Miles Inc.

Bayer Corporation

Miles Laboratories, Inc.

Lawrence J Daher

Thomas A Alexander

Donald L Peterson

Clarence L Hancock

Manley A Paulos

Gerald Gold

Lonnie C Sackman

Thomas P Callahan

Robbie L Hayward

Steven M Lonesky

Victor A Raul

George C Hoss

This invention provides a coating composition in which the principal film former is gelatin for use in coating tablets. The gelatin coating may be used with tablets, with or without any subcoating, and may be applied using conventional equipment. For a subcoated tablet, the coating formulation contains gelatin, a surfactant and a drying agent.

Gelatin spray coating

The invention provides a number of new water soluble lubricants and lubricant formulations which facilitate the production of tablets. In particular calcium and potassium sorbates and micronized combinations of polyethylene glycol with calcium ascorbate or with trisodium citrate or mixtures thereof are useful as lubricants, particularly in tablet compositions containing ingredients where rapid dissolution in an aqueous environment is desired for activity or desired for aesthetic purposes. A method is provided for surface treating calcium sorbate with docusate sodium, Simethicone Emulsion, USP or with lecithin to provide particularly useful tablet lubricants. The above lubricant(s) and lubricant formulations have fewer limitations and improved functionality in comparison to standard lubricants presently known. In addition, the lubricant(s) provided may be used with known hydrophobic lubricants to decrease the amount of the hydrophobic lubricant required for lubrication.

Lubricants for use in tabletting

The invention provides a coated tablet, a coating composition and a method of film coating. The coating is particularly useful for pharmaceutical tablets. The coating composition is composed of an aqueous solution of film forming inorganic salts which may be used with conventional coating techniques. Such film forming salts include sodium polyphosphate and sodium sulfate. This coating may be used on uncoated tablet cores, as a final coating or used as a subcoating for other coatings, such as enteric coatings. Use of this coating composition provides savings in cost of materials and in manufacturing efficiency over previous polymeric cellulose coatings.

Salt coated tablet

Hydrolyzed gelatin has been found to provide an improvement in taste and mouthfeel when incorporated in small amounts into chewable tablets containing ingredients requiring taste masking. Medicinals and nutritional supplements may now be prepared as chewables for those who find tablets difficult to swallow, for example children and older adults, or for those who prefer the convenience. There is a particularly large improvement in the taste and mouthfeel of chewables incorporating magaldrate and/or calcium carbonate.

Hydrolyzed gelatin as a flavor enhancer in a chewable tablet

Hydrolyzed gelatin as a flavor enhancer in a chewable table

The invention discloses a swallow tablet which is capable of disintegrating within less than about fifteen minutes and providing fast delivery of therapeutic drugs. The delivery system is composed of between 0.250 and 1.0 Gm of an alkali metal or alkaline-earth metal salt of an edible organic acid. A preferred delivery system is trisodium citrate.

Delivery system for enhanced onset and increased potency

The invention discloses an aqueous granulating solution containing sodium, potassium or mixed sodium potassium salt of an edible organic acid selected from the group consisting of citric, malic, tartaric and fumaric acid and optionally containing sodium or potassium bicarbonate. The granulating solution is especially useful for granulating finely divided solids including acetaminophen, ketoprofen or calcium carbonate. The resulting granulate may be used to prepare a swallow tablet or mixed with an edible organic acid and the mixture tableted to provide an effervescent tablet without resorting to controlled reaction or special handling techniques.

Aqueous granulation solution and a method of tablet granulation

A method for producing a tablet shine coating by either (a) alternately spray flooding the surfaces of tablets with a clear aqueous coating solution which is devoid of plasticizers, such as a solution consisting essentially of about 6% hydroxypropyl methylcellulose, about 0.06% sodium hexametaphosphate and about 0.006% lecithin by weight in water, and flash drying the tablets, or (b) alternately spray flooding the surfaces of coated tablets with water and flash drying the tablets.

Method for producing a shine coating by aqueous spraying and flash drying

The invention involves a granulating composition composed of an aqueous solution of magnesium sulfate heptahydrate and sodium hexametaphosphate. This composition can be used to prepare granules of ingredients for inclusion in any formulation for which rapid disintegration or dispersion are important factors. It is useful for tablets containing ingredients which are difficult to compress and is particularly useful for formulating swallowable tablets of a single non-soluble ingredient such as calcium carbonate. Disintegration times are markedly decreased.

Method of preparing oral dosage forms with a granulating composition

Granulating composition and method

A method and composition for providing aspartame as a sweetener in effervescent calcium ion-generating systems is provided. The method includes a step for providing a selected surfactant in association with the aspartame sweetener, to provide for aqueous solution of the aspartame in the presence of the solubilized calcium without film formation and without excessive foaming. Preferably, the aspartame/surfactant is provided by a granule composition, utilized in association with a calcium carbonate/citric acid effervescent couple.

Method for solubilization of aspartame in effervescent aqueous systems;

Nonaqueous solution of a tetracycline antibiotic salt which is stable upon extended storage comprises a mixture of a tetracycline antibiotic salt, nonaqueous diluent, nonaqueous solvent, and nonaqueous nonionic solubilizer. It preferably also contains an antioxidant and a nonaqueous anionic solubilizer.

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Elkhart, IN, United States of America

Lawrence J Daher