Miles Inc.

Bayer Corporation

Miles Laboratories, Inc.

L. Perrigo Company

Thomas A Alexander

Lawrence J Daher

Donald L Peterson

Clarence L Hancock

Gerald Gold

A process for uniformly distributing a pharmaceutically active particulate material in a pharmaceutically inert particulate material includes steps of providing a first layer of a pharmaceutically inert particulate material, disposing a layer of a pharmaceutically active particulate material on the first layer of pharmaceutically inert particulate material, passing the layers of particulate material through a static mixer, and discharging the blended mixture from the static mixer. The process is particularly useful for blending a low dose, high potency drug having a propensity to stick to process equipment surfaces with pharmaceutically inert particulate materials, such as diluents and/or excipients.

Method for distributing a pharmaceutically active compound in an excipient

The invention provides a new water soluble lubricant combination which facilitates the production of tablets. The combination of glyceryl behenate and fumaric acid is useful as a lubricant, particularly in tablet compositions containing ingredients where rapid dissolution in an aqueous environment is desired for activity or desired for aesthetic purposes. This lubricant combination has fewer limitations and improved functionality in comparison to standard lubricants presently known. In addition, the lubricants provided may be used with known hydrophobic lubricants to decrease the amount of the hydrophobic lubricant required for lubrication.

Lubricants for use in tabletting

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 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;

Described is a directly compressible formulation comprising calcium carbonate, citric acid, and a compression vehicle. In the preferred embodiment, the compression vehicle comprises a maltodextrin and lactose. The formulation can be compressed into an effervescent tablet system, which when placed in water effervesces in a relatively rapid dissolution releasing CO.sub.2 and resulting in a solution of monocalcium citrate.

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South Bend, IN, United States of America

Thomas A Alexander