Use any resources to search either: (a) one commercial drug product that uses nanocrystal as the formulation technology; or (b) one example of a recent trend in FDA drug approvals.
If you choose option (a), in your original post should include:
• the drug name (both brand name and generic name)
• indication of the drug
• company name
• physiochemical properties of the drug
• method to prepare the nanocrystal of this drug product
• data for dissolution and absorption (either in animals or human) of this drug product
• importantly, a discussion (at least 200 words) on why the nanocrystal was chosen as the formulation technology for this particular drug.
You should include citations to support the data and information you collect for this drug. You can decide the style of citations, but it needs to be consistent through your response. Hint: Dr. Dong provides one case review for lipid-based drug delivery systems and one case review for solid dispersion. You could follow these case reviews to collect the information of the drug you choose.
Finally, respond to at least one other original post with a substantive reply that add additional information or opinions to what has already been posted. You should again provide citations to support your response. Your responses should be thoughtful, meaningful, and respectful.
OR
If you choose option (b), search online databases including the FDA website, FDA or industry press releases, or peer reviewed articles that summarize recent trends in FDA drug approvals through either the NDA or ANDA process. Choose one trend based on a drug product category such as generic vs. brand, type of dosage forms, routes of administration, biologic vs. small molecule, drug-device combination etc, and provide a 300 – 600-word discussion on this topic. Briefly describe the observed trend. What was one potential underlying reason behind this trend? Can you project what this trend might look like in the next ten years?
