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THE PHARMA REVIEW (MAY 2010)

Control Release Pellets and Its Technique

Shridhar J Pandya, Samip S.Shah, Pagada Parthesh K, Pinal S. Patel

Introduction
Traditionally, the word “pellet” had been used to describe a variety of systematically produced, geometrically defined agglomerates obtained from diverse starting materials utilizing different processing conditions. Pellets are of great interest to the pharmaceutical industry for a variety of reasons and these products not only offers flexibility in dosage form design and development but also utilized to improve the safety and efficacy of bioactive agents. Pellets are a multi-particulate, solid form of medication. The individual pellets are almost spherical with diameter ranges 100-2000 micrometer.1 Pelletization is an agglomeration process that converts fine powders or granules of bulk drugs and excipients in to small, free flowing, spherical or semi-spherical units (referred to as pellets) using appropriate processing equipment. These agglomerates include fertilizers, animal feeds, iron ores, and pharmaceutical dosage units and thus do not only differ in composition but also encompass different sizes and shapes. Pellets are also used to provide the pharmaceutical scientist with tremendous flexibility during the development of oral dosage forms. Pellets composed of different drug entities can be blended and formulated in a single dosage form. This approach has numerous advantages. Pellets can be divided into desired dosage strength without formulation or process changes and also can be blended to deliver incompatible bioactive agents simultaneously and/or to provide different release profiles at the same or different sites in gastrointestinal (GI) tract. In addition, pellets, taken orally, disperse freely in the GI tract, maximize drug absorption, minimize local irritant drugs and reduce intra- and inter patient variability of plasma profiles, which are common with single unit regimens. When formulated as modified release dosage forms, pellets are less susceptible to dose dumping than the reservoir-type single unit formulations. In addition, pellets have an enough surface area-to-volume ratio and hence provide an ideal shape for the application of film coatings.2 As pellets flow and pack freely, it is not difficult to obtain uniform and reproducible fill weights in capsules, provided that the size and densities are favorable. Pellets can also be made attractive due to the various shades of color that can easily be imparted to them during manufacturing process. As the application of pellets in the development of oral dosage forms increases, basic principles governing pellet formation and growth should be studied thoroughly. Due to their unique properties and flexibility of manufacturing involved, pellets are expected to continue to play a major role in the fabrication of solid dosage forms. Many generic companies have already shown an interest in pellets for the development of superior line extensions of existing products that suffer from taste-masking problems. The antibiotic market also provides a target for this technology. E.g. Macrolide antibiotic was recently introduced into the market as pellet formulation. The purpose of this chapter is to study the importance of pharmaceutical development and production of drug pellets, possible formulation variables during the pellets formulation; technologies and equipment involved in the fabrication of pellets and various applications of the pellets.

 

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