Dosage forms

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  • Mechanical properties of film coats Michael E.Aulton SUMMARY This chapter discusses the need for a film coat to possess the correct mechanical properties. One of the requirements of a film coat is that it should provide adequate protection to the dosage form. The capacity of the film coat to afford physical protection depends to a large extent on its mechanical characteristics. After considering those desirable properties, the chapter explains how to assess such properties. It also explains the need for a standardized approach to film preparation prior to testing.

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  • The chapter commences with a brief introduction to the technique of sugar coating, which includes a note on the advantages and disadvantages of this method of coating. The various sequential steps involved in sugar coating are covered in some detail, i.e. sealing, subcoating, smoothing, colour coating, polishing and printing. In the section dealing with subcoating several suitable formulations are provided with details regarding application. Traditionally the colour-coating step in sugar coating has received much attention as the aesthetics of this dosage form are most important.

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  • Analytical technology transfer and manufacturing is the mechanism by which knowledge acquired about a process for making a pharmaceutical active ingredient or dosage form during the clinical development phase is transferred from research and development to commercial scale-up operation or shared between internal groups or with third parties. Analytical technology transfer guarantees that laboratories can routinely execute tests, obtain acceptable results, and be able to accurately and independently judge the quality of commercial batches.

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  • It has been over eight years since the first edition of the Handbook of Pharmaceutical Granulation Technology was published. The enthusiastic reception afforded by the scientific community was heartwarming. The basic science of granulation has not changed much over the last few years; however, a better understanding of the theory of granulation and the proliferation of different dosage forms has.

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  • Drug Administration be very precise. (Standardized medicinal teaspoons and tablespoons are available.) Eye drops and nose drops (A) are designed for application to the mucosal surfaces of the eye (conjunctival sac) and nasal cavity, respectively. In order to prolong contact time, nasal drops are formulated as solutions of increased viscosity. Solid dosage forms include tablets, coated tablets, and capsules (B). Tablets have a disk-like shape, produced by mechanical compression of active substance, filler (e.g., lactose, calcium sulfate), binder, and auxiliary material (excipients).

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  • What is the definition of a formulation? Why is it needed? What is the importance of a formulation? These are some important questions that need to be addressed during the development of a potential drug product. The strict definition of the word is to specify a formula or to express a formula in systematic terms or concepts. The formula, in the current case, is a pharmaceutical dosage form. A formulation is needed to deliver the drug or the active pharmaceutical ingredient (API) to its targeted site. In order to overcome some of the physiochemical limitations of an API,...

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  • This Handbook of Manufacturing Techniques focuses on a new aspect of the drug development challenge: producing and administering the physical drug products that we hope are going to provide valuable new pharmacotherapeutic tools in medicine. These 34 chapters cover the full range of approaches to developing and producing new formulations and new approaches to drug delivery. Also addressed are approaches to the issues of producing and packaging these drug products (that is, formulations).

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  • Pharmaceutical products covered in the Pharmaceutical Zero-for-Zero Initiative can be imported either as bulk active ingredients or in dosage forms that can be packaged for retail sale. Products in dosage form are generally classified under chapter 30 of the HTS, where most of the subheadings are duty-free. Many of the bulk pharmaceutical active ingredients and chemical intermediates are classified under HTS subheadings that also contain non-pharmaceutical products and have rates of duty ranging from 0 to 6.5 percent ad valorem.

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  • Inpatient Therapy Pneumococcal pneumonia is readily treatable with β-lactam antibiotics. The conventional dosages shown in Table 128-5 are acceptable against intermediately resistant strains and against many or most fully resistant isolates. Recommended agents include ceftriaxone and cefotaxime. Ampicillin is also widely used, usually in the form of ampicillin/sulbactam. The likely efficacy of newer quinolones such as moxifloxacin, macrolides such as azithromycin, and clindamycin is discussed above.

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