Understanding Dissolution Testing

All forms of drugs have to first dissolve in order to effectively work in the body. If we swallow a capsule it disintegrates within a few minutes as it is then the drug needs to dissolve in the fluids of gastrointestinal traits before getting absorbed into the circulation.

This is why the dissolution rate of the capsule is highly significant. Even a slight difference in its performance can hamper safety and efficacy of the drug formulation to a major extent.

The pharmaceutical products that are not true solutions require dissolution testing as the dissolution rate affects the bioavailability. It is essential to maintain quality control and to monitor the formulation and manufacturing process of dosage form.

Moreover, dissolution tests are prescribed in all applicable pharmacopeial monographs. It is an important aspect in drug development and clinical trials as it monitors the rate of solution and amounts of drugs going into the solution in a defined time period and predetermined conditions. 

It provides information regarding the extent of drug absorption in the body. It can also access the effects of drug substance bio pharmaceutical properties and formulation principal on the release properties of a drug product.

A large proportion of drugs available in the market are poorly water soluble. In this case dissolution testing is crucial for its bioavailability and therapeutic effect. It is necessary to evaluate the performance of a product, safety and efficacy of drug formulation. To cap it all a routine dissolution evaluation test is essential for your pharmaceutical business.

Why dissolution test?

  •         To maintain the quality of a drug product and its performance.  
  •         It is essential in development phase, in vivo performance
  •         Drug commercialization
  •         Post marketing stages of a product.
  •         It is also required for immediate release of IR formulations,  reliable information
  •         To support post approval changes from FDA.
  •         During product development, dissolution tests can be performed in a laboratory for method validation once it is approved for                commercialisation.

Dissolution Test Procedure

Dissolution testing is a significant requirement for all solid dosage forms and it is used in all phases of development for product release and stability testing. It is primarily an analytical test for detecting physical changes in active pharmaceutical ingredients and formulation of products.

  • In the general procedure for dissolution test, a liquid named as dissolution medium is placed in the vessels of a dissolution unit.
  • The dissolution medium should be water or water-based having a pH in the range of 5-7 at 37 ºC.
  • Medium should be used according to the standard test procedure of the product.
  •  The dissolution medium should be degassed through sonication method as the presence of dissolved gases could affect the results. This is why the drug is placed within the medium in the vessels once it has reached sufficient temperature. Further, the dissolution apparatus is operated.
  • HPLC and Ultra violet visible spectroscopy detects the sample solutions.
  • The tested samples must meet the criteria of release specifications. The parameter “Q” denotes the percentage value of quantity of active ingredients dissolved within the monograph of a sample solution.

Dissolution studies

  •  Dissolution testing originated with an idea to test the quality of a solid oral dosage form like a tablet and gradually emerged as an authentic and powerful tool for the credibility of drug product quality and its performance.  Gradually it has become a significant aspect of drug development and quality control which ultimately is an indispensable element in the pharmaceutical industry.
  •  The dissolution testing is important for a commercial pharmaceutical product to ensure consistency between production batches, product stability, quality control and quality assurance, monitor formulation changes, study drug release pattern, and establish in-vivo-in-vitro correlations.
  • In the regulatory sphere, dissolution testing plays a major role in the decision-making process, particularly in the development and approval of generic dosage forms, where needless human clinical studies can be avoided without compromising the quality of generic drug products. The dissolution studies can make the drug product authentic as it leads to approval of the product.
  • In dissolution testing data integrity is pivotal as the appropriate documents are crucial for regulators.  

Dissolution Test in our labs

We provide dissolution testing services to ensure safe, robust and successful pharmaceutical dosage form. Our state-of-the-art laboratory located in New Delhi, Baddi in Himachal Pradesh and Bangalore in Karnataka are fully equipped and routinely carry out drug development, quality control and release testing programs. We support you to meet regulatory standards to fulfill the parameters of quality and safety assurance.  Contact us to get your samples tested.

 

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3. Once you approve the quotation, you can send us the sample for testing and we would provide you with the test report.

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