Assignment 3
Adult and Pediatric Formulation.
1. Pick a drug that helps you fulfill all requirements.
2. Pick a hypothetical formulation. You have to create an adult and a pediatric formulation
and describe it in detail.
3. For each formulation please describe the following:
a. In a Table the following should be provided:
i. Composition and excipients and the function of each excipient
ii. Assign/create a hypothetical quality standard each the excipients (eg USP,
Ph. Eur. or NF)
b. Storage conditions for the drug product and the shelf-life
c. Manufacturing details on the formulation (please use flow charts here). You do
not need to find the exact manufacturing process. You can propose based on the
readings, lectures, and online supportive articles. For instance the process for
making capsules or tablets is a pretty generic.
4. Develop an alternate route of administration that is different from what you described
above. For instance if you used oral solid dosage for the formulation above then the
hypothetical formulation you develop cannot be delivered orally.
a. Describe this alternate route of administration and the formulation for adults
b. Provide the formulation details requested in point 3 above (you will have to create
realistic composition and excipients appropriate for your alternate formulation)
5. Stick to a 4 page limit and provide all your sources: references and the original articles.
Note: This assignment is not asking for the drug substance details so please do not provide that.
This assignment must be typed and submitted electronically in MS Word (.docx or .pdf) format.
The file must be named in the following format: Lastname_Assignment3. Submit your completed
document to Assignment 3, listed on the Modules and Assignments pages, as a file attachment.
Rubric to be used for grading: Out of 40 points
Criteria
Drug Selection
Adult Formulation
Composition
Adult Formulation
Excipient Information
(Quality Std and
Function)
Adult Formulation
Manufacturing Process
Does not meet
expectations (0)
Does not meet
expectations (0)
Does not meet
expectations (0)
Ratings (points)
Meets some
expectations (2.5)
Meets some
expectations (1.5)
Meets some
expectations (1.5)
Meets all
expectations (5)
Meets all
expectations (3)
Meets all
expectations (3)
Does not meet
expectations (0)
Meets some
expectations (1.5)
Meets all
expectations (3)
Points
5
3
3
3
Adult Formulation
Storage
Pediatric Formulation
Composition
Pediatric Formulation
Excipient Information
(Quality Std and
Function)
Pediatric Formulation
Manufacturing Process
Pediatric Formulation
Storage
Alternate Formulation
Composition
Alternate Formulation
Excipient Information
(Quality Std and
Function)
Alternate Formulation
Manufacturing Process
Alternate Formulation
Storage
Format, layout, and
Language
Does not meet
expectations (0)
Does not meet
expectations (0)
Does not meet
expectations (0)
Meets some
expectations (1.5)
Meets some
expectations (1)
Meets some
expectations (1)
Meets all
expectations (3)
Meets all
expectations (2)
Meets all
expectations (2)
3
Does not meet
expectations (0)
Does not meet
expectations (0)
Does not meet
expectations (0)
Does not meet
expectations (0)
Meets some
expectations (1)
Meets some
expectations (1)
Meets some
expectations (1.5)
Meets some
expectations (1)
Meets all
expectations (2)
Meets all
expectations (2)
Meets all
expectations (3)
Meets all
expectations (2)
2
Does not meet
expectations (0)
Does not meet
expectations (0)
Does not meet
expectations (0)
Meets some
expectations (1.5)
Meets some
expectations (1)
Meets some
expectations (2.5)
Meets all
expectations (3)
Meets all
expectations (2)
Meets all
expectations (5)
3
Late penalty: 10% deduction for each day up to 3 days. After 3 days the grade will be 0.
2
2
2
3
2
2
5
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