Drug-Excipient Compatibility Study

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Drug-Excipient Compatibility Study

Drug-Excipient Compatibility Study

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What is drug-excipient compatibility?

Drug-excipient compatibility study is very much important stage of formulation development of drug product in combination of excipients. It’s significant phase of pre-formulation study. Drug product not only contains active pharmaceutical ingredient (API) but it’s combination of different forms of excipients. it’s important to study the physical and chemical interaction between API and excipient. Generally, for excipient compatibility study combination of binary mix in ratio of 1:1 is assessed. In some instances, to check the extreme interaction and complications, multiple excipient mixture in presence of API were appraised.

Importance of excipients and it’s compatibility with API:

Selection of appropriate excipients could be done by performing the drug excipient compatibility study. It supports to prevent the expected last-minute complications throughout the process of formulation development.

Role of excipients is important in formulations development of active ingredient into effective drug product. Excipients enhance the essential quality of the drug product such as exact required dosage, stability, solubility, performance, acceptability, quality, absorption of the drug in vivo, safety and efficacy. As per regulatory requirements drug-excipient compatibility study require to predict probable degradation pathways of the drug product. This study supports to recognize the selection of appropriate excipients and helps to understand the interaction between drug and excipients and the storage condition of the product.

Interaction of drug-excipients:

Drug-excipient compatibility complications obtain from the direct reactions amongst API and excipients or by the presence of responsible impurities in the excipients. Interaction between excipient and the presence of sensitive functional group of API results into incompatibility of drug-excipients compatibility study. Degradation of drug in presence of excipients lead to formation of impurities and to identify these impurities need complete understanding of the reaction and sufficient analytical details. Analytical characterisation data helps to understand the possible degradation pathway of API.  

Following are the some of the typical process of drug-excipient compatibility which may impact the drug product stability in presence of excipient.

  1. Physical interactions,
  2. Chemical interactions,
  3. Physiological interactions,

Analytical techniques for the analysis of drug-excipient compatibility samples:

Following are the details of analytical technique used for the analysis of drug excipient compatibility samples:

  1. HPLC-High Pressure Liquid Chromatography,
  2. Differential Scanning Calorimetry.
  3. Fourier-transform infrared spectroscopy,
  4. X-ray powder diffraction instrument,
  5. Thin Layer Chromatography,
  6. Osmometry,
  7. Vapor Sorption Analysis,
  8. LC mass spectrophotometer,
  9. Nuclear magnetic resonance etc.

Conclusion:

Drug-excipient compatibility is a key stage for the development of well planned, robust, safe, stable and bio-available drug product. It helps to understand the selections of suitable excipients, appropriate formulation composition, proper primary packaging material and suitable storage condition of drug product. Selection of appropriate excipients and evaluation of probable unsuitable excipient during the pre-formulation studies is mainly to achieve the target product profile (TPP) and critical quality attributes (CQA).  

References:

  1. ICH Q1A (R2) (2000) Stability Testing of New Drug Substances and Products,
  2. ICH Guideline Q3A (R) (2002) Impurities in New Drug Substances,
  3. Baertschi, S.W., Alsante, K.M. and Reed, R.A. (2011) Pharmaceutical Stress Testing: Predicting Drug Degradation.2nd Edition, Informa Health Care,
  4. Chaurasia G. (2016). A Review on Pharmaceutical Preformulation Studies in Formulation and Development of New Drug Molecules. International Journal of Pharmaceutical Science and research,
  5. Crowley and Martini, P. Crowley, L.G. Martini Drug-excipient interactions, Pharmacy Technology.

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