Compatibility Analysis

Compatibility Analysis

Generally, a dosage form is composed by the active pharmaceutical ingredients (APIs) and a large number of excipients mainly including filler, wetter, lubricant, and adhesive. Although excipients are usually pharmacologically inert, they may undergo physicochemical reactions with the drug compounds and even other kinds of excipients after being mixed with each other during the formulation development. Besides, the drug-drug compatibility is also should be taken into account due to the increasing number of compound preparations. These interactions may result in significant adverse effects on the final products properties including stability, disintegration, dissolution rate, and the most important bioavailability.

Application of comprehensive compatibility analysis

  • Maximize the stability of the dosage form
  • Avoid the potential quality and safety risk
  • Promote the drug discovery and development
  • Facilitate to select the suitable type of excipients
  • The compatibility analysis data is essential for IND (investigational new drug) submission

Below is a list of our available Compatibility Analysis Services (include but not limited to the following):

Drug-excipient Compatibility Screening

As an essential process during the pre-formulation development, drug-excipient compatibility assay plays a significant role in selecting the most appropriate excipients. Generally, a desirable excipient can exert negligible effects on the physicochemical properties and pharmacodynamics of the active pharmaceutical ingredient. Knowing that the estimation of drug–excipient interactions is of great importance to achieve considerable stability, bioavailability and manufacturability of solid dosage forms, BOC Sciences has developed a miniaturized high throughput drug-excipient compatibility test to meet your needs.

During the development of compound preparations, the issues related to drug-drug interactions are an important aspect that should be effectively addressed. The interactions between different APIs can lead to serious adverse effects on the chemical structure of drug substances and event change or eliminate the pharmacological activity of the final products. We will conduct a series of tests, including structure determination, qualitative detection and ICH stability analysis under the conditions of high temperature, high humidity, and strong light, to complete the drug-drug compatibility screening for your project.

Excipients are universally non-bioactive substances and their initial selection should be based on the appropriate administration methods and characteristics. The mutual influence within excipients is widely researched in the field of pharmaceutical technology to provide certain function and nature of drugs and dosage forms and improve the speed and degree of drug absorption, or to delay or prevent drug absorption rate. The suitable design of excipient and chemical compatibility test provides a systematic and efficient method for the chemical interaction between excipients under the condition of drug existence and accelerated stress.

Why Choose BOC Sciences?

The compatibility analysis provided by BOC Sciences belongs to the part of total strategies of drug development, aiming to predict the long-term stability of a drug product quickly and accurately. Our goal is to avoid expensive material wastage and considerably reduce the time required to arrive at an appropriate formulation. Furthermore, a wide array of techniques and approaches are available to support the compatibility analysis:

  • DSC-Differential Scanning Calorimetry
  • DTA-Differential Thermal Analysis
  • Accelerated Stability Study
  • FT-IR Spectroscopy
  • DRS-Diffuse Reflectance Spectroscopy
  • SIC-Self Interactive Chromatography
  • ITLC-Thin Layer Chromatography
  • HPLC-High Pressure Liquid Chromatography
  • Radiolabelled Techniques
  • Vapour Pressure Osmometry
  • Fluorescence Spectroscopy

Reference

  1. Chadha, R., & Bhandari, S. (2014). Drug–excipient compatibility screening—role of thermoanalytical and spectroscopic techniques. Journal of pharmaceutical and biomedical analysis87, 82-97.
Quote Request
Verification code