SK164897A3 - Methods and compositions for preparing soft gelatin capsules having shells resistant to permeation by fill materials - Google Patents

Abstract

Disclosed are gelatin capsules having a means for isolating the fill material from the gelatin material forming the shell of the capsule.

Description

A gelatin capsule, a method for making it, a method of preventing migration from a fill material and a composite film

Technical field

The present invention relates to the field of gelatin capsules comprising a filling material comprising a liquid phase. More specifically, the present invention relates to gelatin capsules comprising a gelatin sheath providing impermeability to the fill material in the gelatin sheath.

BACKGROUND OF THE INVENTION

Soft gelatin capsules or soft gels are mainly used to contain liquids, the active ingredients being present in dissolved or suspended state. The liquids used as part of the filler materials typically include vegetable oils, animal oils, mineral oils, liquid hydrocarbons, essential oils, polyethylene glycol. Fats and waxes are also commonly used or added to the fill to modify its consistency. In addition, the soft gelatin capsule fill material may contain a maximum of about 8% water by weight.

However, certain liquid materials migrate to and / or interact with the gelatin forming the capsule shell. This migration or interaction has a detrimental effect on the stability and structure of the gelatin capsule. E.g. water, a solvent for gelatin-forming protein material, dissolves gelatin. Filling materials for gelatin capsules can only be prepared containing up to about 8% water by weight. Similar problems arise when using other liquids in fill materials for gelatin capsules. Polyethylene glycol, ethanol, propylene glycol and similar low molecular weight polar solvents also interact undesirably with the gelatin shell. These problems are described in U.S. Pat. 4888239 and 4780316. It should be noted that the problems associated with these liquids are not merely attributed to the migration of the liquid into the housing. Certain liquids, e.g. polyethylene glycol are hygroscopic and tend to absorb plasticizers from the encapsulating material, causing the sleeve to become brittle.

As a result, there is a need to prepare gelatin capsules that will be substantially resistant to migration of liquid fill materials into the gelatin capsule, and thus the gelatin capsule will obtain a predetermined stability. Further, there is a need to prevent the migration of components from the housing to the fill material.

SUMMARY OF THE INVENTION

The invention encompasses gelatin capsules having a barrier that effectively isolates the gelatin shell and its constituents from the fill material. The invention thus provides gelatin capsules comprising a multilayer housing having an outer layer and at least one inner layer that acts as a barrier. The multilayer housing accommodates a packing material that contains a hydrophilic or hydrophobic component. The outer layer of the gelatin capsule typically comprises gelatin, while the barrier (in some cases the layer in contact with the cartridge) is made of a material resistant to the migration of hydrophilic or hydrophobic components from the filler material to the outer layer. Included within the scope of the invention are a number of combinations of the outer gelatin layer adhered to other layers that contain a barrier.

Thus, the invention provides gelatin capsules capable of containing a filler material containing more than 8% by weight of water. The resulting gelatin capsules, which contain water, have excellent long-term stability and are capable of encapsulating a variety of liquid fill materials. The invention further encompasses gelatin capsules capable of containing a fill material having a tendency to absorb water or other shell materials without any of the shell components being absorbed by the cartridge.

The resulting gelatin capsules can be prepared to contain various solutions, lotions, emulsions, creams, gels or suspensions.

The invention further provides gelatin capsules capable of encapsulating the filling material / whose various components may adversely affect the physical or chemical stability of the gelatin capsule shell. The filler material may comprise pharmaceuticals such as synthetic drugs and proteins, various antibodies and enzymes and vitamins and minerals, fine chemicals, industrial chemicals, solvents, insecticides, etc.

The invention further provides a method of making gelatin capsules, wherein the gelatin capsules are capable of containing a liquid filling material which is also capable of adversely interacting with the gelatin shell. The method comprises making a gelatin tape, wherein the gelatin tape has an outer layer comprising gelatin and an inner layer resistant to migration of hydrophilic and hydrophobic materials; providing a filler material comprising a system comprising a liquid that can interact undesirably with gelatin; and encapsulating the fill material in a gelatin tape using a rotary encapsulation device. The invention also provides composite films comprising a gelatin layer and a barrier layer, wherein the barrier layer is resistant or impermeable to the migration of hydrophilic and hydrophobic materials through the barrier.

A composite film, i. The multilayer gelatin tapes prepared according to the invention to have a gelatin layer and at least one barrier layer can also be used as boards for packaging or various products.

Description of the figures in the attached drawings

Fig. 1 is a cross-section of a head having a configuration of a single slot coated arm cavity having an opening 2 and an edge of a punch 1;

Fig. 2 is a cross-section of a coextrusion delivery head having openings 4, 4a and 4b and an outlet opening 3;

Fig. 3 is a cross-section of a multi-slot multi-outlet head having openings 5, 5a and 5b and an edge of the head 6; and FIG. 4 and 5 are cross-sectional views of various single-output heads that include openings 7, 7a and 7b and an edge of the head 13.

DETAILED DESCRIPTION OF THE INVENTION

The gelatin capsules of the invention comprise a capsule and a filling material disposed in the capsule. The housing comprises at least one outer layer and at least one inner layer that acts as a barrier layer. The outer layer typically comprises gelatin, while the barrier layer is formed of a material that is resistant to permeation by the material that forms the filler material. Thus, the housing comprises a barrier layer as an inner layer that prevents liquid material from migrating from the cartridge into the outer gelatin layer. The barrier layer may be adjacent to the filler material and be in contact with the filler material, or may be insulated from the filler material by an inserted layer of gelatin or other material. Further, the barrier layer may comprise a plurality of layers of material impermeable or resistant to permeation by the filler material.

The filler material comprises any of a plurality of liquid components in addition to various solid materials. The liquid may be a hydrophilic liquid or it may be a hydrophobic, ie lipophilic, liquid. Representative hydrophilic ingredients include water, C 1 -C ₃ -alcohols, polyethylene glycols, glycerol, propylene glycol, C 1 -C ₄ acids, saturated polyglycolyzed C ₈ -C ₁₀ glycerides, glycofural, diethylene glycol monoethyl ether, highfructose corn syrup, maltose, maltose, maltose , honey and sorbitol.

Representative hydrophobic or lipophilic components include hydrocarbons such as, for example, mineral oils, petrolatum, polyethylene waxes and microcrystalline waxes, as well as zopropylmiristate; vegetable oils, alcohols with long synthetic esters such as, for example, natural esters such as, for example, animal fats and lanolin; natural chain; synthetic chain alcohols; long chain natural fatty acids; long chain synthetic fatty acids; ethers such as polyoxyethylenes; silicones such as, for example, substituted or unsubstituted silicones; mixed vegetable waxes such as candelilla; mixed animal waxes such as beeswax; or mixtures of any of these components.

As mentioned above, the housing comprises an outer layer and at least one barrier layer where the inner layer may be in contact with the capsule fill material. These layers are separate layers, which are preferably mixed on their contact surfaces to improve the adherence between the layers. The invention includes various combinations of the outer gelatin layer and the inner layers, wherein at least one inner layer is a barrier layer. Other inner layers may be made of gelatin or other suitable material such as, for example, agar, pectin, alginate, starch, carrageenin, cellulose or similar polysaccharides or other film-forming polymers such as shellac or whey protein. The capsule shell is a multilayer composite of the outer layer and the at least one inner layer. The composite may be a two-layer, three-layer or four-layer housing. Optionally, the sheath may be a multilayer composite having more than four layers. The individual properties of the desired end product can be varied using such combinations. Examples of these alternative combinations are as follows:

outer layer inner layers

gelatine: barrier gelatine: barrier barrier gelatine: barrier gelatin gelatine: gelatin barrier gelatine: barrier gelatin : barrier gelatine: barrier agar : barrier gelatine: esar gelatin : barrier

Ί

The multilayer tapes for use according to the invention have a thickness of from about 0.01 to 0.07, preferably from about 0.02 to 0.05, and more preferably from about 0.03 to 0.035 inches.

The layer in contact with the filler material may be a gelatin layer, optionally modified as described below, to protect and isolate the barrier layer during the manufacture of the tape and the final gelatin capsule. The gelatin layer may be a protective or lubricating layer that isolates the sticky barrier from the encapsulation device.

The outer layer comprises gelatin and a plasticizer for gelatin. The gelatin mass used to prepare the capsule shell is made by conventional methods using traditional ingredients. The gelatin may optionally comprise a brittleness inhibiting composition comprising materials such as a mixture of sorbitol and one or more sorbitans. See U.S. Pat. Further, the gelatin optionally comprises a sticky or viscosity modifier. Examples of tackifiers and viscosity modifiers are ethylene-acrylic acid amylose copolymer.

A preferred gelatin outer layer comprises gelatin, glycerin as a plasticizer and water. In preferred embodiments of the dry finished capsule of the invention, the gelatin present in the outer layer is about 40 to 70% by weight of the outer layer; glycerin from about 20 to 40% by weight of the outer layer; and water of about 5 to 15% by weight of the outer layer.

When the layer in contact with the fill material is a gelatin layer, then the gelatin layer may optionally be modified by the addition of hydrophobic components. Representative suitable hydrophobic components include colloidal silicas, modified silicas, modified silicones, magnesium stearate, oxidized polyethylene homopolymer, polyethylene homopolymer, paraffin wax or mixtures of these materials.

The barrier layer of the capsule comprises any of a variety of homopolymers or copolymers. Such polymers may be obtained from the polymerization of a monomer selected from the group consisting of acrylamide, acrylic acid, acrylonitrile, caprolactones, ethylene, furan, maleic anhydride, methacrylate, methacrylic acid, methacrylate, methylpropene, styrene, vinyl acetate, vinyl alcohol, vinyl ether, vinyl chloride, vinyl chloride, vinyl chloride, salts of any of the above acids or mixtures of these materials. The inner layer may also comprise paraffin wax. The barrier layer may further comprise hydrocarbons such as polyethylene waxes or microcrystalline waxes, synthetic esters such as isopropylmiristate, natural esters such as vegetable oils, animal fats or lanolin, long chain natural alcohols, long chain synthetic alcohols, long chain natural fatty acids , long chain synthetic fatty acids, ethers such as polyoxypropylenes, silicones, mixed vegetable waxes, mixed animal waxes such as beeswax or mixtures thereof. By microcrystalline wax is meant a solid mixture of hydrocarbons having from 18 to 36 carbon atoms. Such solid hydrocarbons have molecular weights from about 490 to 800 and viscosities from about 45 to 120 Saybolt Universal Seconds (SUS) at 99 ° C (210 ° F).

Preferred inner shell layers comprise paraffin waxes, polyethylene homopolymers or polyethylene copolymers. A particularly preferred inner layer comprises an ethylene-acrylic acid copolymer available from Allied Signal, Inc., Morristown, N.J. and microcrystalline wax from

Witco Corporation, Greenwich, CT. In particularly preferred capsule inner layers according to the invention, the ethylene-acrylic acid copolymer is about 50 to 90% by weight of the inner layer and microcrystalline wax is about 10 to 50% by weight of the inner layer. Other preferred layers have the following compositions:

barrier layer composition% w / w supplier (s) of components ethylene-copolymer 70 Allied Signal, Inc.

acrylic acid,

A-C5180 microcrystalline wax 30

Witco Corp .; or Petrolite Corp.

The housing is formed in such a way that each layer adheres securely to each other layer. For example, in a bilayer capsule shell, the gelatin layer, i. the outer layer, adheres to the inner layer, i. to the barrier layer.

The sleeve according to the invention is prepared from a multilayer, e.g. a two-layer or three-layer tape that contains materials that allow processing into a soft gelatin capsule on a rotary compression encapsulation device without laminating or separating the various layers of the multi-layer tape. A satisfactory adhesion is defined as interlayer adhesion sufficient to prevent separation or delamination during all stages of the encapsulation process.

The barrier layer material is selected to be impermeable to hydrophilic materials such as water, polyethylene glycols, glycorol, propylene glycol, various C1-C3 alcohols, etc. The barrier layer must also be impermeable to a number of different hydrophilic or lipophilic vehicles such as fractionated coconut oil, light mineral oil, petrolatum, etc. The materials that make up the housing must act as a homogeneous single tape of the housing material, i. the materials must exhibit properties similar to those of a typical gelatin tape. Each inner layer that includes a barrier layer, when adhered to the outer layer, must have sufficient elasticity, strength and heat-sealable capabilities to allow processing of the multilayer material into capsules on a rotary encapsulating device.

Adhesion of each layer to another layer, e.g. the barrier layer to the gelatin layer may be increased by including tackifiers in the composition of the gelatin mass, or the inner layer or barrier layer, or each layer material; alternatively, it can be increased by physically modifying the layers during the manufacturing process. Examples of tackifiers and viscosity modifiers include ethylene-acrylic acid copolymer and amylose.

In order to obtain a suitable material for preparing a multilayer sheath of gelatin and at least one barrier material, the gelatin mass or barrier material may be modified by the addition of viscosity modifiers in either the gelatin composition or the barrier fill. Alternatively, the rheological characteristics of these materials can be modified by physically altering the manufacturing process. There are a number of methods for preparing multilayer tapes suitable for use in the preparation of gelatin capsules. The gelatin capsule preparation devices are rotary mold encapsulation devices modified such that the inner and outer layers of the capsule shell are made simultaneously by coextrusion into a molding roll using a coextrusion feeder block and a single-slot, single-output plate head.

Preferred embodiments include machines modified such that the inner and outer layers are coextruded into the molding roll using a multi-slot, multi-outlet plate head. Another alternative involves preparing the inner and outer layers successively by extrusion into a molding roll using a single-slot, single-output crevice slot head. Typically, the gelatin tape is shaped while coextruding the inner and outer layers into a forming roller.

Extrusion heads suitable for preparing the multilayer films of the invention are typically capable of 1) force-processing molten gelatin and barrier materials into thin films, 2) keeping the molten materials at a constant temperature; and 3) dispensing molten material at a constant pressure and rate into the head region to prepare a uniform thickness film. Examples of extrusion heads suitable for use in the invention include those shown in the following table:

extrusion head type single-slot single-output (shoulder slot configuration) multi-slot single-output multi-slot multi-output coextrusion feed block & head manufacturer Extrusion Dies, Inc.,

Chippewa Falls, WI Killion Extruders, Inc.

Cedar Grove, NJ Liberty Tool Corp.

Rochester, NY Extrusion Dies, Inc.

Chippewa Falls, WI Liberty Tool Corp.

Rochester, NY

Randcastle Extrusion Systems Inc., Cedar Grove, NJ The Cloeren Company,

Orange, TX

In the coextrusion feeder system, the coextrusion feeder as shown in FIG. 2 mounted on a shoulder type head, as shown in FIG. 1 so that the outlet orifice 3 is adjacent to the feed orifice 2. The coextrusion feeder and head are mounted so as to abut the forming roll to provide the roll with a film of material.

In the heads shown in Figures 1, 3, 4, and 5, the edge openings of the head provide a single-layer, two-layer, or multi-layer material, depending on the configuration. The head is mounted on the rotary head encapsulation device such that the edges of the head abut the forming roll and provide the forming roll with a thin film of material.

Other methods that can be used to prepare the multilayer tape include:

1) spraying homogeneous coating layers of the coating material onto the substrate layer;

2) laminating the preformed layer into a substrate layer; and

3) applying a coating layer to the substrate using a transfer roller system.

The following examples illustrate the practice of the invention.

DETAILED DESCRIPTION OF THE INVENTION

Example 1

Two-layer soft gelatin capsules are made on a rotary encapsulating device using the materials listed in Table I. The two-layer (gelatin-barrier) tapes are made by coextrusion technique. These two-layer tapes are shaped using a multi-slot multi-output head.

Table I

Housing composition of bilayer soft gelatin capsules Soft capsule layer Dry capsule composition% w / w component

outer layer of gelatin, NF (150 43

Glycerine, USP 20 purified water, 8

USP inner layer copolymer ethylene-20 acrylic acid (A-C5180) microcrystalline wax

Formulation 1: PEG 400 solution containing 20% w / w.

The water was encapsulated in a bilayer capsule composition described in Table I. Soft gelatin capsules having a good seal were obtained.

Formulation 2: PEG 400 solution containing 40% w / w.

The water was encapsulated in a bilayer capsule composition described in Table I. Soft gelatin capsules having a good seal were obtained.

Formulation 3:

It was prepared by a pouch composition containing 100%. They were obtained by a soft seal.

bilayer capsule as described in Table I, purified water as a filling, gelatin capsule with good

Formulation 4: A bilayer capsule composition as described in Table I was prepared containing a water-in-oil ointment filling containing about 25 wt. water. Soft gelatin capsules with good sealing were obtained using a rotary encapsulating device.

Formulation 5: A hydroalcoholic solution containing 35% w / w. water, 5% w / w. propylene glycol and 60% w / w. The alcohol was encapsulated in a bilayer capsule having the capsule composition described in Table I.

Soft gelatin capsules with good seal were obtained.

statement

statement

Formulation>: Oil in water emulsion cream containing 68% w / w. water, 6% w / w. cetaryl alcohol, 6% w / w. cetyl ester wax, 2.5% w / w sorbitan monostearate, 2.5% w / w. polysorbate 60, 13% w / w octyldodecanol and 2% w / w. benzyl alcohol was encapsulated in a bilayer capsule having the composition of the capsule described in the table

I. Soft gelatin capsules with good seal were obtained.

Water-in-oil emulsion containing 56.3% w / w. water, 10% w / w. POE of glycerol sorbitan, isostearate, 3% w / w. beeswax, 3% w / w. lanolin, 11% w / w. of caprylic / carp triglyceride, 11% w / w. squalane, 3% w / w. sunflower oil, 2% w / w. glycerin and 0.7% w / w. magnesium sulfate was encapsulated in a bilayer capsule having the capsule composition described in Table I. Soft gelatin capsules having a good seal were obtained.

: Clear softening gel, w / w. ethanol, hydroxypropylcellulose and ethoxydiglycol contained 58% 1% w / w. 41% w / w encapsulated in a bilayer capsule having the capsule composition described in Table I.

Example 2

Bilayer and gelatin-barrier composite tapes are prepared comprising a barrier layer comprising a 70:30 mixture of ethylene-acrylic acid copolymer and microcrystalline wax, wherein the gelatin and barrier layers are between 0.019 and 0.033 inches thick. For comparison, a 0.032 inch thick gelatin layer was prepared using conventional gelatin strip casting methods. The water vapor permeation rates for each strip are shown in Tables II and III below.

Table II

Water vapor permeation through double-layer tape at 23% relative humidity and 25 ° C time (hours) water loss (% w / w / cm*)

41 0,291 48 0, 311 120 0,394 216 0, 423 360 0, 476 456 0, 493 1488 0,502

Table III

Water vapor permeation through gelatin tape at 23% relative humidity and 25 ° C time (hours) water loss (% w / w / cm ')

48 14 • 96 33 168 87 336 100

However, many other embodiments not specifically described herein may fall within the spirit and spirit of the present invention and claims.

Claims (28)

PATENT CLAIMS 1. A gelatin capsule produced by a rotary head method comprising: (a) a housing having an outer layer and a barrier layer and [a] on at least one barrier layer; and (b) a pumpable packing material disposed within the housing, wherein the barrier layer is disposed between the outer layer and the packing material; wherein the filler material comprises a hydrophilic component, a hydrophobic component, an amphiphilic component, or mixtures thereof; the outer layer comprises gelatin and the barrier layer is resistant to migration of hydrophilic, amphiphilic and hydrophobic components from the filler material into the outer layer. The gelatin capsule of claim 1, wherein the barrier layer is adhered to the outer layer. The gelatin capsule of claim 1, wherein the aqueous component is water, or C 1 -C 3 alcohols, polyethylene glycol, glycerol or propylene glycol. The gelatin capsule of claim 1, wherein the hydrophobic component is an oil. The gelatin capsule of claim 1, wherein the barrier layer comprises paraffin wax, polyethylene homopolymer, polyethylene copolymer, polymer obtained from the polymerization of a monomer selected from the group consisting of acrylamide, acrylic acid, acrylonitrile, caprolactones, ethylene hydrate, acrylic acid, maleic acid, maleicin , methacrylate, methylpropylene, styrene, vinyl acetate, vinyl alcohol, vinyl chloride, vinylethyl ether, vinyl propyl ether, vinyl pyrrolidone, salts or mixtures thereof, hydrocarbon, polyethylene wax, microcrystalline waxes, synthetic esters, natural esters, natural long chain alcohols, synthetic alcohols with long long chain acids, long chain, ether or mixtures thereof. chain, synthetic natural fatty fatty of 6. A gelatin capsule according to Claim 1 where external the gelatin layer comprises a sticky modified gelatin. The gelatin capsule of claim 1, wherein the barrier layer comprises a sticky substance. The gelatin capsule of claim 6, wherein the outer layer further comprises a viscosity modifier. The gelatin capsule of claim 7, wherein the barrier layer further comprises a viscosity modifier. The gelatin capsule of claim 1, wherein the barrier layer comprises an ethylene-acrylic acid copolymer and a microcrystalline wax. The gelatin capsule of claim 1, wherein the filler material comprises a solvent system comprising up to about 100% water. A method of making a gelatin capsule capable of supporting a filler material comprising up to about 100% water, comprising: (a) forming a gelatin tape, wherein the gelatin tape has an outer layer comprising gelatin and a barrier layer resistant to migration of hydrophilic or hydrophobic materials; (b) preparing a filler material comprising a solvent system comprising up to about 100% by weight of water in the solvent system; and (c) encapsulating the filler material in a gelatin ribbon using a rotary-head encapsulation device. The method of claim 12, wherein the formation of a gelatin tape comprises coextrusion of the barrier layer and the outer layer to a forming roll. The method of claim 13, wherein the barrier layer and the outer layers are simultaneously extruded into a molding roll using a multi-slot multi-outlet flat head. The method of claim 12, wherein the outer layer comprises gelatin and a sticky substance. The method of claim 12, wherein the barrier layer comprises paraffin wax, polyethylene homopolymer, polyethylene copolymer, polymer obtained from the polymerization of a monomer selected from the group consisting of acrylamide, acrylic acid, acrylonitrile, caprolactones, ethylene, furan, acrylic anhydride, methacrylate, methacrylate. methacrylate, methylpropylene, styrene, vinyl acetate, vinyl alcohol, vinyl chloride, vinylethyl ether, vinyl propyl ether, vinyl pyrrolidone, salts or mixtures thereof, hydrocarbon, polyethylene wax, microcrystalline waxes, synthetic esters, natural esters, natural long chain alcohols, synthetic alcohols, long chain fatty acids, synthetic long chain fatty acids, ether or mixtures thereof. 17. A soft gelatin capsule produced by a rotary-head process, wherein the capsule comprises: (a) a housing comprising an outer layer and water retaining means; and (b) a pumpable fill material in the housing, wherein the fill material comprises up to about 100% water based on the weight of the fill material, the water retaining means being positioned between the outer layer and the fill material. . The gelatin capsule of claim 17, wherein the water retention means comprises a barrier layer disposed in the outer gelatin layer. 19. Soft gelatinous capsules, made by a rotary head method, wherein the capsule comprises: (a) a housing comprising a means for retaining water; and (b) a packing material encapsulated in the housing, wherein the packing material comprises a solvent system comprising up to about 100% water based on the weight of the solvent system. A method of preventing the migration of materials from a filler material disposed in a gelatin capsule to a gelatin layer of a gelatin capsule, which comprises making a capsule shell comprising a gelatin layer isolated from the filler material by a barrier layer. A composite film comprising a gelatin layer and a barrier layer resistant to permeation of hydrophobic and hydrophilic materials. The composite film of claim 21, wherein the barrier layer is resistant to water permeation. 23. A soft gelatin capsule, made by a rotary head method, wherein the capsule comprises: (a) a multilayer housing having an outer layer and a plurality of inner layers, wherein the at least one inner layer is a barrier layer; the barrier layer is located between the outer layer and the filler material; the outer layer comprises gelatin and the barrier layer is resistant to migration of hydrophilic, amphiphilic or hydrophobic components from the filler material into the outer layer. 24. A soft gelatin capsule made by a rotary head method, wherein the capsule comprises: (a) a bilayer housing having an outer layer and a barrier layer; and (b) a pumpable packing material enclosed within the housing, wherein the packing material comprises a hydrophilic component, an amphiphilic component, a hydrophobic component, or mixtures thereof; the barrier layer is located between the outer layer and the filler material; the outer layer comprises gelatin and the barrier layer is resistant to migration of hydrophilic, amphiphilic and hydrophobic components from the filler material into the outer layer. 25. A soft gelatin capsule made by a rotary head method, wherein the capsule comprises: (a) a three-layer sheath having an outer layer and two inner layers, wherein at least one inner layer is a barrier layer; the outer layer comprises gelatin and the barrier layer is resistant to migration of hydrophilic, amphiphilic and hydrophobic components from the filler material into the outer layer. 26. A soft gelatin capsule made by a rotary head method, wherein the capsule comprises: (a) a housing having at least one outer layer and at least one barrier layer; and (b) a pumpable filling material disposed within the housing, wherein the filling comprises a hydrophilic component, a hydrophobic component, an amphiphilic component, or mixtures thereof; the barrier layer is located between the outer layer and the filler material; the outer layer comprises gelatin and the barrier layer is resistant to migration of the housing components from the outer layer to the filler material. A soft gelatin capsule produced by a rotary head method, wherein the capsule comprises: (a) a housing having at least one outer layer, an inner layer and a barrier layer disposed between the outer and inner layers, wherein the outer and inner layers are gelatinous layers; and (b) a pumpable filling material disposed within the housing, wherein the filling comprises a hydrophilic component, a hydrophobic component, an amphiphilic component, or mixtures thereof; the barrier layer is resistant to migration of hydrophilic, amphiphilic and hydrophobic components from the filler material into the outer layer. A soft gelatin capsule comprising (a) a shell having a sealing and at least one outer layer and at least one barrier layer; and (b) a pumpable filling material disposed within the housing, wherein the filling comprises a hydrophilic component, a hydrophobic component, an amphiphilic component, or mixtures thereof; the barrier layer is located between the outer layer and the filler material; the outer layer comprises gelatin and the barrier layer is resistant to migration of the housing components from the outer layer to the filler material. A soft gelatin capsule made by a rotary head method, wherein the capsule comprises (a) a housing having an outer layer, an inner layer and a barrier layer disposed between the outer and inner layers, wherein the outer and inner layers are gelatinous layers; and (b) a pumpable filling material disposed within the housing, wherein the filling comprises a hydrophilic component, a hydrophobic component, an amphiphilic component, or mixtures thereof; the barrier layer is located between the outer layer and the filler material; the outer layer comprises gelatin and the barrier layer is resistant to migration of hydrophilic, amphiphilic and hydrophobic components from the filler material into the outer layer.