Industrial pharmaceutical technology

R. Jones, Excipient effects on topical drug delivery paper presented at the Industrial Pharmaceutical Technology Section Symposium, 121st Annual Meeting of the American Pharmaceutical Association, Chicago, Abstracts, Vol. 4, p. 24. 

W. E. Claxton, paper presented to the Industrial Pharmaceutical Technology Section, American Pharmaceutical Association, Academy of Pharmaceutical Sciences, San Francisco meeting, Mar. 1971. 

Industrial Pharmaceutical Technology (IPT) Type B tooling with a known punch head flat as a standard for press speed comparisons. 

Consequently, we consider that the industrial scale technological management of microwave assisted chemical reaction is no compatible with batch reactors coupled with multimode applicators. Some typical processes with a systematic decrease of the dielectric losses of the concerned reactant, such as filtration and drying of mineral or pharmaceutical powders are compatible with multimode applicators. To our knowledge, the only industrial batch microwave device is the microwave variant of the Turbosphere ( all in one solution mixer/granulator/dryer designed by Moritz... 

U.S. International Trade Commission. 1991. Global competitiveness of U.S. advanced-technology manufacturing industries Pharmaceuticals. Report to the Committee of Finance, U.S. Senate, on Investigation No. 332-302 Under Section 332(g) of the Tariff Act of 1930. 

Kirsch, R. B., Validation of Analytical Methods Used In Pharmaceutical Cleaning Assessment and Validation Analytical Validation in the Pharmaceutical Industry, Supplement to Pharmaceutical Technology pp. 40 6, 1998. 

For the above-described reasons, molecular spectroscopic techniques have become the most common choices for pharmaceutical analysis in addition to chromatography. The latter, however, are being gradually superseded by the former in some industrial pharmaceutical processes. Recent technological advances have led to the development of more reliable and robust equipment. The ubiquity of computers has enabled the implementation of highly powerful chemometric methods. All this has brought about radical, widespread changes in the way pharmaceutical analyses are conducted. 

The ABPI examinations for medical representatives and generic sales representatives are based on a syllabus published by the ABPI which covers, as appropriate, subjects such as body systems, disease processes and pharmacology, the classification of medicines and pharmaceutical technology. Information on the National Health Service and pharmaceutical industry forms an additional core part of the syllabus. The syllabus is complementary to, and may be incorporated within, the company s induction training which is provided to representatives as a pre-requisite to carrying out their function. 

The ABPI Code of Practice, in line with European Directive 75/319/EEC, calls for an efficient transfer of information on adverse drug reactions. In the case of defective medicines, an ABPI Batch Recall of Pharmaceutical Products system is in operation. In the ABPI Expanded Syllabus, batch recall is referred to in the Pharmaceutical Technology section and adverse drug reactions in the Pharmacology and Classification of Medicines and the Pharmaceutical Industry and the NHS sections. 

Robert P. Cogdill, Duquense University Center for Pharmaceutical Technology, Pittsburgh, Pennsylvania, Case for Process Analytical Technology Regulatory and Industrial Perspectives... 

Reisch, R. G., Chapman, K. G. Process validation—industry s viewpoint. In Pharmaceutical Technology Conference 84 Proceedings. Springfield, OH Aster, pp. 92-101 (1984). 

Another professional organization headquartered in central Europe, APV (International Association for Pharmaceutical Technology, Mainz, Germany), developed the topic further in two seminars in Gelsenkirchen in late 1981 and early 1982 [6]. Speakers from industry demonstrated how validation could be applied to industrial activities and how a balance between resources allocation and results could be achieved. Oral dosage forms, topicals, and sterile products, as well as analytical methods during development, transfer, and production phases were discussed. 

One indication of the developing interest in PATs in the pharmaceutical area is the number of book chapters and review articles in this field that have appeared in the last few years. Several chapters in The Handbook of Vibrational Spectroscopy3 are related to the use of various optical spectroscopies in pharmaceutical development and manufacturing. Warman and Hammond also cover spectroscopic techniques extensively in their chapter titled Process Analysis in the Pharmaceutical Industry in the text Pharmaceutical Analysis.4 Pharmaceutical applications are included in an exhaustive review of near-infrared (NIR) and mid-infrared (mid-IR) by Workman,5 as well as the periodic applications reviews of Process Analytical Chemistry and Pharmaceutical Science in the journal Analytical Chemistry. The Encyclopedia of Pharmaceutical Technology has several chapters on spectroscopic methods of analysis, with the chapters on Diffuse Reflectance and Near-Infrared Spectrometry particularly highlighting on-line applications. There are an ever-expanding number of recent reviews on pharmaceutical applications, and a few examples are cited for Raman,7 8 NIR,9-11 and mid-IR.12... 

The focus of this work is on chemical industry. Pharmaceutical production is included in the definition of chemical industry because the production technologies employed are very similar to those in chemical industry. Within chemical industry Kline (1976, pp. 110-113) suggests to define the four sub-segments also shown in Figure 7. 

Many different products are now purified by chromatographic processes, from the laboratory scale (a few grams) up to the industrial pharmaceutical scale (a few tons per year) or even up to the petrochemical scale (100,000 tons per year). Among the possible technologies, the elution high-performance liquid chromatography (HPLC) technology (sometimes with recycle) has taken a very important part of the small-scale (10 tons per year) market... 

Applications of HPLC Of the bioanalytical separation technologies described in this book, arguably HPLC has the widest range of applications, being adopted for the purpose of clinical, environmental, forensic, industrial, pharmaceutical and research analyses. While there are literally thousands of different applications, a few indicators of how HPLC has been used are as follows (i) Clinical quantification of drugs in body fluids (ii) Environmental identification of chemicals in drinking water (iii) Forensic analysis of textile dyes (iv) Industrial stability of compounds in food products (v) Pharmaceutical quality control and shelf-life of a synthetic drug product (vi) Research separation and isolation of components from natural samples from animals and plants. 

The individual self-contained volumes will each encompass a closely related field of applications and will demonstrate those methods which have found the widest applications in the area. The emphasis is expected to be on the comparison of published and established methods which have been employed in the application area rather than the details of experimental and novel methods. The volumes will also identify future trends and the potential impact of new technologies and new separation methods. The volumes will therefore provide up-to-date critical surveys of the roles that analytical separations play now and in the future in research, development and production, across the wide range of the fine and heavy chemical industry, pharmaceuticals, health care, food production and the environment. It will not be a laboratory guide but a source book of established and potential methods based on the literature that can be consulted by the reader. 

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