Kourtney Jefferies PMCY 4510
Take Home Final Exam May 1, 2018
1. As a project leader in pharmaceutical company you are developing a project plan for a New Drug Application (NDA) or ANDA . (3 points each TOTAL 25 points)
a. Select an approved drug or dosage form and develop a Target Product Profile (TPP).
Acetaminophen- Regular Strength Tablet TARGET PRODUCT PROFILE (TPP) Criteria Product Characteristics Target Attribute Therapeutic Indication Temporarily relieves minor aches and pains N/A Patient Population Adults and children over 12 years old Used to help many types of consumers Markets Global Meet global regulatory requirements Route of Administration Oral Patient compliance Dosage…show more content… From the article used to research the polymorphic forms of acetaminophen, DSC and Raman Spectroscopy techniques were used. A single Raman spectrum can identify a polymorph, while DSC uses a temperature scan to observe the relationship between forms that are not all stable at various temperatures. The article shows that 3 different polymorphic crystalline forms of acetaminophen are present. Melting Point 169 °C (336 °F) Solubility (in water) 7.21 g/kg (0 °C) pKA 9.38 c. Discuss your rationale for selecting the dosage form- tablet or capsule.
An estimated 50 million Americans have a need for pain medication each week. Acetaminophen is used to treat conditions such as pain, fever and aches and pains associated with cold and flu symptoms. With millions of anticipated consumptions each week, creating and examining the use of the regular strength tablet of tylenol and variables associated with it regularly can help ensure the best quality of the product. The 325 mg regular dose tablet was chosen because for adults be it is the lowest dose available that will cause the least amount of side effects if consumed properly to improve consumer safety. Oral tablets are also a great dosage form due to high patient…show more content… What type of drug-excipient compatibility studies will you perform and why?
Thermogravimetry (TGA) and differential scanning calorimetry (DSC) will be used to assess the compatibility between acetaminophen and the excipients. DSC is used to show how compatible acetaminophen and each excipient are once combined at various temperatures. DSC will also show if new polymorphic forms will be present once drug
and excipients are combined. TGA is able to show if various forms of degradation will take place when drug and excipients. This can be found by changes in combined mass versus temperature or time.
f. Describe your manufacturing process flow chart with major processing
