How to Use Dissolution type-III, Objective and Advantages of Reciprocating Cylinder, What is Dissolution Type-III Apparatus?, Calculation of % Dissolved in Type-III

Type-3 Dissolution Tester Apparatus

 The design of the USP Apparatus III, based on the disintegration tester, additionally incorporates the hydrodynamic features from the rotating bottle method and provides capability agitation and media composition changes during a run as well as full automation of the procedure.

Electrolab Type -III Dissolution apparatus with auto-sampler unit


History:-
The reciprocating cylinder was proposed by Beckett and coworkers. and its incorporation into the USP followed in 1991. The idea to generate a new test method came from a presentation at the International Pharmaceutical Federation (FIP) Conference in 1980 (U.S. Pharmacopoeial Convention).

Objective:-
The main objective of developing and evaluating an IVIVC is to establish the dissolution test as a surrogate for human studies, as stated by the Food and Drug Administration (FDA). Analytical data from drug dissolution testing are sufficient in many cases to establish safety and efficacy of a drug product without in-vivo tests, following minor formulation and manufacturing changes (Qureshi and Shabnam, 2001). Thus, the dissolution testing which is conducted in dissolution apparatus must be able to provide accurate and reproducible results.

Advantages:-
  • Apparatus III can be especially useful in cases where one or more pH/buffer changes are required in the dissolution testing procedure, for example, enteric-coated/sustained release dosage forms,for each time interval. It also avoids cone formation for disintegrating (immediate release) products, which can be encountered with the USP apparatus II. 
  • The advantages of mimicking the changes in physiochemical conditions and extraordinarily strong mechanical forces experienced by the drug products in the mouth or at certain locations in the GI tract, such as the pylorus and the ileocecal valve. 
  • The USP Apparatus III is considered as the first line apparatus in product development of controlled-release preparations, because of its usefulness and convenience in exposing products to mechanical as well as a variety of physicochemical conditions which may influence the release of products in the GI tract. 
  • Hydrodinemics can directlly influnced by varing of dips rate, The hydrodynamic forces in this apparatus were found to be stronger in comparison to Apparatus I and II. The results showed that 5 dpm (dips per min) in apparatus III is equivalent to 50 rpm in Apparatus II. Hence, higher dip rates are creating forces that may not be achieved by the use of the paddle instrument but which are highly desired to mimic human masticator forces.
  • Formulation which need different type of mediums and have lower volume of dissolution medium 
Basic Apparatus used in Dissolution Tester Type -III Apparatus

Dissolution parameters:-
  1.  Dissolution Medium- 200 ml to 250 ml.
  2. DPM- Dips Per Minutes - 5 dpm to 50 dpm.
  3. Time intervals- as pet analytical test procedure.
  4. Drain time- time required to drain the media from cylinder to dissolution vessel.
  5. Hold Dip Time- time required where cylinder is dip in medium to wet the cylinder and sample. 
  6. Temperature:- 37.0°C (range 0.5°C).

How to use :-

  •  Start the apparatus as per the manual insrusted and on the temperature to achieve 37°C.
  • Fill the stated volume of dissolution medium in to the dissolution vessel (previously cleaned and dried).
  • Adjust the sample holding apparatus as per specified in manual.
  • Place the tablet in the dry sample holder .
  • Set the parameter as per specified in your test procedure (DPM, Batch detail , Hold dip time etc..).
  • After attaching the apparatus start the dissolution.
  •  Observation:- Unlike other dissolution apparatus reciprocating cylinder shows upward and downward  strokes of cylinder with distance of 9.9 to 10.1 cm.
  • While your specified interval the sample apparatus hold its position in air at top of the dissolution vessel of the same time point, so the the excess amount of dissolution medium drain. 
  • Sample is to be withdrawal, and remaining volume of the dissolution medium must be measured so that loss of Dissolution medium can be recognized.  

Calculation:-

Calculation in Dissolution Type-III is quiet different with reference to Dissolution Type-I and Type-II
In Type-I & Type-II


% Dissolved =  % Result of final time point + the correction factor of all the time point except final time point

While in Type-III Cumulative of all the % Results of the unit in all the time point

%Dissolved = T1+T2+T3=100%
Where,
T1 is the result of time point  one
T2 is the result of time point two
T3 is the result of time point three
Note : those cumulative should be in the range of your specified limit

Those Information are gathered fro USP Monograph <711>, If you have other information related than post it in comments box which could shear to other for better intelligence 

"Learn and Let Learn"


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