TAP Pharmaceutical Products

Majid Vakily TAP Pharmaceutical Products, Inc., Lake Forest, Illinois, U.S.A. 

Loos R, Wollgast J, Huber T, Hanke G (2007) Polar herbicides, pharmaceutical products, perfluorooctanesulfonate (PFOS), perfluorooctanoate (PFOA), and nonylphenol and its carboxylates and ethoxylates in surface and tap waters around Lake Maggiore in Northern Italy. Anal Bioanal Chem 387 1469-1478... 

As noted in Chapter 7, Takeda initiated its first venture overseas by forming a ten-year, 50-50 joint venture with Abbott to develop and market new products in 1977 and 1987 its venture was renewed for another ten years. In 1997 TAP Pharmaceuticals became a full-fledged subsidiary of the Japanese company, responsible for the production and marketing organizations for the North American market. In 1998 a comparable subsidiary for Europe was established in Frankfurt, Germany. 

The biggest success of pol5mier controlled release systems in cancer therapy however has been in the area of prostate cancer treatment. This therapy is luiique since it uses a hormone-suppressant rather than a chemotherapeutic agent to minimize cancer cell growth in the prostate. Several products include Lupron Depot (TAP Pharmaceuticals), Zoladex (Astra-Zeneca), and Trelstar Depot (Debio RP, Pharmacia). Lupron Depot involves PLA microspheres, Zoladex formulation is an extruded rod, whereas Trelstar depot consists of PLGA microspheres, all of which incorporate LHRH analogues. 

Transient reactors, such as pulse (chromatographic) reactors, temporary analysis of products (TAP) reactors, multitrack reactors, and temperature-programmed reactors have been developed mainly to study gas-solid (catalyst) reactions. These are rather sophisticated techniques used to study mechanisms of catalytic processes at the molecular level in great detail. Since this is rarely done in the development of processes for the manufacture of fine chemicals and pharmaceuticals, these reactors are not discussed further. The interested reader is referred to works by Anderson and Pratt (1985) and Kapteijn and Moulijn (1997). 

Tablets and capsules Pharmaceutical ingredients Purified water Manufacturing environment Products Periodic after history is established accepted on supplier certificate of analysis Loop daily and taps weekly Quarterly Periodic after history is established due to low water activities of tablets and capsules...

Salt, sodium chloride classification compound. Stainless steel, mix of iron and carbon classification mixture. Tap water, dihydrogen oxide plus impurities classification mixture. Sugar, chemical name sucrose classification compound. Vanilla extract, natural product classification mixture. Butter, natural product classification mixture. Maple syrup, natural product classification mixture. Aluminum, metal classification in pure form—element (sold commercially as a mixture of mostly aluminum with trace metals, such as magnesium). Ice, dihydrogen oxide classification in pure form—compound when made from impure tap water—mixture. Milk, natural product classification mixture. Cherry-flavored cough drops, pharmaceutical classification mixture. 

Topicals, otics, vaginal and rectal products Pharmaceutical ingredients Purified water Manufacturing environment Products As above Loop daily and taps weekly Weekly or monthly Routine for products with high water activity periodic after history is established for product with low water activity... 

Injectable products, ophthalmic products, and inhalation solutions Pharmaceutical ingredients Purified water Manufacturing environment Products As above Loop and taps daily Every shift in critical aseptic processing areas Every batch with the exception of terminally sterilized products approved for parametric release... 

Water for use in manufacture has not always been recognised to be a starting material and as a consequence has been the source of many manufacturing problems internationally. Although tap water can be reasonably pure, it is always variable and in some regions of very poor quality by pharmaceutical standards. It is therefore necessary to substantially remove impurities and to control the microbial level in order to standardise products and avoid contaminating them. 

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