FORM 2
THE PATENT ACT 1970
(39 of l970)
&
The Patents Rules, 2003
PROVISIONAL SPECIFICATION
(See section 10 and rule l3)
1. TITLE OF THE INVENTION:
"GELATIN FREE SOFT CAPSULE SHELL COMPOSITION AND METHOD FOR MANUFACTURING THE SAME."
2. APPLICANT
(a) NAME: STRIDES ACROLAB LIMITED
(b) NATIONALITY: Indian Company incorporated under the Indian
Companies ACT, 1956
(c) ADDRESS: No. 201, 'Devavrata', Sector 17, Vashi, Navi Mumbai - 400703,
Maharashtra, India.
3. PREAMBLE TO THE DESCRIPTION
The following specification describes the invention:

Technical field of the invention:
The present invention relates to a novel composition suitable for forming films for soft capsules, comprising a mixture of polysaccharides. This composition may further comprise optional ingredients such as buffers, plasticisers, opacifiers, coloring agents, preservatives, gums and etc to improve film forming properties of the soft capsules such as elasticity, strength and sealing.
Background and prior art:
Formulation of soft capsule which typically comprise a solution or dispersion of a nutritional or pharmaceutical agent in liquid carrier(s) offers many advantages over other dosage forms such as tablets, capsules or bulk liquid preparations. Encapsulation of a solution or dispersion permits accurate delivery of a unit dose, an advantage which becomes especially important when relatively small amounts of the active ingredient must be delivered, as in the case of certain hormones. Such uniformity is more difficult to achieve via a tableting process wherein solids must be uniformly mixed and compressed, or via incorporation of the total dose of active ingredient into a bulk liquid carrier which must be measured out prior to each oral administration.
Soft capsules, most commonly soft gelatin capsules, provide a dosage form which is more readily accepted by patients, since the capsules are easy to swallow and need not be flavored in order to mask the unpleasant taste of the active agent. Liquid filled soft capsules are also more easily transported by patients as compared to oral suspensions or oral solutions.
Presence of active ingredients as solution or suspension in soft capsules provides the potential to improve the bioavailability of pharmaceutical agents. Active ingredients are rapidly released in liquid form as soon as the shell ruptures. Complete disintegration of the capsule is not necessary for the active ingredients to become available for absorption, unlike the case of tableted compositions. Also, relatively insoluble active ingredients can be dispersed in a liquid carrier to provide faster absorption.


Gelatin has been widely used as a main ingredient for formation of both hard and soft capsules. Gelatin is manufactured by the hydrolysis of the animal by-products that contain collagen. This is usually found in animal bones, skins and connective tissues. The primary sources of gelatin are from bovine and swine animals. Additionally, fish and poultry are alternative small volume sources of gelatin.
A major disadvantage and limiting factor of the use of gelatin is the possibility of cross-contamination of diseases among species carried forward via gelatin. For example-bovine spongiform encephalopathy (BSE) or Mad Cow Disease have been reported as a contamination due to consumption of gelatin containing dose forms (HGC/SGC).
Use of gelatin as the key ingredient of soft capsule shell limits the acceptance of this dosage form among large patient population of certain religious beliefs. Also the source of gelatin could be potential problem to the set of people who does not consume products of pigs (e.g., Muslims). As medication and/or diet supplements are provided in gelatin capsules without any indication of the source of the gelatin, the use of capsules is restricted in the areas where religious beliefs question the source of the gelatin.
Hence, there is a need for replacement of gelatin, to prepare soft capsules to address concerns of vegetarians, and certain religious groups to ensure a total patient compliance and any possible contamination.
U.S. Patent No. 6582727 granted to R P Scherer discloses the composition comprising modified starch and a carrrageenan, especially iota-carrrageenan, where the composition are suitable for use in manufacturing of soft capsules.
U.S. Patent No. 6949256B2 discloses a film-forming hydrocolloid composition comprising kappa carrageenan, iota carrageenan, a bulking agent, plasticizer and water is described. The ratio of bulking agent to total carrageenan is from about 1:1 to 20:1. Kappa carrageenan is present in an amount of less than or equal to 50% by weight of total carrageenan present. To form the composition, all dry materials are mixed and added to a heated mixture of all liquid materials. The final mixture is heated until a composition free of particulate materials is formed. The formed composition can be cast or extruded into


ribbons, films, sheets, tubes or the like, for encapsulating wet or dry materials including medicinal dosage forms, nutritional supplements, cosmetics, bath oils and gels, and paint balls.
Japanese Patent Application Kokai Publication No. 63-164858 discloses a composition for the outer skin of soft capsules that allows the filling of hydrophilic materials into the capsule. The composition is a mixture of at least one natural polysaccharide selected from alginic acid, alginic acid derivatives, agar, locust bean gum, carrageenan, guaic gum, tamarind seed polysaccharide, pectin, xanthan gum, glucomannan, chitin, pluran, and cyclodextrin; and at least one substance selected from polyvalent alcohols, sugar alcohols, monosaccharides, disaccharides, and oligosaccharides.
International Patent Application No. PCT/FR98/01744 (WO 97/07347) discloses a composition for the manufacture of soft and hard capsules that uses iota-carrageenan as the only gelling agent at concentrations of greater than 5% by weight. This reference does disclose the use of starches and surfactants in the composition at levels of up to 20% by weight for the purpose of accelerating the disintegration of the capsule after contacting gastric juices.
U.S. Patent No. 5,342,626 granted to Winston et al. discloses a composition comprising gellan, carrageenan and mannan gums for producing soft capsules. This patent further discloses that the tri blend of gums can be combined with additional ingredients to form a film-forming polymer composition.
Japanese Patent Application No. HEI9-25228 discloses a soft capsule film having as essential components agar and water-soluble high polymers, such as the carrageenans.
In a similar fashion, Japanese Patent Application Disclosure No. HE15-3I0529 discloses a capsule forming film comprising agar and carrageenan. The reference points out that kappa carrageenan were found to be preferable.
Japanese Public Patent Disclosure Bulletin No. 61-10508 discloses capsules made from polysaccharides which contain carrageenan and a base which contains multivalent


alcohols. The multivalent alcohols include sorbitol, ethylene glycol, glycol, glycerin and
the like.
Another reference suggesting the use of kappa-carrageenan to form capsules is seen in
Japanese Patent Application Disclosure No. SHO60-12943. This reference teaches the
exclusive use of kappa carrageenan in concentrations of about 1 to about 12% by weight.
This reference also suggests that suitable plasticizers or gelatins can be included for
increasing film strength.
U.S. Patent No. 5,089,307 granted to Ninomiya et al. discloses a heat sealable, edible film comprising a film layer consisting essentially of: 1) a water soluble polysaccharide composed chiefly of carrageenan; 2) a polyhydric alcohol; and 3) water. The film of this patent has a water content of not greater than 25% by weight and a weight ratio of the polyhydric alcohol to the water soluble polysaccharide being in the range from 1:5 to 1:1. This reference does mention all three (3) forms of carrageenan, kappa, iota and lambda.
As evident, the above cited prior arts suggest the use of carrageenan as an appropriate alternative to gelatin. The present invention employs the combination of natural occuring polysaccharides selected from the group comprising of Pullalan, as a key ingredient. Use of Carrageenan(s) and/or tamarind seed polysaccharides for the manufacturing of gelatin free soft capsules.
Object of the invention:
The main object of the invention relates to shell composition for manufacturing of gelatin free soft capsule comprising natural polysaccharide such as pullulan as the key ingredient.
Another objective of the present invention is to use other natural polysachharides like-carrageenan and tamarind seed polysachharide, for the shell composition.


Summary of the invention:
The present invention provides compositions for manufacturing soft capsules. The invention provides compositions that do not employ mammalian gelatin and, therefore, overcome the disadvantages associated with collagen-derived material. The present invention relates to the shell composition of a soft capsule comprising natural polysaccharide such as pullulan as the key ingredient. The shell composition also employs other natural polysachharides like- carrageenan and tamarind seed polysachharide, for the shell composition.
As those skilled in the art of soft capsule manufacturing will appreciate, that above said composition may further contain additional ingredients such as buffering agents, gums & etc to improve soft shell properties such as elasticity, strength and sealing.
The composition optionally can include one or more additives as known to practitioners in the art such as an opacifier, preservative, flavorant, colorant and the like.
Though, the use of various types of Carrageenans and modified starches were cited by numerous patent applications/grants, but they fail to identify the novel composition as per our invention. The inventive step as per present invention includes identification of suitable composition comprising mixture of Polysaccharides, especially a combination of Pullalan, Carrageenans and Tamarind seed polysaccharides and process for manufacturing soft capsules using this composition.
However, use Pullalan for manufacturing of soft capsules was not cited as yet in any of the existing prior arts. Similarly, this invention also makes use of tamarind seed polysaccharides, which is obtained from tamarind seeds which were thrown out as waste after taking out pulp for household preparations.
Detailed description of the invention:
Pullalan is a natural, water soluble polysaccharide produced from corn syrup by fermentation and is available as a white, odourless, flavourless and highly stable powder.


Pullalan consists of Glucose units linked through a-1, 4 and a-1,6 glucosidic linkage, having molecular formula (Cf,Hio05)n with average molecular weight of 200kD. It is an excellent film former, producing a film which is edible, heat sealable, printable and has extremely low oxygen permeability. Besides its film forming property, Pullalan has an excellent adhesiveness and is heat, salt, acid, alkali resistant. Pullalan also dissolves readily in cold and hot water. Due to its excellent oxygen barrier properties and high water solubility, Pullalan has a broad range of application in drug delivery system, especially Pullalan can easily replace gelatin in both hard and soft capsules.
Carrageenan is a natural hydrocolloid, more particularly a polysaccharide hydrocolloid, which is derived from red seaweed, particularly of the species Rhodophycea. Carrageenan is a carbohydrate polymer of repeating galactose and 3,6-anhydrogalactose (sugar) units that is linear and without significant numbers of branches or substitutions. Most, if not all, of the galactose units on a carrageenan molecule possess a sulfated ester group. The exact position of the sulfate groups, the cations on the sulfate groups, and the possible presence of an anhydrous bridge on the molecule differentiate the various types of carrageenan.
Tamarind seed polyose is a polysaccharide gum having innumerable qualities, hence is unique with other natural and synthetic gums or products of its kind. It is extracted from the seeds of Tamarindus indica (Imli), which is an agriculture waste. The pulp of the fruit is used in various edible household preparations and the seeds are thrown away as waste. This waste is being utilized for the extraction of the polyose of pharmaceutical grade. The purified polyose should be free from fatty, mineral and nitrogenous impurities, reducing sugars, tannins ad starch. It is dispersible in hot water to form highly viscous jelly like mucilaginous solution, which can be spread on fiat surface, unusual with other natural gums or polysacchriades. It forms a thin film of high tensile strength and flexibility, with stable, non-sticky, non-hygroscopic transparent appearance. It is non-toxic, non-irritant and bioabsorbable by animal tissues. It is this property can lead to formation of capsules.
Invention is further illustrated with the following non limiting examples;


Ingredients Wet Film % by weight
Example No 1 2 3 4 5 6 7 8 9 10 // 12 13 14
Pullalan 16 16 16 16 16 20 20 20 20 20 16 16 16 16
lota-Carrageenan 1.5 0 0 0 0 1.5 0 0 0 0 1.0 0 0 0
Kappa -Carrageenan 0 1.5 0 0 0 0 1.5 0 0 0 0 1.0 0 0
Mu-Carrageenan 0 0 1.5 0 0 0 0 1.5 0 0 0 0 1.0 0
Nu-Carrageenan 0 0 0 1.5 0 0 0 0 1.5 0 0 0 0 1.0
Tamarind seed Polysaccharide 0 0 0 0 2.0 0 0 0 0 2.0 2.0 2.0 2.0 2.0
Glycerin 25 25 25 25 25 25 25 25 25 25 25 25 25 25
Locustbean/gellangum 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0
Sodium Phosphate dibasic (buffer) 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5
Water Quantity sufficient to 100%