This research article gives extensive information about regulatory filing requirements to register oral dosage form (tablets) in European agency. For better and clear understanding this thesis explains registration requirements for Tramadol SR 100 mg Prolonged-Release Tablets in European regulatory Agency. The Common Technical Document (CTD) is an internationally agreed format which contains set of specifications for the application dossier submitted to regulatory authorities in the three ICH regions of Europe, USA and Japan. The structure and format of the CTD was agreed in November 2000 within the International Conference on Harmonisation. It provides guidance for the compilation of dossier for applications for European marketing authorisations and is applicable for all types of procedures i.e., national, centralised including mutual recognition and decentralized procedures and for all types of products and for all types of applications. Applicants should consult with the appropriate regulatory authorities for applicability of this format for a particular type of product. Keywords: CDT, Dossier Preparation, Europe.

In acne treatment, Benzoyl Peroxide is often used. Can be magistral manipulated in gel and cream forms, but his chemical instability makes hard to maintain efficiency and stability of product. The objective of this article is to verify manipulated Benzoyl Peroxide at 2.5% (w/w) stability in gel and cream forms, evaluating formulation in Brazilian National Formulary 2nd Edition by stress test and degradation profile in 0, 7, 30, 60 and 90 days. Was measured Benzoyl Peroxide and Benzoic Acid dosage determination and his kinetics, physical-chemical (pH, viscosity) and organoleptic aspects (color, odor and appearance) in ambient, sunlight, refrigerator and oven conditions. To analyses, it was formulated gel and cream Benzoyl Peroxide at 2.5% (w/w), tested in iodometric and acid-base titration to Benzoyl Peroxide and Benzoic Acid dosage determination, Brookfield viscometer to viscosity, pH meter to pH, and organoleptic evaluation in color, odor and appearance, respectively. Organoleptic and physical-chemical analyses were not statistic significant (p>0.05) but dosages were significant and proved superior stability in cream than gel sample. Are requested further studies to develop more stable formulations for this product. Keywords: Benzoyl Peroxide Gel/Cream, Benzoic Acid, Stress Test, Manipulated Stability Formulations.

Solasodine has diuretic, anticancer, antifungal, cardiotonic, antispermatogenetic, antiandrogenic, immunomodulatory, antipyretic and various effects on central nervous system. The new, simple, reliable, rapid, precise ultraviolet spectrophotometric method has to validate and been developed to analyses Solasolidine in bulk & poly-herbal formulation. Statistical tests are conducted on validation data. It can be concluded that the proposed method is simple, rapid, accurate, precise, economic and reproducible for UV spectro-photometric estimation of solasolidine from pharmaceutical formulation. This method can be successfully applied for routine estimation of solasolidine in bulk and pharmaceutical dosage form.