CH661878A5 - Capsule dosing forms. - Google Patents

Capsule dosing forms. Download PDF

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Publication number
CH661878A5
CH661878A5 CH4939/84A CH493984A CH661878A5 CH 661878 A5 CH661878 A5 CH 661878A5 CH 4939/84 A CH4939/84 A CH 4939/84A CH 493984 A CH493984 A CH 493984A CH 661878 A5 CH661878 A5 CH 661878A5
Authority
CH
Switzerland
Prior art keywords
capsule
characterized
units
water
starch
Prior art date
Application number
CH4939/84A
Other languages
German (de)
Inventor
Fritz Wittwer
Louis S Gillow
Original Assignee
Warner Lambert Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US54879483A priority Critical
Priority to US64166484A priority
Application filed by Warner Lambert Co filed Critical Warner Lambert Co
Publication of CH661878A5 publication Critical patent/CH661878A5/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/56Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using mechanical means or mechanical connections, e.g. form-fits
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/56Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using mechanical means or mechanical connections, e.g. form-fits
    • B29C65/58Snap connection
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/10Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/11Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
    • B29C66/112Single lapped joints
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/10Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/11Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
    • B29C66/112Single lapped joints
    • B29C66/1122Single lap to lap joints, i.e. overlap joints
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/10Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/11Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
    • B29C66/114Single butt joints
    • B29C66/1142Single butt to butt joints
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/10Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/13Single flanged joints; Fin-type joints; Single hem joints; Edge joints; Interpenetrating fingered joints; Other specific particular designs of joint cross-sections not provided for in groups B29C66/11 - B29C66/12
    • B29C66/131Single flanged joints, i.e. one of the parts to be joined being rigid and flanged in the joint area
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/10Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/13Single flanged joints; Fin-type joints; Single hem joints; Edge joints; Interpenetrating fingered joints; Other specific particular designs of joint cross-sections not provided for in groups B29C66/11 - B29C66/12
    • B29C66/131Single flanged joints, i.e. one of the parts to be joined being rigid and flanged in the joint area
    • B29C66/1312Single flange to flange joints, the parts to be joined being rigid
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/20Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines
    • B29C66/24Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight
    • B29C66/242Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being closed, i.e. forming closed contours
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/20Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines
    • B29C66/24Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight
    • B29C66/242Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being closed, i.e. forming closed contours
    • B29C66/2422Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being closed, i.e. forming closed contours being circular, oval or elliptical
    • B29C66/24221Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being closed, i.e. forming closed contours being circular, oval or elliptical being circular
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/20Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines
    • B29C66/24Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight
    • B29C66/242Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being closed, i.e. forming closed contours
    • B29C66/2424Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being closed, i.e. forming closed contours being a closed polygonal chain
    • B29C66/24241Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being closed, i.e. forming closed contours being a closed polygonal chain forming a triangle
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/20Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines
    • B29C66/24Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight
    • B29C66/242Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being closed, i.e. forming closed contours
    • B29C66/2424Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being closed, i.e. forming closed contours being a closed polygonal chain
    • B29C66/24243Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being closed, i.e. forming closed contours being a closed polygonal chain forming a quadrilateral
    • B29C66/24244Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being closed, i.e. forming closed contours being a closed polygonal chain forming a quadrilateral forming a rectangle
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/53Joining single elements to tubular articles, hollow articles or bars
    • B29C66/534Joining single elements to open ends of tubular or hollow articles or to the ends of bars
    • B29C66/5346Joining single elements to open ends of tubular or hollow articles or to the ends of bars said single elements being substantially flat
    • B29C66/53461Joining single elements to open ends of tubular or hollow articles or to the ends of bars said single elements being substantially flat joining substantially flat covers and/or substantially flat bottoms to open ends of container bodies
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/54Joining several hollow-preforms, e.g. half-shells, to form hollow articles, e.g. for making balls, containers; Joining several hollow-preforms, e.g. half-cylinders, to form tubular articles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/54Joining several hollow-preforms, e.g. half-shells, to form hollow articles, e.g. for making balls, containers; Joining several hollow-preforms, e.g. half-cylinders, to form tubular articles
    • B29C66/542Joining several hollow-preforms, e.g. half-shells, to form hollow articles, e.g. for making balls, containers; Joining several hollow-preforms, e.g. half-cylinders, to form tubular articles joining hollow covers or hollow bottoms to open ends of container bodies
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/54Joining several hollow-preforms, e.g. half-shells, to form hollow articles, e.g. for making balls, containers; Joining several hollow-preforms, e.g. half-cylinders, to form tubular articles
    • B29C66/543Joining several hollow-preforms, e.g. half-shells, to form hollow articles, e.g. for making balls, containers; Joining several hollow-preforms, e.g. half-cylinders, to form tubular articles joining more than two hollow-preforms to form said hollow articles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/63Internally supporting the article during joining
    • B29C66/636Internally supporting the article during joining using a support which remains in the joined object
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/54Joining several hollow-preforms, e.g. half-shells, to form hollow articles, e.g. for making balls, containers; Joining several hollow-preforms, e.g. half-cylinders, to form tubular articles
    • B29C66/545Joining several hollow-preforms, e.g. half-shells, to form hollow articles, e.g. for making balls, containers; Joining several hollow-preforms, e.g. half-cylinders, to form tubular articles one hollow-preform being placed inside the other
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/70General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/71General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined

Description

The present invention relates to dosage forms of hard-shell capsules for the metered administration of solid, creamy and liquid substances, in particular pharmaceuticals.

The dosage form of the present invention consists of two or more capsules connected together. The capsule connecting pieces can be produced in one step with the capsule production by printing forms and from the same materials as the capsules. Furthermore, the capsules can contain two or more inseparable sections or sectors in each capsule to accommodate different medications. The types of capsules according to the invention can be produced as a large number of individual doses or as packs. Previously known capsules for pharmaceutical use have only a single container for holding filling material, namely the cavity of the capsule obtained by pushing the cap and body parts together.

It is known that tablets offer the patient the option of e.g. to choose by breaking apart into pieces. According to the present invention, capsule containing two or more medicaments which could not be combined in a tablet or in capsules which were customary hitherto can now be produced using compression molding techniques, preferably by means of injection molding, since their active substances, e.g. react with each other to unwanted products.

Capsule dosage forms according to the present invention can be divided into smaller units and swallowed. The articles of the present invention can be made by compression molding, preferably injection molding starch, hydrophilic polymers such as gelatin, or starch derivatives, all with low water contents.

In injection molding, it is important that the molten material to be molded behaves like a thermoplastic material during the molding process and then solidifies in the mold so quickly that it can be ejected from the mold quickly and without changing its dimensions. The latter is therefore of particular importance, since most of the pressure-molded articles require a high degree of dimensional stability. The articles according to the invention can be produced with the greatest accuracy and dimensional stability by pressure molding, in particular injection molding.

The method for producing the capsule forms according to the invention is characterized in that they are produced from a hydrophilic polymer or a mixture of such polymers with a water content of 5-25% (calculated on the hydrophilic polymer / water mixture), in which case the capsule forms are made of gelatin, which has a water content of 10-20% by weight (calculated on the water-containing gelatin-water mixture), and in the event that they are produced from starch or a starch mixture, the latter has a water content of 5 - 25% by weight, preferably 15-21% by weight (calculated on the starch / water mixture).

The present invention relates to divisible hard-shell capsule shapes, characterized in that the individual capsule units, each consisting of a cap part and a body part which can be pushed into one another, are connected to one another in such a way that the individual capsule units can be easily separated from one another.

The present invention also relates to hard-shell capsule forms, consisting of a cap part and a body part, characterized in that the body part has several departments. These individual capsule units can be connected to larger units by means of one or more lamellae. The body part and / or the cap part can be connected to a lamella.

The invention further relates to hard-shell capsule packs, characterized in that the individual capsule units, each consisting of a cap part and a body part which can be pushed into one another, are connected to one another in such a way that the individual capsule units can be easily separated from one another. The interconnected capsule units of the present invention are preferably interconnected by one or more thin lamellae; these connected units are preferably produced in a single operation by means of the injection molding process.

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According to the invention, the individual capsule units or the individual departments of a body part can e.g. be filled with different medicines.

The capsule units can be used for the precise dosing of solid, liquid and creamy substances, mainly in the pharmaceutical field.

Preferred capsules according to the present invention are made from starch by injection molding.

Injection molding of hydrophilic material, e.g. hydrous gelatin, is in the European Patent Pub. No. 92 908 and forms part of the present invention.

Hydrophilic polymers are polymers with molecular masses of approximately IO3 to 107 daltons which contain molecular groups in their main chain and / or in side chains which are capable of forming and / or participating in hydrogen bonds. The processing temperatures for these materials are in the range of preferably 70-190 ° C, preferably 80-190 ° C.

If gelatin is used as the hydrophilic polymer, this is produced e.g. by acidic or alkaline treatment of collagen, acidic treatment of pig skin or alkaline treatment of cattle hides. These types of gelatin preferably have molecular weights in the range from 10,000 to 2 x 107 daltons or molecular weights in the range from 10,000 to 2 x 106 and 10 x 106 to 20 x 106 daltons. The gelatin used has a water content of preferably 10-19%, particularly preferably 12-18% by weight, based on the water-containing gelatin mixture.

Various additives such as plasticizers, lubricants, crosslinking agents and dyes can be added to all hydrophilic polymers, including gelatin - as in the European patent application Pubi. No. 92 908 described - are added. The hydrophilic polymers can also contain up to 95% - preferably not more than 30% by weight of extenders such as proteins e.g. Sunflower proteins, soybean proteins, cottonseed proteins; Peanut proteins, blood proteins, egg proteins, rapeseed proteins and their acrylated derivatives, cross-linked gelatin, vinyl acetate, polysaccharides such as cellulose, methyl cellulose, hydroxymethyl cellulose, sodium carboxymethyl cellulose, agar agar, gum arabic, guar, dextran, chitin, polymalto Contain polyfructose, pectin, alginates, alginate acid, monosaccharides such as glucose, fructose, sucrose, oligosaccharides such as lactose, polyvinylpyrrolidone, silicates, bentonites, carbonates or bicarbonates.

Some of these extenders are themselves hydrophilic polymers and can be used as such for the production of articles according to the invention. Such hydrophilic polymers are hydroxypropyl methyl cellulose phthalate (HPMCP) polyvinyl acetate phthalate (PVAP), cellulose acetyl phthalate (CAP), acrylates and methacrylates, gelatin treated with phthalic acid, succinic acid or crotonic acid and shellac. These polymers are preferred when Entero properties are desired. They preferably contain 5-25% water, particularly preferably 15-22% by weight based on the water-containing polymer. HPMCP, PVAP and CAP, particularly PVAP and CAP, are preferred. Most preferred, however, is PVAP, all of which are processed by injection molding and with a water content of 5-25%, preferably 15% -21% by weight, based on the mixture.

Some of these polymers are not thermoplastic, and it is therefore all the more surprising that they can be processed in printing form processes. The processing temperature is in the range from 70 ° C to 190 ° C and the pressure in the range from 600 to 3000 x 105 N / m2; machines known per se can be used.

A moldable starch mixture of corn, wheat, potato, rice and / or tapioca starch is preferred. The starch contains approximately 0 to 100% amylose and approximately 100 to 0% amylopectin, preferably 0 to 70% amylose and approximately 100 to 30% amylopectin. Potato or corn starch is particularly preferred.

In the following, the terms “starch” and “gelatin” also include foams, modifications or derivatives of starch and gelatin and their combination with hydrophilic polymers, the properties of which are suitable for pressure or injection molding, in particular for the manufacture of capsules.

The starch to be used has a water content of 5-25%, preferably 15-21% and particularly preferably 17-20% by weight, based on the starch mixture. It can also contain various additives such as plasticizers, lubricants, crosslinking agents and / or dyes and extenders. The same compounds as described above for the hydrophilic polymers can be used for this. The processing temperature for the injection molding of starch is between 80 ° and 240 C, at a pressure in the range of 600 to 3000 x 105 N / m2.

The water-containing starch, which may contain further additives, is processed at these temperatures and pressures and in known injection molding machines in a manner known per se.

Articles according to the invention can also be produced by profile extrusion, molding, vacuum molding, thermal molding, extrusion, casting in combination with vacuum molding. However, injection molding is preferred.

The advantages of the present invention are explained in more detail by the following detailed description.

Detailed description

The embodiments of the present invention can be divided into 3 groups.

1) Divisible or separable capsule

The divisible capsule can be swallowed whole or it can be divided into parts that can be swallowed individually. For this reason, both the connected capsules and the separated pieces have a shape that can be easily swallowed and that can also indicate the area of application. The body part or the cap part or both parts can be connected by a lamella. An embodiment of this group is shown in FIGS. 1, 2, 3 and 4, which represents a perspective view of a separable capsule, consisting of 2 units, each consisting of a cap part 2 and a body part 1. As can be seen from FIG. 2, which shows a section along the line 2-2 of FIG. 1, the two body parts 1 are connected by a weak lamella 5. The two cap parts 2, however, are not connected. FIG. 3, which represents a further view of FIG. 1, shows this dosage form after filling, or before the cap parts 2 have been placed on the body parts 1. FIG. 4 is a side view of FIG. 3 after the cap parts 2 have been put on the body parts 1. This embodiment according to FIGS. 1-4 can be swallowed as a whole capsule, or else it can be divided along the lamella 5 into smaller units, which in turn can be swallowed individually. The two parts of the divisible capsule according to FIGS. 1-4 can be filled with different or with the same medication. In the case of filling in the same medication, the dose is halved by breaking apart. However, if 2 different medications are filled into the two capsule parts, the desired combination can be canceled

5

10th

15

20th

25th

30th

35

40

45

50

55

60

65

661878

Capsule to be swallowed by the lamella. To mark the content of the two parts, the two parts can either be made in different colors or printed differently. The capsule parts 1 and 2 and the lamella 5 connecting them can be produced in one operation by pressure molding, preferably injection molding. The connecting piece 5 is made of the same material as the capsule parts 1 and 2.

5 and 6 show a further embodiment of a capsule with 4 divisions. Fig. 5 is a plan view and Fig. 6 is a side view of Fig. 5 showing 4 cap parts 2 and 4 body parts 1 connected by a weak sipe 5. This capsule can be taken as a whole or the 4 parts can be taken individually. The capsule parts or subdivisions can be filled with the same or different medications. Further embodiments are shown in FIGS. 7 to 12. The numerical designations here are as in FIGS. 1-6. In this embodiment, the cap parts 2 are connected to the body parts 1 by weak connections as shown in FIGS. 11 and 12. The cap parts 2 can overlap the body parts 1. Furthermore, the cap parts 2 can have an indentation 6 from the connection point of the lamella 5, so that the lamella is difficult to see even after the individual parts have broken apart.

Another embodiment is shown in FIGS. 13 and 14, in which the capsule consists of 3 parts, which have an inner and 2 outer parts, each of which in turn consists of a body part 1 and a cap part 2. 13 and 14, the outer parts are triangular. On the other hand, the outer parts may have a semicircular shape as in FIGS. 15 and 16. According to the embodiments in FIGS. 13-16, only the body parts 1 are connected to slats 5, but the caps are individual parts.

3) capsule pack

A capsule pack consists of 2 or more capsules that are connected to each other so that they can be separated into individual capsule units. These capsule packs should not be swallowed whole, but rather represent a suitable form of storage z. B. in the event that each unit should be taken periodically.

The number of parts connected in total is not limited. Capsule packs can also be used to combine group 1 divisible capsules and group 2 capsules divided into compartments. An embodiment of this group is shown in FIGS. 17 and 18. Figure 12 is a plan view showing the capsules lined up along their axis. Fig. 18 is a section of Fig. 17 along line 22, in which the connection of the capsule body 1 through the lamellae 5, which consist of the same material as the capsule body 1 and were obtained by simultaneous pressure molding, can be seen. The cap parts 2 of the capsule pack are not connected to one another. Both the body parts 1 and the cap parts 2 can be provided with locking mechanisms in order to obtain a secure closure. Another embodiment of the capsule pack is shown in FIGS. 19 and 24. Fig. 19 is a plan view showing the circular arrangement of the capsule units. FIG. 20 is a section along the line 24-24 of FIG. 19, the capsule bodies 1 being connected to one another by the connecting pieces 5, which are made of the same material as the capsule bodies 1. These connectors 5 are made simultaneously with the capsule bodies. Both parts, i.e. the bodies 1 and the caps 2 can also be provided with closure mechanisms, io Another embodiment of the capsule pack is shown in FIGS. 21 and 22; it is used to combine two different drugs. Fig. 21 is a plan view showing the capsules hanging on the connector 5. Fig. 22 is a section along line 26-26 of Fig. 21, showing i5 how capsule body 1 and caps 2 are made simultaneously without printing forms. The cap parts are not connected to each other. The capsules are arranged in 2 rows so that the 2 medications can be filled into the abutting body parts. 20 blister packs are known for packaging pharmaceutical and other products that require high dosage accuracy. It is a further feature of the present invention that hard-shell capsules can be produced from the blister pack components of a blister shell and a cover sheet that have been heat and pressure sealed after the blister shell has been filled with a medicament. According to the invention, the blister pack components are produced from water-soluble and edible hydrophilic polymers.

23 is a plan view of an embodiment of a capsule blister pack in which the blister sheet has 10 different divisions 11, 12, 13, 14 ... FIG. 24 is a section along line 28-28 of FIG. 23, the blister sheet 10 being welded to the cover sheet 15 by pressure and heat and the blister divisions 11, 12, 13, 14 ... to the medication were sealed in it. At the interface between the blister sheet 10 and the cover sheet 15, perforations 16 can be attached to make it easier to separate the blister 40 chambers 13, 14 .... 25, 26, 27 and 28 show other embodiments of capsule blister packs using the same numerical designations as in Figs. 23 and 24. 25 and 26 show capsule blister packs, the blister sheets 10 and the 45 cover sheets 15 having symmetrical divisions 13, 14. 27 and 28 show capsule blister packs in which each unit 11 and 12 is subdivided into further chambers 17, 18, 19, 20 for receiving various medicaments.

The present invention also includes the sealing and closing of the nested capsule parts or closed and sealed capsules. This sealing offers further protection against separation and falsification of the contents of the capsule, and also makes the capsule moisture and gas tight. 55 capsules according to the invention can be used for pharmaceutical purposes, but also for the exact, quantitative dosing of dyes, chemicals, spices, fertilizer combinations for plants, fertilizers with protective substances, seeds, cosmetics, agricultural products etc.

65

7 sheets of drawings

Claims (11)

661 878 PATENT CLAIMS
1. Divisible hard-shell capsule shapes, characterized in that the individual capsule units, each consisting of a cap part and a body part which can be pushed into one another, are connected to one another in such a way that the individual capsule units can be easily separated from one another.
2. Capsule forms according to claim 1, characterized in that they are produced as a plurality of individual doses or as packs.
3. Hard-shell capsule shapes according to claim 1, consisting of a cap part and a body part, characterized in that the body part has several departments.
4. Capsule forms according to one of the claims 1-3, characterized in that the capsule units are connected to larger units by means of one or more lamellae.
5. Capsule shapes according to one of the claims 1-4, characterized in that the body part and / or the cap part of the capsule units is or are connected to a lamella.
6. Process for the production of capsule forms according to one of the claims 1-5, characterized in that they are produced from a hydrophilic polymer or a mixture of such polymers with a water content of 5-25% (calculated on the hydrophilic polymer / water mixture). In the event that the capsule forms are made from gelatin, this has a water content of 10-20% by weight (calculated on the water-containing gelatin-water mixture).
7. Process for the production of capsule forms according to one of the claims 1-5, characterized in that they are made from starch or a starch mixture with a water content of 5-25% by weight (calculated on the water-containing starch-water mixture).
8. The method according to claim 6 or 7, characterized in that the capsule shapes are produced by injection molding.
9. The method according to claim 6 or 7, characterized in that the capsule shapes are sealed.
10. Use of the capsule forms according to one of claims 1-5, for precise dosing of dyes, chemicals, spices, fertilizer combinations for plants, fertilizers with protective substances, seeds, cosmetics or agricultural products.
11. Capsule forms according to one of claims 1 - 5, which contain precisely metered amounts of pharmaceuticals, dyes, chemicals, spices, fertilizers, seeds, cosmetics or agricultural products.
CH4939/84A 1983-11-04 1984-10-16 Capsule dosing forms. CH661878A5 (en)

Priority Applications (2)

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US54879483A true 1983-11-04 1983-11-04
US64166484A true 1984-08-17 1984-08-17

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CH4939/84A CH661878A5 (en) 1983-11-04 1984-10-16 Capsule dosing forms.

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JP (1) JPH0673539B2 (en)
BE (1) BE900950A (en)
CH (1) CH661878A5 (en)
DE (1) DE3438656A1 (en)
FR (1) FR2554418B1 (en)
GB (1) GB2148841B (en)
IT (1) IT1178193B (en)

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IT1178193B (en) 1987-09-09
GB8427523D0 (en) 1984-12-05
JPH0673539B2 (en) 1994-09-21
GB2148841B (en) 1987-07-01
IT8449110D0 (en) 1984-11-02
FR2554418A1 (en) 1985-05-10
BE900950A1 (en)
FR2554418B1 (en) 1989-11-24
JPS60132562A (en) 1985-07-15
GB2148841A (en) 1985-06-05
BE900950A (en) 1985-04-30
DE3438656A1 (en) 1985-05-23

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