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WO1997004755A1 - Capsules en gelatine dures a faible niveau de transport d'eau et leur procede de fabrication - Google Patents

Capsules en gelatine dures a faible niveau de transport d'eau et leur procede de fabrication Download PDF

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Publication number
WO1997004755A1
WO1997004755A1 PCT/EP1996/003263 EP9603263W WO9704755A1 WO 1997004755 A1 WO1997004755 A1 WO 1997004755A1 EP 9603263 W EP9603263 W EP 9603263W WO 9704755 A1 WO9704755 A1 WO 9704755A1
Authority
WO
WIPO (PCT)
Prior art keywords
hard gelatin
gelatin capsule
capsules
capsule according
gelatin
Prior art date
Application number
PCT/EP1996/003263
Other languages
English (en)
Inventor
Dominique Cade
Xiongwei He
Original Assignee
Warner-Lambert Company
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 Warner-Lambert Company filed Critical Warner-Lambert Company
Priority to EP96926391A priority Critical patent/EP0841905A1/fr
Priority to JP9507217A priority patent/JPH11510148A/ja
Publication of WO1997004755A1 publication Critical patent/WO1997004755A1/fr

Links

Classifications

    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin

Definitions

  • the present invention is concerned with hard gelatin capsules with a low permeability to water vapour which reduce the sensitivity thereof to storage conditions and/or to hygroscopic fills and improves the protection of fills against atmospheric water vapour.
  • Hard gelatin capsules are widely used in the pharmaceutical industry as well as in the health food supplement market.
  • the main use thereof is as dosage form for solid preparation, i.e. active materials and excipients in powder form.
  • Capsules generally contain about 10 to 16% by weight of water. This water content is function of the relative humidity (RH) of the surroundings.
  • RH relative humidity
  • Another limitation is due to the high rate of water transport and/or high water vapor permeability through gelatin capsules shells. According to measurements which we have made at ambient temperature with a difference of 50% in the relative humidity across a gelatin film of 100 ⁇ m thickness, the weight of water vapor permeating through the film during a period of 24 hours is about twice the weight of the film itself. Consequently, when capsules exposed to an open environment, the fill will take up moisture from the environment by means of permeation and quickly attain a water content in equilibrium with the environment.
  • Both of the above gelatin characteristics can have an effect either on the capsules or on the fills or both.
  • Moisture changes in the capsules can have an effect on the mechanical stability of the gelatin capsules used as a container: if too humid, they become soft and may deform and if too dry, they may become brittle.
  • Moisture take-up by fills from capsules or more frequently from the environment by permeation may affect the properties of powder fills: they may agglomerate or, more seriously, degrade chemically for example by hydrolysis. Indeed, it is recommended to store most drugs in a dry environment.
  • Gelatin is by nature hygroscopic. It adsorbs water vapor, swells in water at low temperature and dissolves at high temperature.
  • S water solubility
  • D diffusion parameters
  • P high water vapor permeability
  • P SD.
  • the water contained in hard gelatin capsules is an element for the triple helix structure and acts as a most efficient plasticizer.
  • the hygroscopicity of gelatin and the moisture exchange between capsules and fills may be studied by sorption- desorption isotherms of gelatin capsules and fills. These studies are widely found in the literature, (see, in particular, K. Ito & al., Chem. Pharm. Bull.17 (3), 1969 1134-1137 and M.J. Kontny & al., Int. J. Pharm. 54, 1989, 79-85) . These authors report that, for a closed system, the final water content is intimately dependent upon the affinity of the various materials for water. Experimental equilibrium water content and relative humidity and estimated values calculated from the isotherms of these materials were in good agreement with each other.
  • a hard gelatin capsule with a reduced water vapour permeation through the hard gelatin capsule wherein either a polymer is laminated on to a hard gelatin shell and/or at least one additive is added to a gelatin formulation during the hard gelatin capsule production.
  • the present invention concerns hard gelatin capsules with a low water transport, these capsules being laminated or containing additives.
  • These capsules comprise a gelatin layer as base capsule material and a polymer layer with a low water permeability as barrier to the water transport.
  • capsules can be manufactured by double dipping moulding or by coating techniques.
  • Double dipping comprises dipping into a gelatin solution to form a gelatin layer and another dipping into a polymer solution to form a polymer layer.
  • a first dipping into a gelatin solution followed by a second dipping into a polymer solution after drying of the first layer gives a hard gelatin capsule with a polymer layer on the outside.
  • dipping first into a polymer solution followed by a dipping into a gelatin solution gives a hard gelatin capsule with a polymer layer on the inside.
  • the capsule coating comprises recovering of hard gelatin capsules with a polymer layer on the outside using conventional techniques for capsule or tablet coating.
  • the polymer layer is a polyvinyl alcohol which is water soluble, the solubility in water increasing as the molecular weight decreases.
  • polyvinyl alcohol is prepared from polyvinyl acetate by replacement of the acetate groups by hydroxyl groups.
  • the polymer used is to be understood to include not only polyvinyl alcohol but also polyvinyl acetate, as well as partly or wholly hydrolysed polyvinyl acetate, a degree of hydrolysis of more than 80% being preferred.
  • polyvinyl alcohols have degrees of hydrolysis of 98-99 mol % and of 87-89 mol %. Thus, they are partly saponified polyvinyl acetates with a residual content of acetyl groups of about 1 - 2 or 11 - 13 mol %, repectively.
  • co ⁇ polymers with, for example, ethylene and/or vinyl chloride.
  • the polymer used is hereinafter referred to as PVA.
  • PVA aqueous solution of PVA can be used for dipping and coating to produce the desired laminate which does not affect the capsule hydrosolubility.
  • PVA has good film formability and it can easily be made into a thin layer either by dipping or coating.
  • PVA has an extremely low water permeability which is more than 100 times lower than that of gelatin. Thus, PVA is a good barrier to water transport.
  • the molecular weight of the PVA used is preferably higher than 10000.
  • the PVA can be used in the form of a solution in water or in a solvent, an aqueous solution being preferred.
  • the thickness of the PVA layer is preferably from 1 to 50 % and more preferably 5 to 30 % of the total thickness of the capsule wall.
  • a setting agent such as SATIAGEL ME5 (Kappa carrageenan + KCI) supplied by Sanofi Bio-Industries can be added into PVA solution in order to attribute the solution a suitable setting ability.
  • the concentration of the setting agent is 0.05 % to 2 %, preferably 0.1 % to 0.8 %.
  • the gelatin contains, as additive, at least one polyol, which results in a significant reduction of the water vapour permeability.
  • this permeability decreases with the additive content and that the rupture or dissolving times of the capsules also decreases with increasing content of additive.
  • the polyols which can be used according to the present invention include sugars, sugar alcohols and other sugar substitutes, as well as polyvinyl alcohol, and structural analogues thereof.
  • Sugars which can be used according to the present invention include monosaccharides, namely, aldohexoses (for example glucose, mannose and galactose) , ketohexoses (for example fructose) and aldopentoses (for example arabinose, xylose and ribose) , as well as disaccharides (for example maltose, lactose and sucrose) .
  • aldohexoses for example glucose, mannose and galactose
  • ketohexoses for example fructose
  • aldopentoses for example arabinose, xylose and ribose
  • disaccharides for example maltose, lactose and sucrose
  • Sugar alcohols which can be used according to the present invention are polyols which can be obtained by the reduction of the carbonyl function of mono-saccharides. They include, for example, sorbitol, mannitol, lactitol, maltitol, glycerol, threitol, erythritol, adonitol, arabitol, xylitol, galactitol and structural analogues thereof.
  • sugar substitutes are to be understood to mean polyols which can be used nutritionally as replacements for sugars, for example lactitol, isomalt, hydrogenated glucose and maltose syrups and fructooligosaccharides.
  • the additives are incorporated into hard gelatin capsules by addition to a gelatin solution to be used for capsule manufacture. These additives are hydrosoluble and compatible with gelatin and the addition does not result in a significant change in the setting ability of the gelatin solution or in a detrimental change in the viscosity of the gelatin solution. Consequently, capsules containing these additives can be manufactured by conventional dip moulding process under standard conditions.
  • the amount of the additive content in the gelatin can be from 1 to 50 %, preferably 5 to 40 % or and more preferably from 10 to 30 %.
  • the gelatin capsules according to the present invention can contain one or more of the additives.
  • the gelatin used for the production of capsules according to the present invention can be coloured with dyes and/or pigments, can contain opacifiers, preservatives and plasticisers. Substances can also be added to aid the manufacturing process and also to aid the subsequent performance of the capsules.
  • synthetic water-soluble dyes such as azo, indigoid, quinophthalone, triphenylmethane and xanthene dyes
  • certain dyes of natural origin for example carotenoids and flavones
  • pigments for example titanium dioxide which acts as an opacifying agent, carbon and iron oxides.
  • gelatin is a good medium for bacterial and fungal growth, it is advisable to add to the gelatin one or more bactericidal, bacteriostatic and fungicidal agents, usually in a concentration of up to 0.2 % w/w.
  • One preferred combination for this purpose contains methyl and propyl hydroxybenzoates in a ratio of 4:1.
  • the use of certain non-toxic organic acids, for example benzoic. propionic and sorbic acids, preferably in the form of a water-soluble salt, provides a protection against moulds and yeasts and also imparts bacteriostatic properties. They are usually employed in concentrations of up to 1 % w/w.
  • plasticisers for the production of the capsules, the use of plasticisers, lubricants and colouring agents of pharmaceutical quality leads to optimum product qualities.
  • Plasticisers such as polyethylene glycol, or preferably low molecular weight organic plasticisers, such as glycerol, dioctyl sodium sulphosuccinate, triethyl citrate, tributyl citrate, 1,2- propyleneglycol, mono-, di- or triacetates of glycerol and the like, are used in various concentrations of about 0.5 to 40 % and preferably of 0.5 to 10 %, based on the weight of the polymer.
  • plasticisers such as polyethylene glycol, or preferably low molecular weight organic plasticisers, such as glycerol, dioctyl sodium sulphosuccinate, triethyl citrate, tributyl citrate, 1,2- propyleneglycol, mono-, di- or triacetates of glycerol and the like.
  • Pharmacologically acceptable lubricants such as sodium lauryl sulfate, the stearates of aluminium, calcium, magnesium and tin, as well as talc, silicones and the like, can be used in concentrations of about 0.1 to 10 % and preferably of 0.1 to 5 %, referred to the weight of the polymer.
  • compositions for the production of aesthetic effects, for identification purposes, for psychological effects on patients and also for light protection, pharmaceutically acceptable colouring agents, such as azo dyes, and other dyestuffs and pigments, such as iron oxides, titanium dioxide, natural dyes and the like, are used in concentrations of about 0.001 to 10 % and preferably of 0.001 to 5 %, referred to the weight of the polymer.
  • capsules according to the present invention can be produced with various grades of gelatin combined with 5 to 95 % by weight of extenders, such as sunflower proteins, soya bean proteins, cotton seed proteins, peanut proteins, rape seed proteins, lactose, gum arabic, acrylates and methacrylates, water- soluble derivatives of cellulose, such as cellulose acetyl phthalate (CAP) , hydroxy-propylcellulose, hydroxypropyImethylcellulose, hydroxy-propylmethyl cellulose phthalate (HPMCP) , hydroxy-methylcellulose, polyvinylpyrrolidone, shellac, bentonite, polyvinyl acetate phthalate, phthalated gelatin, succinated gelatin and polysaccharides, such as agar-agar.
  • extenders such as sunflower proteins, soya bean proteins, cotton seed proteins, peanut proteins, rape seed proteins, lactose, gum arabic, acrylates and methacrylates
  • water- soluble derivatives of cellulose such as
  • the capsules according to the present invention can be used as containers especially for the exact dosing of nutrients, medicaments, chemicals, colouring materials, spices, fertilizer combinations, seeds and seed materials, cosmetics and agricultural products.
  • the capsules can be used as containers for hygroscopic materials and for inhalation agents. They can also be used as matrices of the most varied forms and sizes for nutrients, medicaments, chemicals, colouring materials, spices, fertilizer combinations, seeds and seed materials, cosmetics and agricultural products.
  • the capsules according to the present invention can also contain tablets or so-called caplets (tablets pressed in capsule form) , as well as with special forms, for example microdispersions within the matrix which are liberated from the matrix by breakdown and/or dissolving and/or bioerosion and/or diffusion and consequently be liberation-controlled systems for the administration of the enclosed substances.
  • the capsules can be filled with medicinal or surgical products formed from appropriate masses or foams thereof.
  • the water vapor permeability of capsules is evaluated by the moisture uptake kinetics of a hygroscopic powder filled into the capsules.
  • Capsules were first equilibrated at 22°C/50% relative humidity, the hygroscopic powder used being the sodium salt of carboxymethyl-cellulose (CMC) , with high viscosity (from Sigma) .
  • the CMC which has an equilibrium water content of about 16 % at 22°C/50% relative humidity was previously dried at 105°C to reduce the water content thereof to zero.
  • the capsules are stored at 22°C/50% relative humidity and the weight thereof was monitored from time to time in order to determine the take-up of moisture by the CMC.
  • the CMC water content was calculated from the weight increase of the filled capsules. Taking into account the mean wall thickness of the capsules and the initial dry CMC weight, a mathematical determination of the comparative permeability of different capsules can be carried out from the CMC moisture uptake kinetics.
  • the water vapor permeability of films was determined under stable permeation at 22°C by means of a permeation cell. This cell had a permeation window covered with the film to be tested. Filling the cell with freshly regenerated silica gel (from Prolabo) and storing at
  • the permeability is calculated from:
  • the PVA solution obtained was introduced into the dipping dish of a pilot dipping machine, the solution temperature being maintained at 55°C.
  • a first dipping into the PVA solution with pins of hard capsule size No. 1 was carried out in the conventional way.
  • a second dipping into a gelatin solution, made with a mixture of pharmaceutical grade gelatins of types A and B with Bloom above 200 g, according to conventional methods gave capsules internally laminated with PVA which were tested for water vapor permeability with reference to conventional hard gelatin capsules by using the above- described test for the water vapour permeability of capsules.
  • a PVA solution was prepared as in Example 1.
  • the dish temperature of the PVA solution was maintained at 45°C.
  • a first dipping into the PVA solution and a second dipping into the gelatin solution were carried out as in Example 1 to give capsules internally laminated with PVA.
  • a PVA solution was prepared as in Example 1.
  • the dish temperature of the PVA solution was maintained at 45°C.
  • a first dipping into the gelatin solution and a second dipping into the PVA solution gave capsules externally laminated with PVA.
  • the properties of gelatin films with additive were first studied.
  • the gelatin films were cast from a 27% (w/w) gelatin solution containing various additives with contents from 0 % to 30 % [w(additive) /w(gelatin) ] . Films were dried under atmospheric conditions (22°C/50% relative humidity) for 24 hours and evaluated for the water vapor permeability, hygroscopicity and dissolution thereof.
  • Table 7 Table 7
  • Gelatin films with a mixture of additives (sorbitol + mannitol) of 20% were cast and tested as described in Example 4.
  • Capsules mean weight (mg) 76 74 75 comparative permeability 100 20 11
  • Capsules mean weight (mg) 76 75 78 comparative permeability 100 49 23

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Abstract

La présente invention se rapporte à une capsule en gélatine dure ayant un niveau de transport d'eau réduit ou ayant une faible pénétration de vapeur d'eau à travers la capsule en gélatine dure, dans laquelle une couche de polymère est laminée sur une coque de gélatine dure, et/ou au moins un additif est ajouté à la formulation de gélatine au cours de la production de la capsule de gélatine dure.
PCT/EP1996/003263 1995-08-02 1996-07-24 Capsules en gelatine dures a faible niveau de transport d'eau et leur procede de fabrication WO1997004755A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP96926391A EP0841905A1 (fr) 1995-08-02 1996-07-24 Capsules en gelatine dures a faible niveau de transport d'eau et leur procede de fabrication
JP9507217A JPH11510148A (ja) 1995-08-02 1996-07-24 水分輸送が低い硬ゼラチンカプセル及びその製造方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR95/09412 1995-08-02
FR9509412 1995-08-02

Publications (1)

Publication Number Publication Date
WO1997004755A1 true WO1997004755A1 (fr) 1997-02-13

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PCT/EP1996/003263 WO1997004755A1 (fr) 1995-08-02 1996-07-24 Capsules en gelatine dures a faible niveau de transport d'eau et leur procede de fabrication

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EP (1) EP0841905A1 (fr)
JP (1) JPH11510148A (fr)
WO (1) WO1997004755A1 (fr)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999046329A1 (fr) * 1998-03-11 1999-09-16 Warner-Lambert Company Compositions a base d'alcool polyvinylique
FR2775979A1 (fr) * 1998-03-11 1999-09-17 Warner Lambert Co Compositions filmogenes a base d'alcool polyvinylique
WO2001001797A1 (fr) * 1999-06-30 2001-01-11 Meduna Arzneimittel Gmbh Forme galenique orale
WO2002041711A1 (fr) * 2000-11-24 2002-05-30 Unilever N.V. Produit alimentaire contenant des carotenoides
EP1498117A1 (fr) * 2003-07-15 2005-01-19 Pfizer GmbH Arzneimittelwerk Gödecke Capsule en gélatine ou composition de capsules contenant de la gélatine à stabilité améliorée, procédé de préparation de capsules et procédé pour améliorer la stabilité de capsules en gélatine
US7264824B1 (en) 2000-04-13 2007-09-04 Meduna Arzneimittel Gmbh Oral dosage form
US7682814B2 (en) 2003-12-11 2010-03-23 Cj Cheiljedang Corp. Method for producing lactic acid with high concentration and high yield using lactic acid bacteria
US8728521B2 (en) 2005-12-27 2014-05-20 Hemant N. Joshi Physically/molecularly distributed and/or chemically bound medicaments in empty, hard capsule shells
US20210369627A1 (en) * 2018-10-02 2021-12-02 Qualicaps Co., Ltd. Improved-strength hard capsule and production method for same
US11318101B2 (en) 2016-07-06 2022-05-03 Qualicaps Co., Ltd. Hard capsule having improved hardness, and method for manufacturing same

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2707906A1 (fr) * 2007-12-05 2009-06-18 Novartis Ag Receptacle pour formulation pharmaceutique pulverisable en aerosol
WO2015060313A1 (fr) * 2013-10-22 2015-04-30 森下仁丹株式会社 Préparation ayant une capacité de libération contrôlée et son procédé de production

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3467748A (en) * 1963-01-05 1969-09-16 Scherer Gmbh R P Coated gelatin capsules
EP0180287A2 (fr) * 1984-10-23 1986-05-07 Shin-Etsu Chemical Co., Ltd. Composition à base d'éther de cellulose et capsule dure et médicale préparée à partir de cette composition
US4816259A (en) * 1987-02-12 1989-03-28 Chase Chemical Company, L.P. Process for coating gelatin capsules
JPH0422835A (ja) * 1990-05-16 1992-01-27 Toyo Alum Kk 密封包装体の密封性検査方法

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3467748A (en) * 1963-01-05 1969-09-16 Scherer Gmbh R P Coated gelatin capsules
EP0180287A2 (fr) * 1984-10-23 1986-05-07 Shin-Etsu Chemical Co., Ltd. Composition à base d'éther de cellulose et capsule dure et médicale préparée à partir de cette composition
US4816259A (en) * 1987-02-12 1989-03-28 Chase Chemical Company, L.P. Process for coating gelatin capsules
JPH0422835A (ja) * 1990-05-16 1992-01-27 Toyo Alum Kk 密封包装体の密封性検査方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Week 6800, Derwent World Patents Index; AN 67-07975h, XP002015474 *

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999046329A1 (fr) * 1998-03-11 1999-09-16 Warner-Lambert Company Compositions a base d'alcool polyvinylique
FR2775979A1 (fr) * 1998-03-11 1999-09-17 Warner Lambert Co Compositions filmogenes a base d'alcool polyvinylique
US7045184B2 (en) 1998-03-11 2006-05-16 Warner-Lambert Company Polyvinyl alcohol compositions
WO2001001797A1 (fr) * 1999-06-30 2001-01-11 Meduna Arzneimittel Gmbh Forme galenique orale
US7264824B1 (en) 2000-04-13 2007-09-04 Meduna Arzneimittel Gmbh Oral dosage form
WO2002041711A1 (fr) * 2000-11-24 2002-05-30 Unilever N.V. Produit alimentaire contenant des carotenoides
EP1498117A1 (fr) * 2003-07-15 2005-01-19 Pfizer GmbH Arzneimittelwerk Gödecke Capsule en gélatine ou composition de capsules contenant de la gélatine à stabilité améliorée, procédé de préparation de capsules et procédé pour améliorer la stabilité de capsules en gélatine
US7682814B2 (en) 2003-12-11 2010-03-23 Cj Cheiljedang Corp. Method for producing lactic acid with high concentration and high yield using lactic acid bacteria
US8728521B2 (en) 2005-12-27 2014-05-20 Hemant N. Joshi Physically/molecularly distributed and/or chemically bound medicaments in empty, hard capsule shells
US11318101B2 (en) 2016-07-06 2022-05-03 Qualicaps Co., Ltd. Hard capsule having improved hardness, and method for manufacturing same
US20210369627A1 (en) * 2018-10-02 2021-12-02 Qualicaps Co., Ltd. Improved-strength hard capsule and production method for same

Also Published As

Publication number Publication date
JPH11510148A (ja) 1999-09-07
EP0841905A1 (fr) 1998-05-20

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