Claims
- 1. A granulated product containing granules of an active ingredient endowed with therapeutic/nutritional activity and a pharmacologically acceptable granulating/bonding agent, said granulated product being suitable for conversion into solid administration forms by means of a direct compression procedure, or for constituting the content of capsules, wherein said product consists of:(a) from 92 to 96% by weight, calculated in relation to the weight of the granulated product, of an active ingredient selected from the group consisting of L-carnitine inner salt, an alkanoyl L-carnitine inner salt, in which the straight- or branched-chain alkanoyl group has 2-6 carbon atoms, or one of their pharmacologically acceptable salts; and (b) from 4 to 8% by weight, calculated in relation to the weight of the granulated product, of a granulating/bonding material selected from the group consisting of polyvinylpyrrolidone, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxybutyl-cellulose, polyethyleneglycol, microcrystalline cellulose, cellulose acetate phthalate, methylcellulose, ethylcellulose, polyvinylalcohol, styrene maleic anhydride, and mixtures thereof.
- 2. A granulated product containing granules of an active ingredient endowed with therapeutic/nutritional activity and a pharmacologically acceptable granulating/bonding agent, said granulated product being suitable for conversion into solid administration forms by means of a direct compression procedure, or for constituting the content of capsules, wherein said product consists of:(a) from 92 to 96% by weight, calculated in relation to the weight of the granulated product, of an active ingredient selected from the group consisting of L-carnitine inner salt, an alkanoyl L-carnitine inner salt, in which the straight- or branched-chain alkanoyl group has 2-6 carbon atoms, or one of their pharmacologically acceptable salts; (b) from 4 to 8% by weight, calculated in relation to the weight of the granulated product, of a granulating/bonding material selected from the group consisting of polyvinylpyrrolidone, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxybutyl-cellulose, polyethyleneglycol, microcrystalline cellulose, cellulose acetate phthalate, methylcellulose, ethylcellulose, polyvinylalcohol, styrene maleic anhydride, and mixtures thereof; and (c) from 0.1 to 1% of amorphous silica by weight, calculated in relation to the weight of the granulated product.
- 3. A tablet obtained by direct compression of the granulated product according to claim 1 or 2.
- 4. A capsule containing the granulated product according to claim 1 or 2.
- 5. A granulated product according to claim 1 or 2 consisting of:(a) from 94 to 96% of L-carnitine inner salt by weight, calculated in relation to the weight of the granulated product; and (b) from 4 to 6% of polyvinylpyrrolidone by weight, calculated in relation to the weight of the granulated product.
- 6. A granulated product according to claim 1 or 2 consisting of:(a) from 94 to 96% of L-carnitine inner salt by weight, calculated in relation to the weight of the granulated product; (b) from 4 to 6% of polyvinylpyrrolidone by weight, calculated in relation to the weight of the granulated product; and (c) from 0.4 to 0.6% of amorphous silica granulate by weight, calculated in relation to the weight of the granulated product.
- 7. A granulated product according to claim 1 or 2, in which the alkanoyl L-carnitine inner salt is selected from the group consisting of acetyl L-carnitine inner salt, propionyl L-carnitine inner salt and isovaleryl L-carnitine inner salt.
- 8. A granulated product according to claim 1 or 2, in which the pharmacologically acceptable salt of L-carnitine or of the alkanoyl L-carnitine is selected from the group consisting of their fumarates, tartrates and chlorides.
- 9. A granulated product according to claim 1 or 2, in which the active ingredient contains acetyl L-carnitine chloride.
- 10. A tablet obtained by direct compression of the granulated product according to claim 7.
- 11. A capsule containing the granulated product according to claim 7.
Priority Claims (1)
Number |
Date |
Country |
Kind |
RM99A0189 |
Mar 1999 |
IT |
|
Parent Case Info
This is a continuation of application No. PCT/IT00/00097, filed Mar. 22, 2000.
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EP |
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EP |
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GB |
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Entry |
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Continuations (1)
|
Number |
Date |
Country |
Parent |
PCT/IT00/00097 |
Mar 2000 |
US |
Child |
09/962605 |
|
US |