Since the early 1990's, the practice of compounding has been experiencing renewed popularity as the benefits of individualized drug therapy are recognized. In 2003, it was estimated that 30 million prescriptions yearly were compounded products; comprising 1% of all prescriptions dispensed.1 Today, pharmacists in many practice settings have the opportunity to compound extemporaneous preparations.
The Art, Science, and Technology of Pharmaceutical Compounding, now in its third edition, contains 29 chapters and 9 appendixes. A complete table of contents and index are also included. Over 200 formulations are included throughout the text. Each formulation lists ingredients and gives specific steps for preparing the product. A separate listing of all sample formulations is located at the front of the text.
The first 8 chapters of the text present an efficient overview and provide a quick reference on the following topics as related to compounding: guidelines, facilities, equipment, supplies, recordkeeping, product stability, calculations, quality control, flavors, sweeteners, colors, preservation, sterilization, and depyrogenation. Information new to this edition in these early chapters is limited and primarily reflects new and revised standards in terms of regulatory framework (Chapter 1), compounding ingredients (Chapter 2), and quality control (Chapter 6).
The strength of this reference continues to be the next 14 chapters (Chapters 9-22), which are dedicated to various types of dosage form preparations (ie, powders, granules, capsules, tablets, lozenges/troches, suppositories, inserts, sticks, solutions, suspensions, emulsions, ointments, creams, pastes, gels, ophthalmic, otic, nasal, inhalation, and parenteral). The chapters are detailed and share a common organizational format (as noted on each chapter's title page in “Chapter at a Glance”) including definitions, historical use, applications, preparation, physiochemical considerations, quality control, packaging, storage, labeling, stability, patient counseling considerations, and sample formulations for each specific dosage preparation. The vast majority of information presented in these 14 chapters, including the sample formulations, remains unchanged from the previous edition. A section on commercial bases used in compounding has been added to Chapter 18. New and revised standards have been included with parenteral preparations (Chapter 22). Also, the standard operating procedures (SOP) and documentation procedures have been removed from each individual chapter and are combined in one central location in Appendix II.
The next 3 chapters (Chapters 23-25) were included in the previous edition, but new sections have been included in this revision. For example, short sections on nanotechnology and pharmacogenomics have been added to Chapter 23. A section on phonophoresis including 6 sample ultrasound formulations has been added to Chapter 24, and information on veterinary transdermal therapy has been added to Chapter 25.
The most noticeable changes in this third edition include the timely incorporation of 4 new chapters: Compounding for Clinical Studies (Chapter 26), Compounding Cosmetics (Chapter 27), Compounding with Hazardous Drugs (Chapter 28), and Compounding for Terrorist Attacks and Natural Disasters (Chapter 29). Along with valuable information, 25 sample formulations are included in the Cosmetics chapter and 31 sample formulations are included in the Compounding for Terrorist Attacks and Natural Disasters chapter. In addition to these new chapters, there are 3 new appendices included in this edition that include information on using weight-related conversion factors, allowable endotoxin levels in parenteral preparations, and disinfecting agents used in compounding pharmacies.
The detail, magnitude, and scope of information presented and the very organized and methodical presentation format used throughout the text is impressive and makes this reference very user friendly. The overall strength of this reference is on extemporaneous product preparation of non-parenteral dosage forms. Revisions to this edition have been noted to inform those individuals with a second edition copy of specific changes to the reference. Overall, this reference is a valuable tool for pharmacists involved at any level with compounding, as well as instructors and doctor of pharmacy students involved with courses focused on non-parenteral extemporaneous preparations.
REFERENCES
- 1. Federal and State Role in Pharmacy Compounding and Reconstitution, U.S. Food and Drug Administration. Available at: http://www.fda.gov/ola/2003/pharmacycompound1023.html. Accessed March 20, 2009.