Pharmaceutical products formula

Cui Y. Song X. Chuang K. Venkatramani C. Lee S. Gallegos G. Venkateshwaran,T. Xie, M. Variable selection in multivariate modeling of drug product formula and manufacturing process. Journal of Pharmaceutical Sciences, 2012, in press. 

In order to develop a robust formula for a drug product (pharmaceutical dosage form) it is important to understand the chemical and physical properties of the API in conjunction with excipients that may be used to create the most stable product formula in terms of activity and potency. An outline of possible preformulation studies that should be conducted to ensure a proper and complete understanding of the chemical and physical properties of the API is presented in Table 3. 

This approach to validation is normally undertaken whenever the process for a new formula (or within a new facility) must be validated before routine pharmaceutical production commences. In fact, validation of a process by this approach... 

Pharmaceutical products have been manufactured into compressed tablets for many years. During the 1950s, much research was devoted to the physics of compression.f Since that time, the pharmaceutical industry has attained a much greater understanding of the compression process, which resulted in the development of more robust pharmaceutical formula-tions. This has been achieved by the use of instrumented tablet presses and sophisticated data collection systems combined with the development of mathematical models. 

The applicant must apply for permission to manufacture or import a pharmaceutical product as a sample for registration the information on the labels and inserts must also be submitted to the FDA. In the case of a pharmaceutical product which is not yet registered in Thailand, a certificate of free sales issued by the country of origin is required. The same criteria are applied to new formulas or new combination pharmaceutical products. 

Quality Conformity of a pharmaceutical product with its formula and specifications and conformity of its production and of its control with the basic standards of good manufacturing practice. Quarantine The status of a material which may not be used until released. 

With respect to any drug or pharmaceutical products identified, readers are advised to check the most current information provided (i) on procedures featured or (ii) by the manufacturer of each product to be administered, to verify the recommended dose or formula, the method and duration of administration, and contraindications. It is the responsibility of practitioners, relying on their own experience and knowledge of their patients, to make diagnoses, to determine dosages and the best treatment for each individual patient, and to take all appropriate safety precautions. 

In most pharmaceutical situations, however, there is often insufficient latitude in the formula or process to allow the necessary experimentation. The pharmaceutical industry is subject to regulatory constraints that make EVOP impossible to employ in validated production processes and, therefore, impractical and expensive to use. Moreover, EVOP is not a substitute for good laboratory-scale investigation and, because of the necessarily small changes utilized, is not particularly suitable to the laboratory. In pharmaceutical development, more efficient methods are desired. 

In most cases, ointments, suppositories, ophthalmic, and parenteral products assume the color of their ingredients and do not contain color additives. In addition to esthetics and the certification status of a dye, a formulation pharmacist must select the dyes to be used in a particular formula on the basis of the physical and chemical properties of the dyes available. Of prime importance is the solubility of a prospective dye in the vehicle to be used for a liquid formulation or in a solvent to be employed during a pharmaceutical process (such as when the dye is sprayed on a batch of tablets). In general, most dyes are broadly grouped into those that are water-soluble and those that are oil-soluble few, if any, dyes are both. 

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