The literature review is an important part of pharmaceutical product development demonstrating literature based knowledge and understanding of the target drug product. The objective of this study is to find out the development and manufacturing feasibility of the product.
A list of information to be collected during literature review are mentioned below:
RLD/ RS/ Reference Product Information
- Active ingredient
- Brand Name
- Strength
- RLD or RS
- Manufacture or Applicant Holder Full Name
- Marketing Status
- Patent Expiry
- Packaging
- Storage condition
- Shelf life
- List of inactive ingredients
- Appearance, Size & Shape
API’s Information
- API’s name
- CAS No.
- Appearance, Molecular weight, Chemical name, and Empirical formula
- Polymorphism
- Solubility
- Partition co-efficient (logP)
- Ph
- pKa value
- BCS Class
- Melting Point
- Boiling Point
- Storage condition
- Precautions (MSDS)
Clinical Information
- Recommended dose
- Maximum daily dose
- Over dose and Side effects
Compendial Information
- Pharmacopoeial status – BP/USP/EP
- Assay limit
- Dissolution media
- Dissolution specification
Analytical Information
- Information about analyte and its known impurities
- Information about analytical method
- Information about analytical techniques
The advantages of this study to find out the associated weaknesses, limitations, problems and chance of failures through the development phase. In the end, the review also enhances the understanding of involving users in the development process.
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