Geoffrey D. Tovey - Specialised Pharmaceutical Formulation: The Science and Technology of Dosage Forms

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Drug Discovery Series No. 2

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Specialised Pharmaceutical Formulation

The Science and Technology of Dosage Forms

Specialised Pharmaceutical Formulation

The Science and Technology of Dosage Forms

Edited by

Geoffrey D. Tovey

King's College London and Geoff Tovey Associates, UK
Email:

Drug Discovery and Pharmaceutical Science Series

Editor-in-chief:

Ved Srivastava, Global Peptide Science Institute (GPSi), USA

Series editors:

Kendal Pitt, Glaxo SmithKline PLC, UK

Geoffrey D. Tovey, King's College London and Geoff Tovey Associates, UK

Titles in the Series:

1: Implantable Technologies: Peptides and Small Molecules Drug Delivery

2: Specialised Pharmaceutical Formulation: The Science and Technology of Dosage Forms

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Dedication

For Katherine, Christopher and Caroline lights of my life

Preface

Pharmaceutical formulation is an essential part of new product development but is often given less attention than it deserves in books on pharmaceutical development. The approach to the subject in this book is to focus on the dosage form being developed from the point of view of how it is given to the patient rather than other specifics such as the drug substance or particular patient condition to be treated. Accordingly, there are chapters on dosage forms for particular routes of administration such as the eye, injections directly into the body, access via the skin and the lung as well as various oral dosage forms, the latter including oral films, oral suspensions and drug powder sachets.

In each case there are special features and requirements to be taken into considerationhence the title Specialised Pharmaceutical Formulation.

In addition to the above, there are other chapters that cover the particular challenges of ensuring that the medicines will be acceptable to patients. One such chapter covers the sensory characteristics of the products including taste, texture, ease of swallowing and other features which may influence whether the patient will comply with the dosage instructions given by the prescribing physician.

A chapter on the particular needs of the geriatric population is included as also is a chapter on the additional factors which apply when dosage forms are made which contain a combination of more than one active pharmaceutical ingredient.

All the chapters have been written by experts in the various subject fields and are currently based on either manufacturing industry or academia. Many have experience in both areas and have the knowledge to judge practicalities for production and administration to patients.

In previous times, the background education of formulators was a pharmacy degree, and the expertise was very much confined to pharmacists. For a variety of reasons, the formulation scientists of today come from a much wider range, including many different chemistry and biological sciences. As the trend continues towards larger molecular active ingredients of biological origin, this much broader catchment of skills is now essential to bringing new medicinal entities to patients.

Throughout this book the intention is to ensure that the information given is both practical and applicable to large-scale manufacture. Some new technologies and applications are included, but care has been taken to avoid too much early-stage research and futuristic possibilities: unimaginable developments are without doubt ahead of us as the future is not what it used to be. However, other sources should be consulted for such speculation.

Having said this, I have included in the book one or two chapters on new approaches which are a reality and likely to figure much more prominently in the future. One is on advanced therapy medicinal products, where cells and genes are used to provide currently unmet clinical needs.

Another is in the area of dermal delivery where microneedle arrays are used as a route for the transdermal drug delivery of high molecular weight molecules, including proteins and vaccines. Without needles and syringes or the need to visit a hospital, it is possible to imagine the value of such dosage forms in the fight against future pandemics, especially in the developing world. The chapter on transdermal drug delivery explains this in detail.