Formulations extemporaneous

Extemporaneous production of pediatric dosage forms is commonly undertaken in hospitals. Without the sophisticated formulation capabilities of pharmaceutical manufacturers, alcohol-based vehicles have been recommended for extemporaneous preparation of liquid dosage forms [73]. There is a critical need to conduct research studies to assist the pharmacist in replacing current formulations with stable, alcohol-free preparations [74]. 

All together, these findings have encouraged the development of neutral and cationic lipospheres (CLS) as nonviral DNA-mediated gene transfer techniques because CLS enable the extemporaneous production of pharmaceutical formulations. Like emulsions and liposomes, lipospheres (LS) consist of physiologically well-tolerated ingredients that have often already been approved for pharmaceutical use... 

A decision tree approach for reducing the time to develop and manufacture formulations for the first oral dose in humans has been described by Hariharan et al.86 and is reproduced in Scheme 3.1. The report summarized numerous approaches to the development and manufacture of Phase I formulations. Additional examples of rapid extemporaneous solution or suspension formulations for Phase I studies have been reported.87,88... 

Prescriptions requiring extemporaneous compounding by the pharmacist do not require the extended shelf-life that commercially manufactured and distributed products do because they are intended to be used immediately on their receipt by the patient and used only during the immediate course of the prescribed treatment. However, these compounded prescriptions must remain stable and efficacious during the course of their use and the compounding pharmacist must employ formulative components and techniques, which results in a stable product. ... 

The use of pharmaceutics and most of the pharmaceutical or physicochemical factors involved in formulation of these products are identical. One exception, however, is the shorter beyond-use dates assigned to compmmded preparations as compared to expiration dates for manufactured products. A second notable exception is that commercially manufactured products are developed over several years whereas an extemporaneously compounded preparation may be required for a specific patient in a matter of minutes or hours. 

What area of pharmacy practice has the opportunity of using the scientific education and training as much as pharmacists involved in individualizing patient care through extemporaneous compounding The pharmaceutical sciences, especially chemistry and pharmaceutics, serve as the foundation for pharmacists ability to formulate specific dosage forms to meet patients needs. 

Transdermal delivery of certain APIs is now common for the treatment of some medical conditions, and there are several excipients that are promoted as transdermal penetration enhancers. One of the earlier materials developed was laurocapram (Azone ). There is a detrimental interaction between laurocapram and mineral oil (liquid paraffin) whereby when both are included in the same formulation, the skin penetration-enhancing properties of laurocapram are lost. Such interactions have implications for extemporaneous mixing of different cream and ointment formulations in the pharmacy. 

In this book, a number of formulations for made-up suspensions or extemporaneous suspensions produced from instant granules or dry syrups... 

At times, extemporaneous addition of drug to a ready-to-use emulsion (e.g., L payaiy not be the preferred way of developing formulations. This can be explained in view of the following reasons ... 

An ICH photostability study was performed to investigate the rate and extent of photodegradation that may be anticipated for extemporaneous preparations of phenyl ether drug A formulations that contain TiO. The effect of incremental light exposure levels was examined for both visible and UV light by titrating the amount... 

From the theoretical background presented above, one can easily devise his or her own methods to adjust tonicity of solutions using the principles of colligative properties. However, in the practice of pharmacy, a number of simple methods to adjust tonicity of formulation in a prescription order on an extemporaneous basis were developed to help the pharmacist. The methods of adjusting tonicity could be classified into... 

Extemporaneous preparation of suspensions of drugs available commercially only in other dose forms is widely practised in hospital pharmacy, particularly for paediatric use. Dmgs such as acetazolamide, amiodarone and mercaptopurine are examples. In such formulations, alternatives to traditional suspending agents such as tragacanth should be examined. The ideal suspending agent should ... 

The inhalation of antimicrobial agents to treat infections in the lung has been of interest for decades [1], As early as the 1950s, extemporaneously prepared antimicrobial agents were aerosolized to treat pneumonia. These preparations were often crude and not well tolerated by patients. Dosage, formulation procedures, and stability assessment in these early reports were not consistent. Although some successes were reported, the potential benefit of this route of administration was not fully appreciated until the 1980s. 

Nahata, M.C. Morosco, R.S. Hippie, T.F. Stability of mexiletine in two extemporaneous liquid formulations stored under refrigeration and at room temperature. J. Am. Pharm. Assoc. 2000, 40 (2), 257-259. 

Burdick KH, Poulsen B, Place VA. Extemporaneous formulation of corticosteroids for topical usage. JAMA 1970 211(3) 462 66. 

Although new and iimovative formulations are urgently needed, work on extemporaneous formulations should not be disregarded, as this is stiU an activity of vital importance in many hospital pharmacies that collaborate with physicians in trials and who also work with orphan drugs. Hence the principles of formulation and manufacture espoused in this book are clearly relevant not only to those who work in industry but also to those who practice closer to the patient. 

A nnmber of extemporaneous formulations for oral, intravenons, and rectal administration are included in a compilation of prodncts for use in pediatric patients. A specific reference on the stability... 

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