Product‐centered processing: Pharmaceutical tablets and capsules

Abstract

A systematic procedure is presented for synthesizing and de®eloping a manufacturing process for pharmaceutical tablets and capsules. The product quality factors ᎏ functional, physical and sensorial ᎏ are first identified. The dosage form and excipients are then selected, and the process flowsheet is synthesized along with the suitable equipment and operating conditions. Finally, the product and process are e®aluated to ensure that the product possesses the desired quality factors. Design heuristics and physical models are pro®ided to assist decision-making. Examples in®ol®ing Vitamin C, antacid, and ginseng are pro®ided to illustrate the procedure. IntroductionPharmaceuticals with global sales expected to reach $406 billion in 2002 constitute a significant fraction of the chemi-Ž . cal processing industries Bailey, 2000 . They are delivered in different dosage formsᎏsolids, liquids, creams, pastes, and Ž . aerosols. Since active pharmaceutical ingredients API are normally in the solid state, most common are solid dosage Ž . forms, particularly tablets and capsules Zanowiak, 1988a , which are convenient to use and provide precise dosage.There are a wide variety of tablets and capsules. While the majority are designed to be absorbed in the gastrointestinal tract, lozenges are expected to act on the mouth and throat. Most tablets are directly swallowed, but some are supposed to be chewed by children or elderly with swallowing difficulty. Effervescent tablets are dissolved either directly in the mouth or in water before ingestion. Prolonged release tablets and capsules provide an extended therapeutic effect.Despite the economic significance of solid dosage forms, relatively little has been done from the process systems engineering perspective. This is a serious omission because an effective workflow is expected to reduce the time and effort required for launching a product. Indeed, it is generally accepted that product engineering and solids processing de-Ž serves much more attention Tanguy and Marchal, 1996;Villadsen, 1997;Kind, 1999; Wintermantel, 1999;Cussler and . Ž . Moggridge, 2001 . Recently, Wibowo and Ng 2001b consid-Correspondence concerning this article should be addressed to Ka M. Ng. ered the integration of product design and process design for creams and pastes; customer preferences lead to desirable quality factors that are then achieved by properly designing the process. This article presents such a product-centered systematic procedure for the synthesis and development of tablet and capsule manufacturing processes. Systematic Procedure Ž .There are 4 steps: 1 Identification of product quality fac-Ž . Ž . tors, 2 Product formulation, 3 Design of manufacturing Ž . process, and 4 Product and process evaluation. Design heuristics and physical models are presented to assist decision-making in each step.Step 1: identification of product quality factors Product quality factors other than therapeutic effects can be divided into functional, physical, and sensorial. For pharmaceuticals, the primary concern...

Purdue Ontology for Pharmaceutical Engineering: Part I. Conceptual Framework

“…In drug products (composed of multiple compounds), materials frequently have roles to play (what the material contributes to the drug product). These roles could include being an API, assisting flow (flow aid) among others [14].…”

Design of formulated products: A systematic methodology

“…8 Formulations can also have other physical forms. 9 For example, suspensions contain insoluble chemicals dispersed in the liquid with the help of a dispersant; creams [10][11] are emulsions where solid constituents have been emulsified through selected emulsifiers together with solvents and additives; solid products such as pharmaceutical tablets 12 or soap bars are at the solid state. Because a single chemical (molecule) is unlikely to satisfy the multiple needs, a blend of several chemicals is usually sought.…”

Design of formulated products: Experimental component

“…Wibowo and Ng 10 developed a procedure for the manufacture of creams and pastes, which was subsequently generalized for chemical-based consumer products. 11 Fung and Ng 12 presented a systematic procedure for the manufacture of tablets and capsules. Cheng et al 13 formulated an approach, which involves business and management decisions in product development.…”