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Question II Pantheon Inc., has hired you to formulate a state-of-the- art Oral Liquid suspension of Fexofenadine for one of its customers, marketing pharmaceutical products
Question II Pantheon Inc., has hired you to formulate a "state-of-the- art" Oral Liquid suspension of Fexofenadine for one of its customers, marketing pharmaceutical products for both North America and International markets. Product Attributes: Package Size: 4 fl.ozs (120ml) Drug Dose: Active Fexofenadine (30mg/teaspoonful) Shelf-life: 18 months. Available (micronized drugs) in the R\&D pharmacy. 1. Fexofenadine (mol.wt. =538 ) 2. Fexofenadine Hydrochloride (mol.wt. = 574) 3. Fexofenadine Napsylate (mol.wt. =763 ) 4. Fexofenadine tartarate (mol.wt. =688 ) Others: All required FDA approved pharmaceutical excipients. Questions(s): With reference to this assigned project, answer the following questions: 1. Which one of the available drug forms, you will select in developing your suspension formulation and why? Write the final (percentage w/v ) formulation that you would set up for stability study and all necessary evaluations. Write the functions and rationale for each ingredient in your formulation. List the QA and QC tests that you will perform to assure the quality of this formulation throughout its labeled shelf-life. (Listing only) What will be the anticipated Sedimentation Rate (ml/mon th) of this product, if you were to maintain a final Sedimentation Volume of 0.7 ? Is Stoke's law a suitable tool to estimate the sedimentation rate of drug in this formulation? Please answer Yes/No. with explanation. For initial marketing, write an enlarged (w/v) production type formulation of this product to manufacture 5000(120ml) units
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