Leo Pavliv and James F Cahill

Dosage Form Decisions 202

Formulation Development 205

Early Manufacturing 214

Process Development 216

General References 221

The culmination of many years of research, development, animal testing, clinical studies, and mountains of paper or many gigabytes of memory eventually result in a patient taking a tablet, inhaling a powder, or taking some other formulation of a drug product to alleviate or cure a malady. This chapter focuses on the steps entailed to create the actual product, the formulation, which a patient takes for his or her malady, from initial concept through commercial sale.

There are many critical decisions to make in defining the desired product parameters, such as conducting the necessary studies to ensure the product is safe and effective, that it can be consistently manufactured at the desired scale, it is a cost-effective treatment, and the final form of the product is ready and acceptable for patient consumption. The choice of formulation will impact significantly all the other parameters, including efficacy, safety, manufacturing, and cost. Pharmaceutical scientists lead this effort at a company, working closely with the discovery scientists, clinical operations medical staff, manufacturing scientists and managers, marketing managers, and regulatory managers, among others, to devise the best possible formulation for patients and providers, at a reasonable cost for the company and the health care system.

This chapter addresses ten topics important in creating a product and its formulation as listed in above. The topic "dosage form decisions" reviews the possible product forms, product profile, route and dose, decision makers, changes during development, and post approval changes. "Formulation development" covers overall goals, active ingredients, preformulation issues, bioavail-ability and pharmacokinetics, and the seven product categories

(oral, inhalation, injection, ophthalmic, topical, rectal, and vaginal). Six additional major issues in manufacturing and formulation of pharmaceutical products are discussed, including analytical development, process development, packaging, product stability, clinical supplies, scale-up issues, and commercialization requirements. The manufacturing and pharmaceutics groups at a company must consider all these issues for a successful IND/CTA and NDA/CTD, as well as acceptance by health care providers and patients and commercial success.

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Project Management Made Easy

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