Understanding the properties of the drug substance (also known as the active pharmaceutical ingredient or API) is crucial in developing a successful pharmaceutical formulation. This section focuses on conducting a detailed literature review of the physicochemical properties that are essential to consider during formulation development.
When developing a pharmaceutical product, it’s crucial to thoroughly understand the characteristics of the drug substance, also known as the active pharmaceutical ingredient (API). This understanding helps in designing a stable and effective drug formulation. To begin, a literature review is essential, covering various aspects such as:
- Description: Basic physical and chemical properties of the API.
- Chemical Name: The official chemical name of the substance.
- Molecular Formula and Weight: These tell us the composition and size of the API molecule.
- Water Content: Important for stability and storage, as moisture can affect the API’s properties.
- Solubility: Determines how well the API dissolves in different solvents, affecting bioavailability.
- Melting Point: Gives insight into the purity and stability of the substance.
- Particle Size Distribution: Affects how the drug dissolves, absorbs, and behaves in the body.
- Crystal Properties: Different crystal forms (polymorphs) can impact the drug's solubility and stability.
- pH: The API’s pH behavior in different environments influences how it behaves in the body.
- Dissociation Constant (pKa): This helps us understand how the drug ionizes in various conditions, impacting absorption.
To gather this information, we rely on trusted references like pharmacopeial monographs (USP-NF, IP, BP, EP), and renowned sources such as Martindale, Merck Index, DrugBank and scientific journals.
Read also:
- Literature Review in Pharmaceutical Product Development
- Generic Drug Development Process
- Solubility Database
- Melting Point Database
