Fish gelatinous composition for use as an ingredient in tablets

Details Fish gelatinous composition for use as an ingredient in tablets Fish gelatinous composition for use as an ingredient in tablets

1999-08-24

2002-07-23

Tate, Christopher R. (Department: 1651)

Drug, bio-affecting and body treating compositions

Extract, body fluid, or cellular material of undetermined...

C424S456000, C424S460000, C424S464000, C424S489000, C424S492000, C512S014000

Reexamination Certificate

active

06423346

ABSTRACT:

The present invention relates to a particulate composition comprising one or more physiologically active substances and a gelatinous protective colloid.
Physiologically active substances are enclosed in protective colloids, such as gelatines, i.a. to protect them from influences inflicted during storage, transport, handling and use, e.g. influences from oxygen, moisture and light radiation and physical influences, in order to avoid physical and chemical decomposition of the substance. Furthermore, a protective colloid may be used to prevent the active substance from reacting with other substances present in the composition or with substances with which it may come into contact during use. Also, a protective colloid is used to transform liquids and other substances, which are difficult to handle and process, e.g. due to stickiness, into a solid form suitable for handling and processing during use, such as a powder of microcapsules.
Fish gelatine (also known as fish gelatin) is used for dietary applications, where mammalian gelatines are unacceptable on religious grounds. Fish gelatine is available as Kosher grade.
EP-A1-0 346 879 discloses a composition comprising a solid particulate water insoluble drug coated with a solid fish gelatine coating, wherein the composition is produced by simple coacervation of the fish gelatine. The fish gelatine is soluble at 5-10° C.
WO 96/20612 discloses a method of forming microencapsulated food or flavor capsules as well as capsules produced by the method. The method includes forming a mixture of a warm water fish gelatine and the food or flavor particles in aqueous media, and microencapsulating the particles with the gelatine at a temperature above 16-27° C. by complex coacervation to form microencapsulated capsules, and optionally separating the capsules. Preferably, the warm water fish gelatine used has a bloom of from about 150 to about 300.
Simple and complex coacervation techniques require the use of relatively low concentration solutions of gelatine, and hence the particles formed from the solutions have a relatively high content of water, which is difficult and expensive to remove. Both dried and non-dried particles produced by coacervation have a low ability to resist mechanical influences.
GB-1 200 906 discloses a process for preparing a composition in dry, particulate, free-flowing form and comprising cold water soluble or dispersable gelatine and fat-soluble vitamins, the process comprising partially hydrolysing a gelatine solution by treatment with base or acid at a temperature of 40 to 95° C., neutralising the gelatine solution and finely dispersing therein the fat-soluble vitamin or vitamins, comminuting the emulsion to particles and solidifying the particles. The starting gelatine may be low or high bloom gelatin.
U.S. Pat. No. 4,670,247 discloses a process for preparing fat-soluble vitamin beadlets including forming an aqueous emulsion of a fat-soluble vitamin-active material and a protective colloid comprising gelatine and a reducing sugar, and converting said emulsion to a dry particulate form, wherein the dry particulate form is subjected to heat treatment in order to obtain a cross-linking between the sugar and the gelatine molecules. The gelatine may be any gelatine having bloom of between about 0 and 300.
EP-B1-0 347 751 discloses a stable, cold water-dispersable powder preparation of fat-soluble substances, which are enveloped in a protective colloid in the form of fish gelatine. The fish gelatine used is “Norland HiPure Liquid Gelatin”, which is a zero bloom gelatine.
The prior art fish gelatinous compositions may be used as additives for a wide range of foods. However, the prior art compositions suffer from the drawback that they are not suitable for use as an ingredient in tablets, since particles formed have insufficient strength to resist the mechanical influence to which it is subjected during tabletting.
U.S. Pat. No. 4,892,889 discloses a process for making a directly-compressible vitamin powder utilising a conventional spray-drying method. The process comprises the steps of (A) combining a fat-soluble vitamin, a gelatin having a bloom number between 30 and 300, a water-soluble carbohydrate, and water to form a mixture, and (B) spray-drying the mixture in a conventional spray-drier to form a powder, wherein the content of carbohydrate is sufficient to prevent extrusion of the vitamin.
U.S. Pat. No. 2,824,807 discloses a method of spray drying solutions of gelatine containing e.g. vitamins comprising the steps of atomising the solution in a cool air zone at a temperature of 0-200° F. to form droplets and drying of the droplets in a drying zone at a temperature of 250-1000° F. to effect solidifying of the droplets.
U.S. Pat. No. 4,519,961 discloses a process for pulverising substances, which are sensitive to oxidation, e.g. vitamins, comprising the steps of providing a dispersion of the oxidation-sensitive substance in an aqueous solution containing a film-forming colloid and a saccharides atomising said dispersion within the spraying zone of a spraying tower to form discrete particles while contacting the particles with a hydrophobic spraying assistant at a temperature, at which the colloid does no solidify/gelatinise, and drying the particles laden with the spraying assistant in a fluid bed to solidify them.
Thus, the technical problem addressed by the present invention is to provide a gelatinous composition, which is Kosher acceptable, and which is suitable for use as an ingredient in tablets.
The said technical problem is solved by the particulate composition of the invention comprising one or more physiologically active substances and a fish gelatinous protective colloid containing at least 50% by weight of fish gelatine, wherein the fish gelatine is at least partly composed of fish gelatine having a bloom strength of above 100, and wherein the composition is obtainable by a particle forming spray congelation method or a double emulsifying method.
It has surprisingly been found that particles, which are prepared using fish gelatine having a bloom strength of above 100 and using as a particle forming method either a spray congelation method or a double emulsifying method, have physical properties with respect to resistance to mechanical influences, such as pressure, shear force and impact, which are far superior to those of the prior art particles.
Thus, the present invention is based on the recognition that it is possible to produce a fish gelatinous composition with high mechanical strength, and that such a high strength composition may be used as an ingredient in tablets, such as nutritional supplement tablets. Therefore, the present invention has provided a possibility or producing tablets containing physiologically active substances protected by fish gelatine.
Furthermore, the present invention has provided a possibility of producing a Kosher and Halal acceptable composition for use as an ingredient in tablets.
When the mechanical strength of gelatinous particles is insufficient to resist the mechanical influences inflicted during tabletting, the particles will decompose leading to extrusion of the active substance. Such extrusion results in discolouring of the tablets, which is not acceptable. Also, such extrusion leads to the decomposition of the active substance, especially if the active substance is sensitive to oxidation or may react with other ingredients of the tablets.
A further advantage of the composition of the present invention is that the technical problems of discolouring of the tablets made therefrom and oxidation of the active substance may be avoided.
Moreover, it has further been shown that the particulate composition of the invention has improved storage stability compared to prior art products. It is believed that this fact is also due to the improved mechanical strength of the particles resulting in a reduced degradation of the active ingredient during storage.
In a preferred embodiment of the invention the fish gelatinous protective colloid contains at least 70% by weight, preferab

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