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"


Comments

Post a Comment

Popular posts from this blog

What is Gestational Diabetes?, Reason and symptoms and treatment of Gestational Diabetes

Image
What is Gestational Diabetes?  Gestational Diabetes only happens during pregnancy. If you have it, you can still have a healthy baby, with help from your doctor and by doing simple things every day to manage your blood sugar. After your baby is born, you may not have diabetes anymore. Gestational diabetes makes you more likely to develop Type II Diabetes, but it won’t definitely happen. Reason:- When you're pregnant, your body naturally becomes more resistant to insulin so that more glucose is available to nourish your baby. For most moms-to-be, this isn't a problem: When your body needs additional insulin to process excess glucose in blood, the pancreas secretes more. But if the pancreas can't keep up with the increased demand for insulin during pregnancy, blood sugar levels rise too high because the cells aren't using the glucose. This results in gestational diabetes. Gestational diabetes needs to be recognized and treated quickly because it can cause h
Read more

Critical information about METFORMIN- An Anti-Diabetic and Different Uses

Image
METFORMIN. Chemical Names: Metformin; 1.1-Dimethylbiguanide Molecular Formula :  C 4 H 11 N 5 Molecular Weight: 129.167 g/mol Mainly medicated for : Type 2 diabetic patients Metformin is an oral diabetes medicine, which can be prescribed together with diet and exercise to improve blood sugar level in adults with type 2 Diabetes Mellitus. It could also used along with Insulin or other medications but under physician or doctors guidance Metformin used for differently other then Diabetes Mellitus Weight loss: It may prompt you to eat less by reducing your appetite and change the way your body uses and stores fat. wight loss occurs in one or two years, which may very person to person in an average 4 to 8 pound in 2 to 4 years. Poly-cystic Ovary Syndrome:  Reproductive-aged women suffer from this syndrome, which is characterized by menstrual irregularities, low fertility, obesity and high blood levels of male hormones. Scientists have discovered that many women with
Read more

SWINE FLU:- How virus works, Prevention, Homeopathic Treatments

Image
“ SWINE FLU ” INDIA IS WITNESSING A SURGE CASES THIS YEAR. WITH THE EPIDEMIC OF SWINE FLU SPREADING AROUND, IT IS IMPERATIVE TO UNDERSTAND THE AILMENT IN ITS PROPER PERSPECTIVE. KNOWING SWINE FLU SYMPTOMS & TAKING TIMELY ACTION CAN LEAD TO MITIGATION OF THE DISEASE TO A GREATER EXTENT. SWINE FLU IS THE POPULAR NAME FOR INFLUENZA CAUSED BY A RELATIVE NEW STRAIN OF INFLUENZA VIRUS A. THE VIRUS CLOSELY RESEMBLED INFLUENZA VIRUS THAT CAUSE ILLNESS IN PIGS. THE VIRUS SPREADS WHEN YOU TOUCH AN INFECTED SURFACE OR BREATHE COUGH AND SNEEZE DROPLETS IN THE AIR. IF YOU ARE INFECTED, YOU CAN BE CONTAGIOUS FOR UP TO 10 DAYS. HOW THE VIRUS WORKS INFLUENZA IS HIGHLY CONTAGIOUS VIRUS AND A PANDEMIC FLU COULD AFFECT UP TO HALF THE POPULATION. CATEGORIES OF SWINE FLU Treatment of Swine Flu:                 In most cases, which are self-limiting, only rest may be helpful. But for cases, which may need aggressive treatment of swine flu, hospitalization is considered. S
Read more