the controller preferably utilizes a rinse and compounding procedure that eliminates the need for rinses from the final bag.

Returning to block 204, if the answer is no, ie if the mixture contains lipids then those lipids should first be transferred and rinsed from the final bag. Is needed (block 182), the program determines if lipids can be finally translocated (block 206), and if not, the program asks if lipid clouding is acceptable ( Block 20
8) If not, then this compounding is not continued (block 201). if,
If it is acceptable, this program will issue a warning about lipid clouding (
Block 212).

If these lipids are able to migrate last, then the program determines whether the rinse rate of this raw rinse can be retained for the rinse and a single rinse from this final bag. It is determined whether the possible procedure can be performed (block 214). If possible, the formulation is analyzed for compatibility groups, compounding proceeds, these rinses occur at the appropriate time, and preferably the next rinse after the last rinse is derived from this ingredient. (Block 216) with all ingredients of the final bag. In this way, rinsing with the contents of this final bag will dilute the components present in the final bag as much as possible while still allowing a final raw material container rinse. These commands are communicated to the blender (block 218).

If the answer from block 214 is no, then line 220 (this is
(Extended to FIG. 4g) is the number of rinses-2 times (N-2), and a program for determining whether or not this raw material component rinse liquid can be retained for the rinse in an acceptable procedure is obtained. Two rinses from the final bag are determined (block 221)
. If yes, the compatible group step is performed again (block 224).
A command is issued to these compounders (block 226). If no, then another decision is made (block 228) at rinsing times-3 (N-3), a compatibility analysis is made, and if yes (block 230), a move command is given to this compounder. Is sent (block 232). If no, this decision is made for N-4 (block 234). If the determination from block 234 is yes, then the compatibility analysis is performed again (block 236) and these commands are communicated to the compounder (block 238). If the determination at line 240 is no, the program then determines if the source rinse can be retained for the final rinse (block 242) and, if yes, once again this compatibility analysis. Are executed (block 244) and these compounding instructions are issued (block 24).
6).

If no, the program determines whether an arbitrary amount of stock solution can be withdrawn to reduce the required lipid-free volume below the funnel volume (block 248). If the answer is yes, then the appropriate volume is withheld, the ingredients are blended in the funnel, and the retained base ingredient is used to rinse the funnel (block 250). , Their move commands are issued to this compounder (block 252). If not, the program determines if lipid is present in the formulation (block 254) and, if not, a program to formulate all rinses from this final bag. Obtained (block 256), these commands are issued to the compounder (block 258), but if lipid is present, the program returns
It is determined whether lipid cloudiness is a concern (block 258). If you don't care, give a warning (block 260); if you care, the compound is not prepared (block 262). After issuing this warning, the compounding proceeds with all rinse from the final bag (block 256), resulting in a move command to the compounder (block 258).

In sending these commands to the compounder (blocks 192, 186, etc.), the compounder and controller may utilize several methods and adaptations to perform the compound. For example, the controller 10 may send commands to a controller included as part of the compounder 12, 14, 16 or the controller may directly implement the compounder or any combination or similar method. Can be operated.

In addition to the formulation strategy implemented in the manner described in connection with the flow charts of Figures 4a-4h, there are other functionalities implemented by the present invention. In this regard, the controller computer 10 checks each formulation mixture for the composition present in the queue of such formulation mixtures (that command is issued to the compounding machine that prepares the mixture). Is adapted to. By examining the components of each formulation mixture in this queue to determine the lipid-containing mixture, for example, the lipid-containing mixture is treated with lipid until the final portion of the lipid-containing mixture is prepared. Both can be sorted in order so that cloudiness is not a problem.

As described in US Pat. No. 4,653,010, the formulation mixture present in the queue can be sorted and sorted around the customary ingredients. 1 of the present invention
In embodiments, other desired classifications of the mixture (eg, depending on patient type) can be determined in a similar fashion. Such reordering of the formulation mixture in this queue can be effective in increasing its throughput due to the needs and requirements of the facility.

Another important aspect of the present invention is to increase the volume of each of the ingredients to be added to the formulation mixture by a predetermined amount to obtain a mixture of equal formulation but slightly larger volume, This formulation is very much responsible for the ability of the computer 10 to adjust for the user-defined overpacking volume so that the exact amount of this ingredient is actually delivered to the patient in the desired concentration. When low concentrations of the mixture are required, an administrator set is prepared or the volume that needs to be considered for accuracy issues is compensated.

Yet another important aspect of the present invention involves the ability of the computer 10 to accept user switchable options upon activation of which the diluted high concentration component replaces the predetermined low concentration component. Can be used for. In many cases where the patient is fluid-free, diluting a concentrated solution with a compatible rinse (eg sterile water) produces a given mixture with as little potential instability as possible. In a further embodiment of the invention, the stability of this mixture is reduced, especially when the patient is fluid constrained, in eliminating or minimizing diluent by considering other components as a diluent fluid. , Determined by controller 10, which may use one of the methods described above to determine stability during or after compounding.

In yet another embodiment of the method of the present invention, a compounding strategy for overfilling the final bag 46 may be implemented. As mentioned above, overpacking may be desired to compensate for the amount of mixture, but this cannot be managed by a management system. For example, a portion of this solution may be retained in the final bag even after administration.

In keeping with one aspect of the invention, the desired method of setting this overfill can be specifically configured. By way of example, the overfill capacity can be set by percentage or in absolute quantity such that the final bag has a particular desired quantity. In preparing such formulations, the method calculates the novel amount of ingredients needed to obtain a mixture that is substantially equivalent to the given mixture but slightly larger in volume.

In determining the correct amount of this ingredient, the controller 10 examines the resulting mixture against various criteria to determine if the resulting mixture can be administered. . For example, for fluid-constrained patients, over-packing can result in a mixture with an excess of fluid over what is allowed. A warning may be issued to the user and an error message may be displayed.

In yet another embodiment, the controller 10 controls the controller 10 to provide one or more of these components at a predetermined level (eg, the minimum precision amount proposed for the compounders 12, 14, 16 (min.
A volume adjustment of this mixture may be made or suggested in order to avoid being present in an amount less than the level corresponding to the immune accuracy amount). As an example, the amount of an ingredient may be 90% of the minimum suggested amount. The controller may then increase the total volume of the mixture so that the amount of this ingredient reaches the minimum suggested amount, and for the user only a portion of the resulting mixture should be administered to the patient. Instruct.

It should be understood that the sequence of steps in various preferred embodiments of the present invention may vary. For example, the stability of the final mixture can be determined before and after the determination of the correct formulation strategy.

(Reporting) The compounding machines 12, 14, and 16 are controlled by the controller 1 during and after this compounding process.
You can contact 0. For example, a sensing device as described in US Pat. No. 5,927,349, the contents of which are incorporated herein by reference,
If an incorrect stock solution was detected flowing through one of the conduits 32, an alarm could be communicated. Similarly, the exact amount of ingredients transferred to the final bag 46 during and after compounding can be transferred to the controller 10.

Upon receipt of the amount of ingredients being transferred during the formulation, the controller 10 may present cost data to the pharmacist or communicate such data to the hospital computer system 28. Controller 10 may adjust this cost data to reflect the actual cost of supplying this mixture. As an example, some ingredients may be placed in a container that can be accessed once before being discarded. Therefore, if such an ingredient is used in an amount less than the amount in the container, the controller 10 will control the cost of the entire container as opposed to some of the ingredients used in the mixture. Is displayed.

From the above, it should be appreciated that improved methods and devices for controlling the preparation of parenteral mixtures have been described, thus sacrificing safety in any manner. Without, its faster and more efficient preparation is obtained. In addition, some features provide additional protection. The present invention uses extensive analysis of mixture components to ensure that such prescription mixtures can be prepared safely and reliably in a manner that not only violates known preparation rules, but also meets certain user-defined priorities. In addition, it utilizes the known properties of the ingredients in a novel manner to control the compounder.

While various embodiments of the invention have been shown and described, it should be understood that other modifications, substitutions and alternatives will be apparent to those skilled in the art.

[Brief description of drawings]

FIG. 1 is a block diagram illustrating the apparatus of the present invention shown in the context of a hospital having a central billing computer and a patient computer networked with the apparatus of the present invention. , The device is also operably connected to the blender and printer.

FIG. 2 is a perspective view of a typical compounder that may be controlled with the method and apparatus of the present invention, which specifically includes a funnel or an intermediate container (where the ingredients are transferred to the final bag). Prior to being placed, either sequentially or simultaneously).

FIG. 3 is a perspective view of a second exemplary compounder that may be controlled with the method and apparatus of the present invention.

FIG. 4a includes a flow chart for controlling the formulation of a given mixture in accordance with the present invention.

FIG. 4b includes a flow chart for controlling the formulation of a given mixture according to the present invention.

FIG. 4c includes a flow chart for controlling the formulation of a given mixture according to the present invention.

FIG. 4d includes a flow chart for controlling the formulation of a given mixture in accordance with the present invention.

FIG. 4e includes a flow chart for controlling the formulation of a given mixture according to the present invention.

FIG. 4f includes a flow chart for controlling the formulation of a given mixture according to the present invention.

FIG. 4g includes a flow chart for controlling the formulation of a given mixture in accordance with the present invention.

FIG. 4h includes a flow chart for controlling the formulation of a given mixture according to the present invention.

─────────────────────────────────────────────────── ─── Continuation of front page (51) Int.Cl. ⁷ Identification code FI theme code (reference) A61J 3/00 B01F 15/00 D 312 15/04 B01F 15/00 A61J 3/00 314Z 15/04 1 / 00 390P (81) Designated countries EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE, TR), AE , AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, BZ, CA, CH, CN, CR, CU, CZ, DE, DK, DM, DZ, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE, KG, KP, KR, KZ, LC, LK, LR LS, LT, LU, LV, MA, MD, MG, MK, MN, MX, MZ, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM , TR, TT, TZ, UA, UG, UZ, VN, YU, ZA, ZW (72) Inventor Kusani, Ronald W .. United States Illinois 60013, Kary, Ivaho Lane 82 (72) Inventor Lewis, Robert E. United States Illinois 60046, Lindenhurst, Woodlane Drive 2108 (72) Inventor Nitsuki George, Diane Em. United States Illinois 60015, Dearfield, Locust Place 401 (72) Inventor Miller, Joseph E. United States Illinois 60047, Lake Zurich, Seby Lane 226 F Term (reference) 4G036 AC65 4G037 BA00 BC00 BD03 BE02 EA00

Claims (31)

[Claims] 1. At least one pharmaceutical preparation adapted to selectively transfer a predetermined amount of a pharmaceutical ingredient from an individual source container through an elongated hollow transfer means to a final container for preparing a formulation mixture. A device used to control the operation of a blender, the device comprising the following parts: computing means, the computing means operating the device to control the blender to a predetermined A storage means for storing instructions for preparing the mixture of, the storage means adapted to control data associated with a plurality of the pharmaceutical ingredients that may be moved to prepare the formulation mixture and the device. Data relating to at least one operating characteristic of the compounding machine, the calculating means including at least one communication port establishing a communication link with each compounding machine to be controlled; Accept the formulation mixture and Of the pharmaceutical ingredients, determining the compatibility of the pharmaceutical ingredients with each other, determining the order in which the ingredients are moved in preparing the formulation mixture, and the formulation used in preparing the formulation mixture. A device adapted to convey the instructions to the machine to prepare the formulation mixture. 2. The apparatus according to claim 1, wherein the calculating means is adapted to convert the amount of each component into an index that the compounding machine that prepares the formulation mixture can move. 3. The calculating means is adapted to convert the indicated component volume in the formulation mixture into the weight index by multiplying the specific gravity of the component by the volume indicated in the formulation mixture. The device according to claim 2. 4. The data relating to the plurality of pharmaceutical ingredients comprises a database having a plurality of compatible groups, each group having at least one of the pharmaceutical ingredients, the database also being of each group. The device of claim 1, having data identifying compatibility and / or incompatibility with other groups. 5. The method of claim 4, wherein at least a first one of the compatibility groups contains a component that comprises lipids and a second one of the compatibility groups contains a component that is sterile water. The described device. 6. The calculating means determines an order of moving the components, the order according to a set of general rules of mixing order, the general rule adding phosphate before calcium salt. Determining the solubility of calcium phosphate based on the volume of solution in the formulation mixture at the time of adding calcium; and calcium being the last additive to the formulation mixture. The device according to 4.:. 7. The calculation means determines the number and position of rinses to be performed during the sequence of transfer of components, the rinse using a solution that is compatible with subsequent components to be transferred to the final container. 7. The apparatus of claim 6, wherein at least a portion of the elongated hollow transfer means proximate the final container is washed. 8. The apparatus of claim 6, wherein the wash solution is removed from one of the individual source vessels or the final vessel. 9. The lipid-containing pharmaceutical ingredient is characterized in that the order of movement is such that the calculating means is such that the lipid-containing ingredient has been transferred either first or last with respect to all other pharmaceutical ingredients. 5. The apparatus of claim 4, including at least one port that accepts input data for selecting whether to make a decision. 10. The apparatus of claim 1, wherein the contact link can comprise at least one of an internet connection, a local area network connection and a wireless connection. 11. The device is adapted for use by a user in at least two positions, wherein each position is at least one compounder, a printer for printing labels, a display input device for inputting a prescription mixture. And a selectable setting associated with the operation of the apparatus and the compounder.
The device according to. 12. The computing means is adapted to control two blenders at each position such that one blender moves components at a significantly faster flow rate than another blender. The device of claim 11, which is adapted. 13. The presence of the lipid component in the formulation mixture currently prepared by the user so that the computing means examines the formulation mixture to determine if the lipid component is a part thereof. To determine whether to reject the next formulation mixture prepared with the expected cloudy appearance, to stop the preparation of the formulation mixture when the user expresses a rejection, and 10. The device of claim 9, adapted to issue such an expected cloudy warning if the user does not indicate a refusal. 14. The computing means is adapted to receive a plurality of formulation mixtures and queue them in a preparation queue, the computing means inspecting each formulation mixture in the queue. Adapted to determine the commonality of the given ingredients therein and to reorder the formulation mixtures in the queue to classify together the formulation mixtures having such commonality of the given ingredients. The device of claim 9, wherein 15. The computing means is adapted to retrieve data related to a profile of a patient preparing a prescription mixture, wherein the patient profile data is at least the name, age and age of the patient. Including weight, the calculating means being adapted to collect data relating to patients in multiple categories, each category comprising a predetermined limit of mixture components specific to each category, the calculating means comprising: Adapted to compare the amounts of the ingredients in the prescription mixture for one patient in the category, and to produce a signal when the ingredient is outside the predetermined limits of the ingredients in the prescription mixture An apparatus according to claim 1. 16. The device of claim 15, wherein the patient categories include adult patients, pediatric patients, neonatal patients and premature babies. 17. The device of claim 15, wherein the signal is adapted to prevent the formulation mixture from being prepared. 18. The patient profile data further comprises a history of the patient's weight and mixture prescription over an extended period of time, the processing means including a prediction of the patient's weight at a future time. 16. The device of claim 15, adapted to produce a report on a patient. 19. The computing means is adapted to retrieve data relating to a profile of a patient preparing a prescription mixture, wherein the patient profile data is at least the name, age and age of the patient. Wherein the calculation means is adapted to collect data relating to the limits of the amount of mixture components that can be added to a particular patient's prescription mixture, including the body weight, and said calculation means in a prescription mixture for a patient. 2. It is adapted to compare the amounts of the components of, and to require a data permitting input to explain the rationale for one or more of such limits. apparatus. 20. The apparatus according to claim 19, wherein the data permission input is at least a data input by a doctor or a pharmacist. 21. The apparatus of claim 19, wherein the computing means halts the preparation of the formulation mixture as a result of lack of necessary data to explain the rationale for exceeding one or more of such limits. . 22. The storage means includes data relating to the amount of fluid required to prepare the blender from a raw material container through the elongated hollow transfer means to the final container, the processing means comprising: The apparatus of claim 1, adapted to increase the amount of ingredients by the amount required to prepare the compounder. 23. The processing means is adapted to receive a switchable input associated with the preparation of a mixture formulation, the input comprising a predetermined amount of a first component, a diluent for the first component. A quantity, and a relatively small amount of one or more additional ingredients, where:
The total mixture formulation should be in a predetermined total amount, and the calculating means may substitute a relatively small volume of the one or more additional components as an alternative to the same diluent volume so that the predetermined total amount is not exceeded. The device of claim 1, adapted for use. 24. At least one pharmaceutical product adapted to selectively transfer a predetermined amount of a pharmaceutical ingredient from an individual source container through an elongated hollow transfer means to a final container to prepare a formulation mixture. A method of controlling the operation of a blender, the method utilizing a computing means, the computing means storing storage instructions for operating the device to control the blender to prepare a predetermined mixture. The storage means includes data relating to the plurality of pharmaceutical ingredients that may be moved to prepare the formulation mixture, and operation of at least one of the compounding machines adapted to be controlled by the device. Including characteristic-related data, the calculating means including at least one communication port establishing a communication link with each compounder to be controlled, the method comprising the steps of: prescribing in the calculating means Accepts a mixture Identifying and determining the amount of the pharmaceutical ingredients of the formulation mixture; determining the compatibility of the pharmaceutical ingredients with each other; determining the order in which the components are transferred during the preparation of the formulation mixture; and Communicating the command to prepare the formulation mixture to the at least one compounder used to prepare the formulation mixture. 25. The step of identifying and determining the amount comprises the step of converting the amount of each component into a movable index for the compounding machine to prepare the formulation mixture,
The method of claim 24. 26. The data relating to a plurality of pharmaceutical ingredients comprises a database of pharmaceutical ingredients classified into a plurality of groups, the ingredients of each group having common compatibility characteristics, the database comprising: Having data identifying compatibility and / or incompatibility of each group with other groups, the compatibility determining step further comprising examining the prescription mixture to identify the particular group present therein. 25. The method of claim 24, comprising the step of identifying the compatibility characteristics of each group with respect to the components of and other identified groups. 27. The step of determining the order further comprises the step of determining the order of mixing such that components compatible with each other within the group are added to the final vessel simultaneously or sequentially consistent with known general mixing rules. 27. The method of claim 26, comprising. 28. The known general mixing rule is: adding phosphate before calcium salt; determining the solubility of calcium phosphate based on the solution volume in the formulation mixture upon addition of calcium; and 28. The method of claim 27, comprising the final addition of calcium to the formulation mixture. 29. The step of determining the order further comprises the step of determining the order of mixing, whereby ingredients that are mutually compatible within the county are sequentially added to the final container, resulting in a number of rinses. As much as possible and the rinse cleans the elongated hollow transfer means near the final container because the components of one group are incompatible with the next component in the other group to be transferred. 27. The method of claim 26, performed as follows. 30. The step of identifying and determining the amount of the pharmaceutical ingredient further comprises:
25. The method of claim 24, comprising identifying a lipid as a component of the formulation mixture and, if the user chooses an option to stop the preparation of the formulation mixture, providing it to the user. 31. The method of claim 30, wherein if the lipid-containing formulation mixture is not stopped, a warning is issued that the formulation formulation to be prepared next may have a cloudy appearance due to the presence of lipids.