AU2022333645A1

AU2022333645A1 - A softgel capsule composition, and a process for producing a softgel capsule therefrom

Info

Publication number: AU2022333645A1
Application number: AU2022333645A
Authority: AU
Inventors: Jing Lin; Patrick Mcnamara
Original assignee: Blackmores Ltd
Current assignee: Blackmores Ltd
Priority date: 2021-08-24
Filing date: 2022-08-23
Publication date: 2024-03-14
Also published as: WO2023023738A1; AU2021107198A4

Abstract

A softgel capsule composition that is substantially free of materials of animal or fish origin, a process for producing a softgel capsule from said composition, and a softgel capsule, are disclosed. The softgel capsule composition comprises about 20 to about 50 wt% of a hydroxypropylated starch, about 1 to about 6 wt% of a carrageenan, about 10 to about 40 wt% of a plasticizer, about 0.1 to about 1 wt% of a pH adjusting agent, and about 25 to about 60 wt% of purified water.

Description

A SOFTGEL CAPSULE COMPOSITION, AND A PROCESS FOR PRODUCING A SOFTGEL CAPSULE THEREFROM

Field of the Invention

[0001] The present invention relates to a softgel capsule composition, and more particularly to a softgel capsule that is substantially free of materials of animal or fish origin, and to a process for producing a softgel capsule from said composition.

[0002] The invention has been developed primarily for use in the pharmaceutical and healthcare sector, and will be described hereinafter with reference to this application.

Background of the Invention

[0003] Conventionally, softgel capsules have been manufactured using gelatin as a base material to form the outer shell of the capsule. Gelatin is an artificially made protein produced by the partial hydrolysis of collagen derived from the skin or bone tissue from animals and fish. Therefore, gelatin is not suitable for certain persons for example, vegans or those of a particular religion or faith, who elect not to eat products of animal origin.

[0004] A number of softgel capsules have been manufactured from non-animal based materials, such as plant-based material. However, manufacturers have struggled to identify a suitable combination of such materials to match the excellent gel forming property and gel strength of gelatin.

[0005] The present invention thus seeks to provide a softgel capsule composition, and a process for producing a softgel capsule therefrom, which will overcome or substantially ameliorate at least some of the deficiencies of the prior art, or to at least provide an alternative.

[0006] It is to be understood that, if any prior art information is referred to herein, such reference does not constitute an admission that the information forms part of the common general knowledge in the art, in Australia or any other country. Summary of the Invention

[0007] According to a first aspect of the present invention there is provided a softgel capsule composition, comprising:

- about 20 to about 50 wt% of a hydroxypropylated starch;

- about 1 to about 6 wt% of a carrageenan;

- about 10 to about 40 wt% of a plasticizer;

- about 0.1 to about 1 wt% of a pH adjusting agent; and

- about 25 to about 60 wt% of purified water.

[0008] Suitably, the composition is substantially free of materials of animal or fish origin.

[0009] In one embodiment, the hydroxypropylated starch is hydroxypropylated tapioca starch.

[0010] In one embodiment, the carrageenan is iota-carrageenan.

[0011] Preferably, the plasticizer is selected from the group consisting of glycerol and sorbitol.

[0012] In one embodiment, the plasticizer is glycerol.

[0013] In one embodiment, the pH adjusting agent is anhydrous disodium phosphate.

[0014] In one embodiment, the composition further comprises a gelling agent selected from the group consisting of agar, pectin, pullulan and gellan gum.

[0015] In one embodiment, the gelling agent is about 0.5 to about 5 wt% of agar.

[0016] In one embodiment, the gelling agent is about 0.5 to about 5.5 wt% of pectin.

[0017] In one embodiment, the gelling agent is about 0.5 to about 5 wt% of pullulan.

[0018] In one embodiment, the gelling agent is about 0.05 to about 2 wt% of gellan gum.

[0019] Preferably, the composition further comprises one or more additives selected from the group consisting of flavoring agents, flavour enhancers, opacifying agents, preservatives, embrittlement inhibiting agents, colourants and disintegrants. [0020] According to a second aspect of the present invention there is provided a process for producing a softgel capsule, comprising the steps of: a) combining about 20 to about 50 wt% of a hydroxypropylated starch, about 1 to about 6 wt% of a carrageenan, about 10 to about 40 wt% of a plasticizer and about 25 to about 60 wt% of purified water to form a mixture; b) adjusting the pH of the mixture to about pH 7 using about 0.1 to about 1 wt% of a pH adjusting agent; c) stirring the pH adjusted mixture at a temperature of 95 degrees °C to obtain a uniform translucent gel; d) dearating the uniform translucent gel to form a dearated gel; e) extruding the dearated gel through two extrusion dies or spreader boxes to form two continuous gel films / ribbons, f) dispensing a fill material between the two continuous gel films / ribbons; g) heat sealing the two continuous films I ribbons together to encapsulate the fill material therewithin; and h) cutting the heat-sealed gel films I ribbons to form a plurality of softgel capsules comprising the encapsulated fill material.

[0021] In one embodiment, the dearated gel has a viscosity that falls within a range of about 10,000 cP to about 60,000 cP

[0022] In one embodiment, the continuous gel film has a wet gel strength that is not less than about 310 gm.

[0023] In one embodiment, the continuous gel film has an extensibility that is not less than about 8.0 mm.

[0024] In one embodiment, the continuous gel film has a disintegration time that is not more than about 25 minutes.

[0025] In one embodiment, each of the plurality of soft-gel capsules is hermetically sealed. [0026] In one embodiment, the fill material comprises at least one ingredient as an oil or a paste dissolved or suspended in oil, or a powder suspended in a carrier liquid.

[0027] In one embodiment, the at least one ingredient is an active pharmaceutical ingredient (API), a nutraceutical ingredient or a cosmetic ingredient.

[0028] In one embodiment, the nutraceutical ingredient is selected from the group consisting of a vitamin in the form of vitamin A, vitamin B1 , vitamin B2, vitamin C, vitamin D, vitamin E, a mineral in the form of an inorganic salt, an oxide or an amino acid chelate, zinc, iron, magnesium, manganese, calcium, selenium, chromium, a nutritional supplement, a fish oil, algal oil, linseed oil, evening primrose oil, Co-enzyme Q10, a glucosamine salt, a carotenoid, choline, a phospholipid, a herbal extract in a powdered or liquid form, and an essential oil.

[0029] In one embodiment, the carrier liquid is selected from the group consisting of an oil, a surfactant and a pre-concentrate emulsion.

[0030] According to a third aspect of the present invention there is provided a softgel capsule, comprising a composition according to the first aspect, in combination with a fill material, and processed according to the second aspect.

[0031] Other aspects of the invention are also disclosed.

Detailed Description of Specific Embodiments

[0032] For the purpose of making the desired outcomes and advantages of the present disclosure clearer, further detailed description will be made to the present disclosure in conjunction with specific embodiments. It should be understood that these descriptions are exemplary only and are not intended to limit the scope of the present disclosure.

[0033] With this in mind, the present invention is predicated on producing a softgel capsule that is substantially free of materials of animal or fish origin, yet exhibits an excellent gel forming property and gel strength, on a par with the conventionally used animal-based material, gelatin.

[0034] In that regard, the softgel capsule composition desirably shows:

• an instant gel forming property upon casting on manufacturing equipment; • a wet gel strength that is higher than 300 gm;

• a gel viscosity that is appropriate for use on manufacturing equipment; and

• an acceptable thermal stability.

[0035] In addition, the softgel capsule composition desirably forms a gel film having:

• a disintegration test result that is not more than 30 minutes.

Composition

[0036] In a general form, the present invention provides a composition for use in producing a softgel capsule that is substantially free of materials of animal or fish origin.

[0037] As will be described in detail below, the composition of preferred embodiments of the present invention does not contain gelatin but rather, contains in its place, at least two (2) components: 1 ) iota-carrageenan, and 2) a modified starch, that when formulated as a softgel capsule composition in a suitable ratio by weight, produce a dearated gel having a wet gel strength and film forming property that are comparable with those of gelatin.

[0038] To facilitate gel formation, the softgel capsule composition further comprises one or more plasticizers to make the resulting softgel capsule more elastic and pliable and therefore less prone to brittleness and cracking. In this regard, the plasticizer helps to provide improved extensibility and sealability in the composition, allowing for the formation of strong seams between two as-formed continuous gel films formed from the softgel capsule composition during manufacturing to ensure that the encapsulation of a fill material therewithin amounts to a good hermetic seal.

[0039] Iota-carrageenan is a water soluble gum comprised of a linear polysaccharide with a sugar backbone of alternating units consisting of galactose units linked by 1 ,3- [3-D-linkages, as well as 1 ,4-a-D-linkages.

[0040] The inventors have identified that iota-carrageenan has good gel forming properties, but poor film forming properties.

[0041] To address this issue, the inventors have formulated and tested the following compositions comprising various components in combination with iota-carrageenan in order to produce a gel, whereby the poor film forming properties of iota-carrageenan are improved.

[0042] The results are illustrated in Table 1.

Table 1

[0043] As reflected in Table 1 , the formulations (samples 2 and 3) containing hydroxypropylated tapioca starch and carrageenan with gellan gum or pectin produce a gel film that displayed a medium wet gel strength. However, the formulation (sample 1 ) comprising hydroxypropylated pea starch was found to be too weak to form a gel film.

[0044] Based on the results above, the inventors have found that the combination of hydroxypropylated tapioca starch and iota-carrageenan results in a gel film having the best gel properties.

[0045] The inventors conducted further development work in order to optimise the formulation by varying the input ratio of the hydroxypropylated tapioca starch and iota- carrageenan, as described below.

Gel Preparation

[0046] A general process for preparing a gel film for use in producing a softgel capsule will now be described.

[0047] According to a first step, about 20 to about 50 wt% of a hydroxypropylated starch, about 1 to about 6 wt% of a carrageenan, about 10 to about 40 wt% of a plasticizer and about 25 to about 60 wt% of purified water are combined in a vessel to form a mixture.

[0048] According to a second step, the pH of the mixture is adjusted to about pH 7 by introducing about 0.1 to about 1 wt% of a pH adjusting agent into the vessel. The pH adjusted mixture is then stirred in the vessel at a temperature of 95 °C according to a third step to obtain a uniform translucent gel.

[0049] The uniform translucent gel is then dearated in a gel melter according to a fourth step, and then discharged into holding vessels until required to be used in the subsequent encapsulation process, which will be described in more detail below.

[0050] The results of the investigation to optimise the formulation are summarised in Table 2 below.

Table 2

[0051] Based on the results in Table 2, the inventors have identified that an ideal amount of iota-carrageenan used in the softgel capsule composition is from about 1% to about 6% by weight of the total composition, and desirably from about 2% to about 5% by weight of the total composition.

[0052] The inventors have also identified that a suitable modified starch for use in producing a softgel capsule, in combination with iota-carrageenan, is hydroxypropylated tapioca starch, and that an ideal amount of hydroxypropylated tapioca starch used in the softgel capsule composition is from about 20% to about 50% by weight of the total composition, and desirably from about 20% to about 39% by weight of the total composition.

[0053] The inventors have also identified that an ideal amount of glycerol (sold commercially under the name glycerin (B.P.)) used in the softgel capsule composition as a plasticizer is from about 10% to about 40% by weight of the total film-forming composition, and desirably from about 10% to about 19% by weight of the total filmforming composition. [0054]The balance is made up by purified water (B.P./E.P.) in an amount from about 25% to about 60% by weight of the total composition, and desirably from about 38% to about 55% by weight of the total composition, adjusted to a pH of 7.0 using anhydrous disodium phosphate, added to the composition in a range of from about 0.1 % to about 1 wt% by weight of the total composition.

[0055] To assess the film forming properties of the as-formed dearated gel samples in Table 2, each dearated gel sample was heated to a flowable state, and then cast onto cooling drums by extrusion dies to form a continuous gel film or ribbon.

Wet Gel Strength

[0056] A wet gel strength test was carried out on the gel films (of 40 Thou thickness (1 thou = 0.025400 mm) shown in Table 2 using a TA.XTp/us Texture Analyser (Stable Micro Systems Ltd) according to a standard wet gel strength test protocol.

[0057] The wet gel strength of the gel films is desirably in the range of from about 275 to about 480 gm, and more desirably is not less than 310 gm.

[0058] The highest wet gel strength was obtained for sample 9, which is a suitable value for processing on a rotary die encapsulation apparatus. However, the viscosity of sample 9 is too high for this sample to be used on the apparatus.

Extensibility Test

[0059] An extensibility test was carried out on the gel films shown in Table 2 according to a standard extensibility test protocol.

[0060] The extensibility of the gel films is desirably in the range of from about 5 to about 15 mm. and more desirably in the range of from about 8 to about 15 mm.

Viscosity

[0061] The viscosity of the gel films is desirably in the range of from about 10,000 cP to about 60,000 cP, and more desirably in the range of from about 20,000 cP to about 55,000 cP, as measured at 90°C using a mechanical rheometer (Thermo Scientific HAAKE RheoStress 6000) at a shear rate of 0 to 100 per second in two (2) minutes. - I Q -

10062] The viscosity of sample 8 at 90°C, on the other hand, is considered to be appropriate for processing on the rotary die encapsulation apparatus, while the wet gel strength is acceptable.

Disintegration Test

[0063] A disintegration test was carried out on the gel films in Table 2 according to the disintegration test protocol prescribed in the British Pharmacopoeia.

[0064] The disintegration time of the gel films is desirably in the range of from about 2 minutes to about 30 minutes, and more desirably in a time that is not more than 30 minutes.

[0065] Given the results highlighted in Table 2, the formulation of sample 8 was subsequently chosen for the purposes of a test study for encapsulation purposes on a customised gel melter and rotary die encapsulation apparatus (RP Scherer Corp.).

Encapsulation and Drying

[0066]Softgel capsules may be manufactured in accordance with conventional techniques.

[0067] Basically, the manufacture of uniform softgel capsules requires a film-forming composition that has good "machineability" i.e., it is important that the film-forming composition be able to be brought into contact with rollers or other machine parts during processing without sticking onto these machine parts.

[0068] As described herein, softgel capsules according to embodiments of the present invention are produced using a rotary die encapsulation apparatus. Softgel capsules made using a rotary die encapsulation apparatus will typically have wet shell thicknesses that vary from about 0.68 to 1.0 mm, preferably from about 0.71 to 0.93 mm, and more preferably from about 0.74 to 0.86 mm in thickness. The softgel capsules may be manufactured in any desired shape using the abovementioned rotary die encapsulation apparatus.

[0069] As those skilled in the art of softgel capsule manufacture will appreciate, the film formed on the drum of the rotary die encapsulation apparatus is called a “wet film'. This film is used in the rotary die encapsulation apparatus to form the filled softgel capsules.

[0070] The softgel capsules are dried by passing them through tumble driers, and further by subsequently spreading them out onto shallow trays for final drying in a humidity and temperature-controlled room. During the drying process, water is removed from the fill material (when the fill material is hydrophilic) and the outer softgel capsule shell itself. The result is a softgel capsule with a “dry film”.

RESULTS

[0071] The softgel capsule composition of the preferred embodiment of the present invention forms a gel film that is mechanically strong and exhibits elasticity sufficient to allow the film to stretch during filling (blow moulding) with a fill material.

[0072] Thus, the obtained gel film has dimensional stability, elasticity and a wet gel strength that renders it adequate for use in a continuous process which requires their removal from a casting drum and subsequent transport to rotary dies. The gel film formed from the composition simultaneously fuses together during the filling and cutting portion of the rotary die process when subjected to sufficient pressure (approx.1600 kPa) and elevated temperature (approx. 41 °C) to form a hermetic seal.

[0073] A process for producing a softgel capsule using the composition of sample 8 will now be described.

Encapsulation Process

[0074] The dearated gel is taken from the holding vessel and extruded using a rotary die encapsulation apparatus, according to a first step of the process to form a continuous gel film or ribbon.

[0075] Specifically, the dearated gel is softened at approx. 97 °C to form a gel fluid, which is then pumped through two extrusion dies to simultaneously form two continuous gel films or ribbons.

[0076] The gel films are then extruded directly to two cooling drums for transportation to two rotary dies. [0077] According to a second step, a fill material is dispensed from a filling station and injected through a wedge in between the two gel films travelling through two counterrotating dies, thereby encapsulating the fill material between the gel films. The two gel films are then heat-sealed together and cut by virtue of the temperature (approx. 41 °C) and die pressure (approx. 1600 kPa) generated by the wedge and the counterrotating dies to form individual softgel capsules comprising the encapsulated fill material therewithin.

[0078] The fill material may be any of a wide variety of materials suitable for encapsulation using the rotary die encapsulation apparatus. Among the types of materials that are suitable for encapsulation include active and/or non-active ingredients dissolved or suspended in a carrier liquid, which may be an oil, a surfactant or a pre-emulsion concentrate.

[0079] The active ingredients that may be contained within the oils and emulsions include hydrophobic and hydrophilic active ingredients. It will be appreciated that those persons skilled in the relevant art will be familiar with and will recognize suitable fill materials.

[0080] These fill materials may contain nutraceutical ingredients in the form of liquids, semi-solids, suspensions, cosmetic ingredients and pharmaceuticals (i.e. an active pharmaceutical ingredient (API)).

[0081] In one embodiment, the nutraceutical ingredient is selected from the group consisting of a vitamin in the form of vitamin A, vitamin B1 , vitamin B2, vitamin C, vitamin D, vitamin E, a mineral in the form of an inorganic salt, an oxide or an amino acid chelate, zinc, iron, magnesium, manganese, calcium, selenium, chromium, a nutritional supplement, a fish oil, algal oil, linseed oil, evening primrose oil, Co-enzyme Q10, a glucosamine salt, a carotenoid, choline, a phospholipid, a herbal extract in a powdered or liquid form; and an essential oil.

[0082] After filling, the softgel capsules are typically dried according to conventional techniques, e.g., using a drum dryer then tray drying, or other suitable drying method. Definitions

[0083] As used herein, the term “substantially free” when used in reference to a softgel capsule composition, generally means that the composition constitutes less than about 1 %, less than about 0.5%, less than about 0.1 %, less than about 0.05%, less than about 0.01 %, less than about 0.001 %, less than about 0.0001 %, less than about 0.00001 %, less than about 0.000001 % or less than about 0.0000001 % of materials of animal or fish origin.

[0083a] As used herein, the term "softgel" means a softgel capsule, in agreement with the accepted nomenclature. Generally, a softgel capsule is a one-piece, sealed, softgel (or other film-forming material) that contains a solution, a suspension, or a semi-solid paste.

[0084] As used herein, the term "capsule" refers to a softgel, or any other encapsulated dosage form known to persons skilled in the relevant art, or a portion thereof.

[0085] The phrase "fill material" as used herein encompasses any fill material or composition thereof in a form suitable for encapsulation by the softgel capsule described herein. Thus, a fill material can be a pharmaceutical or nutritional composition, or a cosmetic, paint, soap, bath oil or other desirably encapsulated product. The fill material can be a solid (low melting point), liquid, gel, suspension or any other form suitable for encapsulation.

[0086] As used herein, the term "encapsulated" and other forms of the word "encapsulate" mean placing a fill material inside of a softgel capsule, such that the fill material is completely surrounded by the softgel capsule.

[0087] As used herein, the term "capsule shell" refers to the outer shell of a softgel capsule produced by a rotary die encapsulation apparatus using the softgel capsule composition described herein, for further use in encapsulating a fill material.

[0088] As used herein, the term "sealability" refers to the ability of two continuous gel films produced using the softgel capsule composition set forth herein to fuse together using methods known to persons skilled in the relevant art, such as but not limited to the application of heat and/or pressure. The seam that is created upon fusing should be continuous and strong to provide a hermetic seal to prevent leakage of encapsulated fill material therefrom.

[0089] As used herein, the term "about' as used herein when referring to a measurable value such as a parameter, an amount, a temporal duration, and the like, is meant to encompass variations of ±10% or less, preferably ±-5% or less, more preferably ±1 % or less, and still more preferably ±0.1 % or less of and from the specified value, insofar such variations are appropriate to perform in the disclosed invention. It is to be understood that the value to which the modifier "about" refers is itself also specifically, and preferably, disclosed.

[0090] As used herein, the singular forms "a", "an", and "the" include both singular and plural referents unless the context clearly dictates otherwise.

CONCLUSION

[0091] The results obtained for the softgel capsule composition of sample 8 supports the conclusion that this modified starch/carrageenan composition possesses a gel strength and film forming property that is comparable to gelatin, and therefore allows for its satisfactory use in a rotary die encapsulation apparatus to form a filled softgel capsule.

ADVANTAGES

[0092] The softgel capsule composition, as described in embodiments of the present invention herein, provides a number of advantages, including, but not limited to:

• an instant gel forming property upon casting on manufacturing equipment;

• a wet gel strength that is higher than 300 gm;

• a gel viscosity that is appropriate for use on manufacturing equipment; and

• an acceptable thermal stability.

[0093] The softgel capsule composition desirably forms a gel film having:

• a disintegration test result that is not more than 30 minutes. Embodiments:

[0094] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments.

[0095] Similarly, it should be appreciated that in the above description of example embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the Detailed Description of Specific Embodiments are hereby expressly incorporated into this Detailed Description of Specific Embodiments, with each claim standing on its own as a separate embodiment of this invention.

[0096] Furthermore, while some embodiments described herein include some, but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.

Other Embodiments

[0097] It will be understood by persons of skill in the relevant art that the composition for producing the softgel capsule as described in embodiments of the present invention above, is not simply limited to the components described above. [0098] For instance, in other embodiments, the composition may further comprise a gelling agent in combination with the other components, wherein the gelling agent is selected from the group consisting of agar, pullulan and gellan gum. For example, the gelling agent may be agar provided in the range of about 0.5 to about 5 wt% of the composition. Alternatively, the gelling agent may be pectin provided in the range of from about 0.1 to about 5.5 wt% of the composition. In another embodiment, the gelling agent may be pullulan provided in the range of about 0.5 to about 5 wt% of the composition. Alternatively, in another embodiment, the gelling agent may even be gellan gum provided in the range of about 0.05 to about 2 wt% of the composition.

[0099] In other embodiments, the composition may additionally comprise one or more additives selected from the group consisting of a colorant(s) and a flavour enhancer(s).

[00100] Other additives may also be incorporated into the softgel capsule composition provided they do not alter the characteristics of the resulting gel film. Representative of these additives include flavoring agents, flavour enhancers, opacifying agents, preservatives, embrittlement inhibiting agents, colourants and disintegrants.

[00101] The softgel capsule compositions are typically in the molten state when these additional components are added. Use of conventional pharmaceutical or food grade ingredients is acceptable.

[00102] These additives may be added in any amount known to persons skilled in the relevant art to achieve the desired effect without altering the gel strength or filmforming properties of the softgel capsule composition. Desirably, the total amount of all additives does not exceed about 5% by weight of the composition, more desirably, it does not exceed about 1 % by weight of the composition.

Comprising and Including

[00103] In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word "comprise" or variations such as "comprises" or "comprising" are used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

[00104] Any one of the terms: including or which includes or that includes as used herein is also an open term that also means including at least the elements/features that follow the term, but not excluding others. Thus, including is synonymous with and means comprising.

Scope of Invention

[00105] Thus, while there has been described what are believed to be the preferred embodiments of the invention, those skilled in the art will recognize that other and further modifications may be made thereto without departing from the spirit of the invention, and it is intended to claim all such changes and modifications as fall within the scope of the invention. For example, any formulas given above are merely representative of procedures that may be used.

[00106] Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms.

Industrial Applicability

[00107] It is apparent from the above, that the arrangements described are applicable to the pharmaceutical and healthcare sector.

Claims

1 . A softgel capsule composition, comprising: a) about 20 to about 50 wt% of a hydroxypropylated starch; b) about 1 to about 6 wt% of a carrageenan; c) about 10 to about 40 wt% of a plasticizer; d) about 0.1 to about 1 wt% of a pH adjusting agent; and e) about 25 to about 60 wt% of purified water.

2. The composition according to claim 1 , substantially free of materials of animal or fish origin.

3. The composition according to claim 1 , wherein the hydroxypropylated starch is hydroxypropylated tapioca starch.

4. The composition according to claim 1 , wherein the carrageenan is iota carrageenan.

5. The composition according to claim 1 , wherein the plasticizer is selected from the group consisting of glycerol and sorbitol.

6. The composition according to claim 1 , wherein the plasticizer is glycerol.

7. The composition according to claim 1 , wherein the pH adjusting agent is anhydrous disodium phosphate.

8. The composition according to claim 1 , further comprising a gelling agent selected from the group consisting of agar, pectin, pullulan and gellan gum.

9. The composition according to claim 8, wherein the gelling agent is about 0.5 to about 5 wt% of agar.

10. The composition according to claim 8, wherein the gelling agent is about 0.5 to about 5.5 wt% of pectin.

1 1 .The composition according to claim 8, wherein the gelling agent is about 0.5 to about 5 wt% of pullulan.

12. The composition according to claim 8, wherein the gelling agent is about 0.05 to about 2 wt% of gellan gum. The composition according to claim 1 , further comprising one or more additives selected from the group consisting of flavoring agents, flavour enhancers, opacifying agents, preservatives, embrittlement inhibiting agents, colourants and disintegrants. A process for producing a softgel capsule, comprising the steps of: a) combining about 20 to about 50 wt% of a hydroxypropylated starch, about 1 to about 6 wt% of a carrageenan, about 10 to about 40 wt% of a plasticizer and about 25 to about 60 wt% of purified water to form a mixture; b) adjusting the pH of the mixture to about pH 7 using about 0.1 to about 1 wt% of a pH adjusting agent; c) stirring the pH adjusted mixture at a temperature of 95°C to obtain a uniform translucent gel; d) dearating the uniform translucent gel to form a dearated gel; e) extruding the dearated gel through two extrusion dies or spreader boxes to form two continuous gel films / ribbons, f) dispensing a fill material between the two continuous gel films / ribbons; g) heat sealing the two continuous films I ribbons together to encapsulate the fill material therewithin; and h) cutting the heat-sealed gel films I ribbons to form a plurality of softgel capsules comprising the encapsulated fill material. The process according to claim 14, wherein the dearated gel has a viscosity that falls within a range of about 10,000 cP to about 60,000 cP The process according to claim 14, wherein the continuous gel film has a wet gel strength that is not less than about 310 gm. The process according to claim 14, wherein the continuous gel film has an extensibility that is not less than about 8.0 mm. The process according to claim 14, wherein the continuous gel film has a disintegration time that is not more than about 25 minutes. The process according to claim 14, wherein each of the plurality of soft-gel capsules is hermetically sealed. The process according to claim 14, wherein the fill material comprises at least one ingredient as an oil or a paste dissolved or suspended in oil, or a powder suspended in a carrier liquid. The process according to claim 20, wherein the at least one ingredient is an active pharmaceutical ingredient (API), a nutraceutical ingredient or a cosmetic ingredient. The process according to claim 21 , wherein the nutraceutical ingredient is selected from the group consisting of a vitamin in the form of vitamin A, vitamin B1 , vitamin B2, vitamin C, vitamin D, vitamin E, a mineral in the form of an inorganic salt, an oxide or an amino acid chelate, zinc, iron, magnesium, manganese, calcium, selenium, chromium, a nutritional supplement, a fish oil, algal oil, linseed oil, evening primrose oil, Co-enzyme Q10, a glucosamine salt, a carotenoid, choline, a phospholipid, a herbal extract in a powdered or liquid form; and an essential oil. The process according to claim 20, wherein the carrier liquid is selected from the group consisting of an oil, a surfactant and a pre-emulsion concentrate. A softgel capsule, comprising a composition according to any one of claims 1 to 12, in combination with a fill material, and processed according to any one of claims 14 to 23.