A Novel Compression-Coated Tablet Dosage Form

www.pharmtech.com new chemical entity often is first formulated as a free-flowing granulation for encapsulation within hard gelatin capsules. During the course of clinical development, the drugcontaining granulation usually is modified for compaction into a tablet product. The tablet product subsequently may be film coated for taste masking, identification, or other purposes. Tablets are the most preferred and widely used dosage form because of their ease of administration, lower cost of manufacture, and elegance. In this article, we describe a means of producing tablet dosage forms (specifically, compression-coated tablets) from granulations or blends that do not readily form a compact. The compression-coating granulation or blend can be preformulated to provide desired functionalities to the coating. The only requirement for producing the compression-coated tablet dosage form described herein is that the core material should possess the ability to flow into a die during production. The method described may be used to produce compression-coated tablet dosage forms with minimal formulation development work. Most important, the equipment used for producing these compression-coated tablets is based on simple modifications of a traditional three-layer tablet press. Modern compression-coated products are made on specialized equipment in two separate operations: manufacture of core tablets on a traditional tablet press and the subsequent application of a compression-coating granulation. The compression-coating production process requires relatively complex machinery to encapsulate the core tablet within an outer granulation. The use of a Colton 232 tablet press is another slightly different method of making compressionA Novel Compression-Coated Tablet Dosage Form