Answered step by step
Verified Expert Solution
Link Copied!

Question

1 Approved Answer

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

image text in transcribed

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

Step by Step Solution

There are 3 Steps involved in it

Step: 1

blur-text-image

Get Instant Access to Expert-Tailored Solutions

See step-by-step solutions with expert insights and AI powered tools for academic success

Step: 2

blur-text-image

Step: 3

blur-text-image

Ace Your Homework with AI

Get the answers you need in no time with our AI-driven, step-by-step assistance

Get Started

Recommended Textbook for

Fundamentals Of Momentum Heat And Mass Transfer

Authors: James Welty, Gregory L. Rorrer, David G. Foster

7th Edition

111972354X, 978-1119723547

More Books

Students also viewed these Chemical Engineering questions