The official dissolution apparatus has its inherent advantages and disadvantages and is therefore ideal for dissolution testing of various pharmaceutical studies.
Dissolution testing of solid dosage forms has been well-known as a standard (official test by pharmacopeias) method for evaluating drug release from tablets as well as capsules. Presently, this is the most useful in vitro technique to verify batch uniformity and is an important quality control process for evaluating the release profiles of various finished product batches.
There are different types of dissolution apparatus are used in different studies, it ranges from apparatus I to VII according to USP, BP, and IP. Generally, they consist of vessels, paddles, basket, pump, water tank, rotating motor, and temperature controller, etc.
Advantages of dissolution testing:
- The major advantage of dissolution testing is that the rate of release and the extent of absorption of a drug is determined by the dissolution of the dosage form.
- The dissolution test apparatus is robust and simple to use, requiring no specialist to handle.
- It is well standardized and sufficiently flexible to allow perform testing for a broad range of oral solid dosage forms.
- Dissolution testing is used to determine the quality of pharmaceutical products (tablets/capsules) based on the characteristics of in vitro release of the products.
- Dissolution testing is used to establish the quality of pharmaceutical products, mostly tablets and capsules, based on the in vitro drug release characteristics of these products.
- Dissolution testing of solid dosage forms plays a significant role in the decision-making process from a regulatory perspective, mainly in the development and approval of generic medicines, where it is possible to avoid unnecessary human studies without compromising the quality of pharmaceutical products.
- The pharmaceutical manufacturer takes advantage of dissolution testing by using it to assess product development, product stability, quality control, and quality assurance, and to establish in-vitro-in-vivo correlation.
- The dissolution apparatus can be easily automated which is important for routine investigations.
Disadvantages of dissolution testing:
- The major disadvantage of the dissolution process is that the amount of media required to be maintained at each interval time, which feels the analyst uncomfortable.
- The results depend on other instruments, the sample of dissolution needs to be analyzed in UV/VIS spectrophotometer or high-performance liquid chromatography (HPLC).
- Dissolution requires large amounts of media and takes longer to prepare and adjust the pH of the buffer.
- Liquid dosage forms are not tested using this process; it is suitable only for solid dosage forms.
- Between the processes, it is often difficult to change the pH/media.
- Each drug and product has different properties, so in some cases, there is a problem of sticking and floating.
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