Takeda Chemical Industries, Inc.

Seiji Izuhara

Yoshitomi Kakiguchi

Nobuyuki Kitamori

Masaya Maeno

Tatsuo Asogawa

Yasuhiko Morita

Kunihiko Yokota

A method of producing .beta.-form thiamine hydrochloride crystals which comprises moistening .alpha.-form thiamine hydrochloride crystals in the presence of .beta.-form thiamine hydrochloride crystals as seed crystals and stirring the mixture and a method of producing pharmaceutical preparations containing .beta.-form thiamine hydrochloride crystals which comprises moistening .alpha.-form thiamine hydrochloride crystals, together with a binder, with water in the presence of .beta.-form thiamine hydrochloride crystals as seed crystals and stirring the mixture. .beta.-Form thiamine hydrochloride crystals which are stable and resistant to caking and pharmaceutical preparations containing the same can be produced in a simple and easy manner.

Production of .beta.-form thiamine hydrochloride crystals

A composition which consists of a compound belonging to the Vitamin B group and having a solubility in water at 20.degree. C. of not more than 5%, and mannitol, is stable in itself and undergoes less influence under ambient humidity conditions. Its good flowability is retained during storage, only with very small changes, if any.

Composition of a B vitamin and mannitol and a method for production

The bath preparation of the present invention comprises an ascorbic acid compound and at least one reducing agent selected from the group consisting of water-soluble thiosulfate, water-soluble dithionite, L-cysteine hydrochloride, glutathione and gallic acid ester.

Bath preparation

A vitamin-containing granule comprising one or more compounds selected from the group consisting of vitamin B.sub.6, vitamin B.sub.2, nicotinamide and a pantothenic acid salt, and a binding agent, said compound or compounds accounting for 90 to 99 weight percent of the granules on the dry basis, can be prepared by spray-coating the powders of said compound or compounds with a solution containing a binder while maintaining the powders in a fluidized state in a fluidized-bed granulation apparatus. The granules are highly flowable and blend well with other medicaments, granules, additives, and so on. In addition to this, the granules are excellent in compressibility so that they can be processed into tablets with small amounts of excipients, and the tablets therefrom have satisfactory high hardness.

Vitamin-containing granules and production thereof

Granules consisting of a thiamine salt and a binder such as water-soluble celluloses, said thiamine salt accounting for about 95 to about 98 percent by weight on the dried basis, can be prepared by spray-coating thiamine salt powder at least about 95 percent by weight of which is capable of passing through a 145-mesh sieve with a solution containing a binder while maintaining said thiamine salt powder in a fluidized state in a fluidized-bed granulation apparatus. The granules are excellent in flowability, mixability, compressibility and bonding properties, and can be used for tablet manufacturing.

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Tondabayashi, Japan

Seiji Izuhara