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 consideration—hence 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.
It is hoped that this pragmatic approach will encourage formulators and other interested readers to make use of the in-depth knowledge and information given in the book about how things are done today.
In compiling this book, I have had the benefit of frequent valuable discussions with colleagues and must particularly acknowledge three people who have provided invaluable help to me: Dr Kendal Pitt, Dr Christian Seiler and Dr Marshall Whiteman. I am particularly grateful for their consistent interest and enthusiasm as well as their creative ideas. All have provided essential input to the planning, content and applicability of the subject matter as well as being always on hand to keep the necessary focus to ensure continued progress and help bring the volume to fruition.
My thanks also go to all the authors of the chapters for their time and commitment to produce such high-quality contributions for the book.
I must of course also thank the Royal Society of Chemistry who have continued to be highly supportive, and I am grateful for their enlightened awareness by publishing in this area of science and technology.
Finally, I should not overlook to mention that for the entire time the book was being created the world was suffering from the COVID-19 pandemic with all the additional challenges in communication and other constraints which have accompanied it.