WO1999020249A1 - Solution destinee a une dialyse perotoneale et son procede de production - Google Patents

Solution destinee a une dialyse perotoneale et son procede de production Download PDF

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Publication number
WO1999020249A1
WO1999020249A1 PCT/SE1998/001831 SE9801831W WO9920249A1 WO 1999020249 A1 WO1999020249 A1 WO 1999020249A1 SE 9801831 W SE9801831 W SE 9801831W WO 9920249 A1 WO9920249 A1 WO 9920249A1
Authority
WO
WIPO (PCT)
Prior art keywords
solution
glucose
solutions
sterile
peritoneal dialysis
Prior art date
Application number
PCT/SE1998/001831
Other languages
English (en)
Inventor
Bengt Julander
Mikael Bender
Original Assignee
Pharmalink Ab
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
Application filed by Pharmalink Ab filed Critical Pharmalink Ab
Priority to AU96566/98A priority Critical patent/AU9656698A/en
Priority to JP2000516649A priority patent/JP2001520183A/ja
Priority to EP98950558A priority patent/EP1024789A1/fr
Publication of WO1999020249A1 publication Critical patent/WO1999020249A1/fr
Priority to NO20002008A priority patent/NO20002008L/no

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A61M1/287—Dialysates therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/002—Compounding apparatus specially for enteral or parenteral nutritive solutions

Definitions

  • the present invention relates to the production of sterile solutions comprising glucose and in particular ready-to-use solutions for peritoneal dialysis (PD).
  • PD peritoneal dialysis
  • PD solutions Sterile glucose solutions are commonly used in the medical field.
  • the glucose concentration ranges from 50 to 300 mg/ml and the solutions are used for intravenous (IV) infusion and as peritoneal dialysis (PD) solutions.
  • IV intravenous
  • PD peritoneal dialysis
  • Peritoneal dialysis is used as a treatment for renal dysfunction, as in acute and chronic renal insufficiency, hypercalcemia, metabolic acidosis and in some cases of intractable oedemas.
  • the major consumption of PD solutions is however in self administered peritoneal dialysis. Whereas out patient dialysis at dialysis clinics is both time consuming and costly, PD can be performed at home, by the patient himself/herself. There .are many benefits with PD and this treatment is gaining in popularity.
  • the glucose is administered as a source of energy to a patient, in situations when the patient cannot eat.
  • a PD solution the glucose functions as an osmotic particle in the solution.
  • the glucose molecule only slowly penetrates the peritoneal membrane. Consequently the concentration gradient draws fluid from the rest of the patient's body into the peritoneal cavity.
  • peritoneal dialysis is a lifelong treatment.
  • a normal daily volume is 8 1, which makes about 3000 1 annually.
  • Even minor contaminations of the glucose solution must therefor be avoided. For example a contamination of 1 ⁇ g/ml amounts to about 15 g over a 5 year period.
  • Glucose is known to partially degrade to aldehydes, mainly 5-hydroxy-methyl-2- furalaldehyde (5-HMF). Polymerisation of 5-HMF and other degradation compounds results in a brownish hue, known as the caramellisation effect.
  • the degradation of glucose is dependent on time, temperature and pH. At room temperature and low pH the degradation process is slow. At higher temperatures, such as sterilisation temperatures, and at physiological pH the degradation is significant.
  • the mass transfer over the peritoneal membranes is influenced by several factors.
  • the transport of liquid and solutes is through the capillary wall, the interstitial space and through the mesotelial cells.
  • the main route is nevertheless the capillary wall but for small molecules, the interstitial space is an important route, specially through so called unstirred layers.
  • the permeability of the peritoneum is surprisingly well preserved with time. However, about 30 % of all patients develop after 3 to 5 years of treatment an increased permeability for small molecules as the permeability for macro molecules remains unchanged. This usually lowers the efficiency of ultrafiltration and thus of the PD treatment as a whole. There are indications that it is the interstitial transport that is affected in CAPD patients.
  • the base substance of the interstices has a gel/sol structure with varying concentration of liquid, i.e. alternating gel and sol areas.
  • the structure of this base substance is dependent of its contents of hyaluronic acid (HA).
  • HA hyaluronic acid
  • This base substance comprises proteoglucans and collagenic and elastic fibres.
  • the main purpose of the HA molecules is to keep water in gel phase.
  • One assumption is, that the this gel layer is leached with time and step-by-step displaced by a harder net of fibrotic character, including channels with free liquid. These channels would then be more permeable for small molecules and perhaps also for water than the normal gel structure. This might be the principal reason for the increased transport of minor solutes in patients with long term CAPD.
  • WO 93/09820 teaches a double compartment bag, where an acid glucose concentrate is enclosed in one first compartment and a basic salt solution in one second compartment of the same bag, separated by a weld and connected by a tube containing a suitable breakable seal, for example a conventional breakpin. This technical solution is however not satisfactory for several reasons.
  • the double compartment bag is not ready to be used by the patient.
  • the patient is required to break the seal between the compartments and make certain that the two solutions are properly mixed.
  • the breakable seal is difficult or impossible to manipulate.
  • the many steps required i.e. breaking the seal, mixing the contents and waiting for equilibrium, require too much concentration and effort.
  • sterilising the acid glucose concentrate in the PVC bags commonly used as PD bags causes potassium stearate to leach from the plastic.
  • the problem to be solved by the present invention is therefor not only that of sterilisation of easily degraded and/or incompatible constituents in solution and how to avoid unwanted contamination in as large extent as possible, but also to make available a ready-to- use PD solution with beneficial properties, optionally such as nutritive properties.
  • the invention aims to solve the problem of producing a PD solution, with a minimised content of unwanted degradation products, chemical contamination and physiological or near-physiological properties, causing minimal discomfort to a patient, subjected to PD treatment.
  • the present invention aims to make available a ready-to-use PD-solution, avoiding the risk of error from the side of the patient.
  • the present invention aims to make available nutritive PD-solutions, free of unwanted contaminants.
  • Fig. 1 shows a schematic flow chart illustrating the process according to the invention
  • Fig. 2 illustrates a process according to one embodiment of the invention
  • Fig. 3 illustrates a process for large scale production according to the invention. Description of the invention
  • a first solution contains the glucose (A, 1), e.g. in the form of glucose monohydrate.
  • the glucose is mixed with pyrogene free water or water for injections (WFI) and filtrated.
  • the glucose solution is the filled in sealable vessels, suitable for sterilisation and subsequently sterilised, for example autoclaved.
  • the glucose solution is filled on glass vessels.
  • a second solution for example an electrolyte solution (B, 2) or a solution containing nutrients, fats, amino acids etc is manufactured conventionally.
  • the ingredients are mixed in WFI, filtered and the resulting solution filled in sealable vessels, suitable for sterilisation and subsequently sterilised, for example autoclaved.
  • the electrolyte solution is filled on glass vessels.
  • a third solution (not shown), e.g. a solution comprising essential amino acids, is prepared and filled in vessels, suitable for sterilisation.
  • care has to be taken in choosing the volume, concentration and pH so, that the resulting compounded volume meets the requirements regarding volume, compound concentration and pH.
  • Nutritional IV solutions have been manufactured using a similar technique, i.e. separate manufacture and sterilisation of the components, followed by combining in a process isolator. However, this process has previously not been applied to PD solutions. Schematically, the manufacture of the glucose solution comprises the following steps:
  • the equipment is steam sterilised (T > 100°C, t > 30 min).
  • BOTTLING Glass bottles are automatically filled and closed with rubber stoppers and sealed with aluminium caps.
  • STERILISATION The filled bottles are sterilised in conventional manner, e.g. steam sterilised. (In-process control 3) 9. VISUAL CONTROL & LABELLING (Q A controls)
  • QUARANTINE The bottled glucose solution is stored 1 to 2 weeks as a normal quarantine measure. (In-process control 4)
  • the manufacturing of the electrolytes solution comprises the following steps:
  • MANUFACTURING OF ELECTROLYTES SOLUTION 1. STERILISATION of tanks and pipes, including the filter. Preferably the equipment is steam sterilised (T > 100°C, t > 30 min). 2. WEIGHT CONTROL of the raw materials
  • MIXING The solution is mixed under a nitrogen atmosphere and sodium hydroxide q.s. added. (In-process control 1)
  • FILLING Suitable containers are filled with the above solution. The headspace air is replaces with nitrogen and the containers closed.
  • STERILISATION The filled bottles are sterilised in conventional manner, e.g. steam sterilised. (In-process control 3)
  • QUARANTINE The bottled glucose solution is stored 1 to 2 weeks as a normal quarantine measure. (In-process control 4)
  • the in-process controls comprise the following determinations: In-process control 1: The water for injection is tested for conductivity ⁇ 1.0 ⁇ S) and pH 5.5 - 7.0.
  • In-process control 2 The glucose solution is tested for concentration: optical rotation 98-105 % and pH 4.5 - 5.5.
  • the electrolytes solution is tested for the following concentrations: chlorides 204 mEq/l ⁇ 5% and lactates 70 mEq/l ⁇ 5%.
  • In-process control 3 Volume 1000 ml - 1100 ml
  • In-process control 4 The contents are clear and free of visible particles.
  • the compounding of the PD solution comprises the following steps: MANUFACTURING OF PD SOLUTION 1.
  • STERILISATION The surfaces of the components are sterilised in a transfer isolator using peracetic acid vapour.
  • TRANSFER The transfer isolator is connected to the operating unit and the components transferred thereto.
  • COMPOUNDING Glucose solution (1000 ml) and electrolytes solution (1000 ml) is filled in EVA bags. The bags are sealed and the final product batch removed via a transfer isolator. (Visual control - Production)
  • the contents are combined in sterile EVA bags (5) under sterile conditions in a process isolator (4).
  • the following safety measures must be performed: the components containing the sterile solutions are counted and inspected visually, their surfaces sanitised and finally sterilised, e.g. in a portable glove isolator (3). Sterilisation of the surfaces is performed with vaporised peracetic acid.
  • the portable glove isolator is the joined to a so called "half suit isolator", in which the compounding is performed. This is a positive pressure type I isolator, e.g. a commercially available isolator from La Calhene, France.
  • the glove isolator is joined to the half suit isolator using a suitable air lock system, e.g. the so called DPTE system.
  • the glucose solution and the electrolytes solution are poured into sterile EVA bags.
  • additional solutions e.g. solutions containing nutritional components, are added. Air is removed from the bags, whereupon they are closed and sealed.
  • the bags can preferably be initially closed with plastic clips and later heat sealed.
  • the finished bag (6), containing a ready-to-use PD solution is removed from the process isolator (4) using the previously mentioned glove isolator (3) or other suitable air lock system (3')
  • the glucose and electrolytes solutions are controlled visually, chemically and microbiologically before released by Quality Control and transferred to the department where the compounding is performed.
  • the final PD solution should be clear and colourless or slightly yellowish and meeting the requirements of the European Pharmacopoeia (Ph.
  • Example 1 Preparation of a glucose solution
  • 50.0 g glucose monohydrate is mixed in 1000.0 ml water for injections (WFI), filtered (0.22 ⁇ m) and filled in glass bottles.
  • the WFI is controlled in-process and guaranteed to meet the following requirements: conductivity ⁇ 1.0 ⁇ S and pH 5.5 - 7.0.
  • the glucose solution is controlled in-process and guaranteed to meet the following requirements: glucose, optical rotation 98-105 %, pH 4.5-5.5.
  • the glass bottles are closed with rubber stoppers and sealed with aluminium caps prior to sterilisation. Sterilisation is performed as conventional steam sterilisation.
  • the volume in the vessels is continuously controlled and has to be in the interval of 1000 - 1100 ml.
  • the vessels are also inspected visually and the contents are required to be clear and free of visible particles.
  • the previously prepared glucose solution and electrolyte solution, packaged in 1000 ml bottles and sterilised is collected in equal volumes, in this case 1000 ml each.
  • a sterile EVA-bag with the volume 21 is reserved for the compounding. All items are rinsed and placed in a transfer isolator, where they are surface sterilised using peracetic acid vapour.
  • the transfer isolator is connected (DPTE) to a process isolator.
  • the containers containing the glucose and the electrolytes solution are opened and the contents poured into the EVA bag. Surplus air is removed from the bag which is closed first with a plastic clip, then heat sealed. The sealed containers are removed from the process isolator through a suitable air lock, maintaining the sterile conditions of the process isolator.
  • a first solution containing glucose, a second containing electrolytes and a third containing essential amino acids are transferred to a process isolator in unbroken packages.
  • the packages Before entering the process isolator, the packages are taken through an air lock, in which their surfaces are sterilised. The packages are then opened and the three solutions combined in EVA bags, as described in the previous example.
  • Example 5 Large scale production of PD-solution
  • the first and second solutions and optionally a third solution are sterilised in bulk containers, e.g. large stainless steel vessels (1 and 2 in fig. 3). Said vessels are before sterilisation equipped with closed conduits (1 ' and 2'). When the contents are sterilised, said conduits are brought to enter a process isolator (4) under sterile conditions. The outside of the conduits is sterilised before entry into the process isolator. Inside the process isolator, under sterile conditions, the conduits are opened and the solutions measured and mixed in EVA-bags (5), as described in the previous examples.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

L'invention concerne une solution physiologique stérile destinée à une dialyse pérotonéale préparée par association, dans des conditions aseptiques, d'au moins deux solutions. Cette solution physiologique contient une première solution de glucose stérile et une deuxième solution d'électrolytes stérile, toutes deux dans un volume et une concentration tels que le produit final soit à la fois physiologiquement acceptable et en conformité avec les exigences de pharmacopée relatives aux solutions destinées à la dialyse pérotonéale (solutions PD). Cette solution PD peut éventuellement contenir d'autres composantes nutritionnelles telles que les acides aminés.
PCT/SE1998/001831 1997-10-16 1998-10-12 Solution destinee a une dialyse perotoneale et son procede de production WO1999020249A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
AU96566/98A AU9656698A (en) 1997-10-16 1998-10-12 Solution for peritoneal dialysis and process for its manufacture
JP2000516649A JP2001520183A (ja) 1997-10-16 1998-10-12 腹膜透析用溶液及びその製造方法
EP98950558A EP1024789A1 (fr) 1997-10-16 1998-10-12 Solution destinee a une dialyse perotoneale et son procede de production
NO20002008A NO20002008L (no) 1997-10-16 2000-04-17 Løsning for peritonealdialyse og fremgangsmÕte for fremstilling derav

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE9703775-8 1997-10-16
SE9703775A SE9703775L (sv) 1997-10-16 1997-10-16 Framställning av sterial lösningar som innehåller glukos

Publications (1)

Publication Number Publication Date
WO1999020249A1 true WO1999020249A1 (fr) 1999-04-29

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PCT/SE1998/001831 WO1999020249A1 (fr) 1997-10-16 1998-10-12 Solution destinee a une dialyse perotoneale et son procede de production

Country Status (6)

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EP (1) EP1024789A1 (fr)
JP (1) JP2001520183A (fr)
AU (1) AU9656698A (fr)
NO (1) NO20002008L (fr)
SE (1) SE9703775L (fr)
WO (1) WO1999020249A1 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6743191B1 (en) 1999-04-26 2004-06-01 Edwards Lifesciences Ag Substitution infusion fluid and citrate anticoagulation
US7186420B2 (en) 1999-04-26 2007-03-06 Edwards Lifesciences Corporation Multi-part substitution infusion fluids and matching anticoagulants
US7208479B2 (en) 1998-12-04 2007-04-24 Baxter International, Inc. Peritoneal dialysis solution containing modified icodextrins
WO2010005961A3 (fr) * 2008-07-07 2010-05-06 Pentech Health, Inc. Compositions nutritives et leurs procédés d'utilisation
US8105258B2 (en) 1999-04-26 2012-01-31 Baxter International Inc. Citrate anticoagulation system for extracorporeal blood treatments
CN103751867A (zh) * 2014-01-20 2014-04-30 广州康盛生物科技有限公司 血液透析浓缩液及其制备方法
US8927505B2 (en) 2008-07-07 2015-01-06 Pentec Health, Inc. Nutritive compositions and methods of using same
WO2017109760A1 (fr) * 2015-12-24 2017-06-29 Ellen Medical Devices Pty Ltd Système de préparation de fluide de traitement
EP3482779A1 (fr) * 2013-06-25 2019-05-15 Fresenius Medical Care Deutschland GmbH Solution de dialyse

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006075195A (ja) * 2004-09-07 2006-03-23 Jms Co Ltd Ｌカルニチン含有腹膜透析液

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1982003773A1 (fr) * 1981-04-27 1982-11-11 Baxter Travenol Lab Solution de dialyse contenant du glucose, des acides amines et de l'insuline
WO1993009820A1 (fr) * 1991-11-18 1993-05-27 Gambro Ab Systeme utilisant une solution medicale sterile contenant des composes a base de glucose ou similaires et solution connexe
WO1997005852A1 (fr) * 1995-08-08 1997-02-20 Gambro Ab Sac destine a contenir une solution medicale sterile et procede de melange d'une solution medicale sterile

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1982003773A1 (fr) * 1981-04-27 1982-11-11 Baxter Travenol Lab Solution de dialyse contenant du glucose, des acides amines et de l'insuline
WO1993009820A1 (fr) * 1991-11-18 1993-05-27 Gambro Ab Systeme utilisant une solution medicale sterile contenant des composes a base de glucose ou similaires et solution connexe
WO1997005852A1 (fr) * 1995-08-08 1997-02-20 Gambro Ab Sac destine a contenir une solution medicale sterile et procede de melange d'une solution medicale sterile

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7208479B2 (en) 1998-12-04 2007-04-24 Baxter International, Inc. Peritoneal dialysis solution containing modified icodextrins
US8105258B2 (en) 1999-04-26 2012-01-31 Baxter International Inc. Citrate anticoagulation system for extracorporeal blood treatments
US7186420B2 (en) 1999-04-26 2007-03-06 Edwards Lifesciences Corporation Multi-part substitution infusion fluids and matching anticoagulants
US6743191B1 (en) 1999-04-26 2004-06-01 Edwards Lifesciences Ag Substitution infusion fluid and citrate anticoagulation
US7758900B2 (en) 1999-04-26 2010-07-20 Baxter International Inc. Multi-part substitution infusion fluids and matching anticoagulants
US9937125B2 (en) 2008-07-07 2018-04-10 Pentec Health, Inc. Intradialytic parenteral nutrition compositions
GB2473390A (en) * 2008-07-07 2011-03-09 Pentec Health Inc Nutritive compositions and methods of using same
GB2473390B (en) * 2008-07-07 2012-09-26 Pentec Health Inc Nutritive compositions and methods of using same
US8927505B2 (en) 2008-07-07 2015-01-06 Pentec Health, Inc. Nutritive compositions and methods of using same
US9326963B2 (en) 2008-07-07 2016-05-03 Pentec Health, Inc. Nutritive compositions and methods of using same
WO2010005961A3 (fr) * 2008-07-07 2010-05-06 Pentech Health, Inc. Compositions nutritives et leurs procédés d'utilisation
EP3482779A1 (fr) * 2013-06-25 2019-05-15 Fresenius Medical Care Deutschland GmbH Solution de dialyse
CN103751867A (zh) * 2014-01-20 2014-04-30 广州康盛生物科技有限公司 血液透析浓缩液及其制备方法
WO2017109760A1 (fr) * 2015-12-24 2017-06-29 Ellen Medical Devices Pty Ltd Système de préparation de fluide de traitement
US10850018B2 (en) 2015-12-24 2020-12-01 Ellen Medical Devices Pty Ltd. Treatment fluid preparation system
AU2016377318B2 (en) * 2015-12-24 2022-09-15 Ellen Medical Devices Pty Ltd Treatment fluid preparation system

Also Published As

Publication number Publication date
SE9703775L (sv) 1999-04-17
NO20002008D0 (no) 2000-04-17
EP1024789A1 (fr) 2000-08-09
JP2001520183A (ja) 2001-10-30
SE9703775D0 (sv) 1997-10-16
AU9656698A (en) 1999-05-10
NO20002008L (no) 2000-06-14

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