Important 4 Difference Between Dissolution and Disintegration test in pharmaceutical

 

    In the pharmaceutical industry, difference between Dissolution and Disintegration is quite difficult to understand for the newbies. These terms are look like as a same but both are having different mechanism to perform as well different purposes also.

         If want to know the difference between dissolution and disintegration then you are at the right place. 


Chapter number <711> is a Dissolution general chapter as per USP and <701> is a general chapter for Disintegration as per USP.


Difference between dissolution and disintegration
Difference between dissolution and disintegration

 

 

What is dissolution in pharmaceuticals?

     Dissolution is a routine test in the pharmaceutical industry. It is one type of in-vitro study of the drug. It is also considered a critical process parameter (CPP) for product filling for approval. Dissolution provides critical information for the prediction of in-vivo drug release profiles.

Dissolution is a time required for drug product to release the active ingredient into liquid dissolution medium under given set of conditions.


     In the dissolution, we can find out the % release of the active ingredient of the drug product. Dissolution is highly influenced by the disintegration rate is drug products.


What is the acceptance criteria for Dissolution as per USP:

    The dissolution test is analyzed in 3 different stages i.e S1, S2, and S3.

In three stages of dissolution total of 24 units are being analyzed.

    In the first stage dissolution (S1) 6 units are analyzed, in the second stage (S2) 6 units are analyzed and the average of 12 units (S1+S2)  are to be reported for final results, and for the third stage (S3)12 units are to be analyzed and the average of 24 units (S1+S2+S3) are to be reported for final results.


    S1 stage results should be Q+5
    S2 stage results should be equal to or more than the Q value and no unit is less than Q-15 
    S3 stage results should be equal to or more than Q value, not more than 2 values less than Q-15 and no unit is less than Q-25.

Importance of dissolution test in pharmaceutical:

   1. Minimizes the use of human volunteers
   2. Ensure batch to batch quality equivalence
   3. It is convenient
   4. Rate-limiting steps
   5. Bioavailability can be corrected with in-vitro dissolution results.
   6. Minimizes the cost and labor.
   7. The Invitro model can be used to screen potential drugs and formulation.



Also Read:


ICH guidelines in short


What is Data Integrity and Alcoa Plus?


What is disintegration in pharmaceuticals?

    Disintegration is a quality parameter for drug products. By performing this test you can fix the concentration of affecting factors such as Binder, Lubricant, and hardness of the drug product.    

     Disintegration time is different for different formulations. It is based on the coating of the drug product. The disintegration test directly impacts the drug dissolution. The more the time required for disintegration more will be the time required to release the drug.


Disintegration is a time required for the drug product to break into small fragments under given set of conditions.



What is the acceptance criteria for Disintegration as per USP:


The disintegration test is analyzed in 2 stages. In the first stage, 6 units are analyzed and all units should be passed. If 1 or 2 fail then the second stage shall be executed. In the second stage 12 units are analyzed and out of 18 units 16 units should be passed and results shall be reported of 18 units.


Importance of Disintegration test (DT) in Pharmaceutical: 

    A disintegration test is important in the pharmaceutical to set the factors affecting the drug product. High variation in the rate of disintegration can lead to uncertainty of the results. Factors affecting such as a binder, lubricant, and hardness can be fixed by analyzing the disintegration test.
 

Factors affecting disintegration time (DT):

Binders, Lubricants, fillers, and Hardness are the factors that affect the disintegration of the drug product. 

 

The major difference between dissolution and disintegration:

Dissolution:


1. It is the time required for releasing the active drug ingredient.

2. Dissolved substances in Different mediums.

3. Applicable for solid, liquid, and gases form of substances


4. Dissolution can happen only after substances with low solubility are broken down.


Dissolution Apparatus

Dissolution Apparatus



Disintegration:


1. It is the time required for the drug to break into small fragments.

2. Applicable on solid substances.

3. Dissolution can be proceeded by breaking substances of low solubility.

Disintegration Apparatus

Disintegration Apparatus




Must read: 

DMF in Pharmaceutical




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