Stability analysis is an area of great interest in preformulation studies. It is a complex set of procedures performed on candidate drug molecules or dosage forms that are in their final immediate packaging intended for marketing, and where appropriate, novel formulation excipients. By investigating the intrinsic stability of candidate drug molecules, useful information which is likely to improve the integrity of the drug products, as well as, prevent alteration in its physical properties, chemical properties and pharmacological effects are obtained.
Preformulation stability analysis includes solid-state stability analysis, solution-state stability analysis and drug-excipients compatibility studies. The key to a good stability analysis is to select concentrations for analysis that allow the detection of degradation product peaks that are at least 0.1% of the parent peak. The stability design and type of testing used will depend on the stage of the development process and the nature of the drug and product under test.
1. Temperature or thermal effect
2. Moisture and relative humidity
3. Light and radiation energy
4. Presence of reacting solvents
5. Order of reaction
7. Chemical nature of the drug or excipient
8. Ionic strength
9. General acid-base catalysis
10. Presence of trace metals, oxygen, and oxidizing agents.
Read Also: Preformulation Studies: Solubility Analysis
Solid-state stability analysis is a very important aspect of drug stability testing. It identifies the stable storage conditions for drug products and also investigates any physical or chemical properties of the drug molecule that may affect the stability of a drug product. This study requires repetitive testing of the initial bulk lot in parallel with newer bulk lots.
Unlike reactions that take place when drugs are in solution, solid-state reactions are usually slower and more difficult to interpret due to a reduced number of molecular contacts between drug molecules and excipient(s) and also the occurrence of multiple phase reactions. Information generated from this analysis is influenced by temperature, pH, humidity, hydrolysis, oxidation, etc.
Solution-state stability analysis provides evidence on unknown liquid incompatibilities that would likely pose a significant challenge during drug development process. It also serves as a guide for formulation processes. During solution-state stability studies, it is important to evaluate
Solution-state stability analysis is capable of identifying loss of API and any consequent increment in degradation products.
This study is carried out to identify all forms of drug-excipient interactions which could alter the stability of a dosage form. In pharmaceutical formulations, drug substances come in direct contact with one or more excipients and therefore, can undergo chemical reactions and physical interactions under favourable conditions producing less active or inactive and toxic by-products with adverse reactions.
Compatibility study is an important process in drug product development as the information generated is very useful to the formulator in selecting appropriate excipients for a drug product. Some of the most frequently used analytical techniques include but are not limited to thermal methods of analysis (e.g., Differential Scanning Calorimetry, Differential Thermal Analysis, Isothermal Titration Calorimetry etc.), spectroscopic methods of analysis (e.g., FT-IR Spectroscopy, X-ray diffraction etc.), Chromatographic methods of analysis (e.g., Thin Layer Chromatography, High-performance liquid chromatography, etc.) and accelerated Stability Study.
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