Quality control test of marketed tablets and capsules: Industrial Pharmacy
BP506P Industrial Pharmacy I Practical
Aim: Quality control test of marketed tablets and capsules as per I.P.
Theory: Quality control is a procedure or set of procedures intended to ensure that a manufactured product or performed service adhere to a defined set of quality criteria or meets the requirement of the client or costumer. Quality is not an accident this is the result of intelligent effort. The quality in the pharmaceutical industry has become a very important and sensitive issue. In the pharmaceutical industry, it is essential for controlling the errors during the every stage in production process since total quality of the product must be ensured according to compendia of drugs. In order to determine the specifications of the finished product, the quality characteristics related to the manufacturing process should be taken into account. An appropriate specification for each aspect of quality studied during the phase of development and during the validation of the manufacturing process should be determined. At least those aspects considered to be critical should be the object of specifications routinely verified.
Apparatus: Volumetric flask, Mortar and pestle, Pipette, Beaker, Stop watch, Measuring cylinder, Whatman filter paper, uv spectrophotometer, Dissolution apparatus.
Content of active ingredients (Tablets/Capsules): For this test according to IP determine the amount of active ingredient(s) by the method described in the assay and calculate the amount of active ingredient(s) per tablet/ capsule. The result lies within the range for the content of active ingredient(s) stated in the monograph. This range is based on the requirement that 20 tablets/ capsules, or such other number as may be indicated in the monograph, are used in the assay. Where 20 tablets/ capsules cannot be obtained, a smaller number, which must not be less than 5, may be used, but to allow for sampling errors the tolerances are widened in accordance with Table 1. As specified by the IP requirements Table 1 apply when the stated limits are between 90 and 110 percent. For limits other than 90 to 110 percent, proportionately smaller or larger allowances should be made
Uniformity of content for tablets:
The content uniformity test is to ensure that every dosage form contains equal amount of drug substance i.e. active pharmaceutical ingredient within a batch. Mainly it is used for testing the consistency of bulk powders before or after compression, liquid orals before filling, also during filling of powders into capsules or liquids into vials or ampoules and amount of active pharmaceutical ingredient within individual units of tablets or capsules.
Normally testing is confirmed by performing specific assay to determine the content of drug material contained in particular dosage form. The content uniformity test is used to ensure that every tablet contains the amount of drug substance intended with little variation among tablets within a batch. Due to increase awareness of physiological availability, the content uniformity test has been included in the monographs of all coated and uncoated tablets and al capsules intended for oral administration.
Randomly select 30 tablets. 10 of these assayed individually. The Tablet pass the test if 9 of the 10 tablets must contain not less than 85% and not more than 115% of the labeled drug content and the 10th tablet may not contain less than 75% and more than 125% of the labeled content. If these conditions are not met, remaining 20 tablets assayed individually and none may fall outside of the 85 to 115% range.
Uniformity of content for capsules:
This test is applicable to capsules that contain less than 10 mg or less than 10 per cent w/w of active ingredient. For capsules containing more than one active ingredient carry out the test for each active ingredient that corresponds to the afore-mentioned conditions. The test should be carried out only after the content of active ingredient(s) in a pooled sample of the capsules has been shown to be within accepted limits of the stated content.
Determine the content of active ingredient in each of 10 capsules taken at random using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precision. The capsules comply with the test if not more than one of the individual values thus obtained is outside the limits 85 to 115per cent of the average value and none is outside the limits 75 to 125per cent. if maximum of three individual values are outside the limits 85 to 115 per cent of the average value repeat the determination using another 20 capsules. The capsules comply with the test if in the total sample of 30 capsules not more than three individual values are outside the limits 85 to 115 per cent and none is outside the limits 75 to 125per cent of the average value.
Dissolution Test:
Dissolution is the process by which a solid solute enters a solution. Dissolution is pharmaceutically defined as the rate of mass transfer from a drug substance into the
dissolution medium or solvent under standardized conditions of liquid/solid interface, temperature and solvent composition. Dissolution is considered one of the most important quality control tests performed on pharmaceutical dosage forms and is now developing into a tool for predicting bioavailability, and in some cases, replacing clinical studies to determine bioequivalence. Two types of apparatus are generally used to carry out dissolution. Usually apparatus Type I (Paddle type) is employed in the evaluation of tablets (or capsule) containing poorly water soluble drugs while apparatus Type II (basket type) is used for partially water soluble drugs. This test is designed to determine compliance with the dissolution requirements for solid dosage administered orally. The test is intended for a
:apside or tablet. This test is provided to determine compliance with the dissolution equirements for solid dosage forms administered orally.
Dissolution Medium: Use the dissolution medium specified in the individual monograph. if the medium is a buffered solution, adjust the solution so that its pH is within 0.05 units of the pH specified in the monograph.
Method: Place the stated volume of the dissolution medium, free from dissolved air, into the vessel of the apparatus. Assemble the apparatus and warm the dissolution medium to 36.5° to 37.5°. Unless otherwise stated, place one dosage unit simultaneously and in a reproducible way in the apparatus, taking care to exclude air bubbles from the surface of the dosage unit. When Apparatus 1 is used, allow the tablet or capsule to sink to the bottom of the vessel prior to the rotation of the paddle.
A suitable device such as a sinker made up of stainless steel may be used to keep the dosage unit horizontal at the bottom of the vessel for tablets or capsules that would otherwise float. When Apparatus II is used, place the tablet or capsule in a dry basket at the beginning of each test. Lower the basket into position before rotation.
Operate the apparatus immediately at the speed of rotation specified in the individual monograph. Within the time interval specified, or at each of the times stated, withdraw a specimen from a zone midway between the surface of the dissolution medium and the top of the rotating blade or basket, not less than 10 mm from the waft of the vessel. Specimen withdrawal at each sampling time point should be from the same location either manually or automatically.
Measure media temperature at each sampling time point, the inter-vessel temperature should agree within a range of 0.4°C. Except in the case of single sampling, add a volume of dissolution medium equal to the volume of the samples withdrawn. Filter the sample solution promptly through a membrane filter disc with an average pore diameter not greater than LORI. Discard the first few ml of the filtrate.
Perform the analysis as directed In the individual monograph Repeat the whole operation five times. Where two or more tablets or capsules are directed to be placed together in the apparatus, carry out six replicate tests. The results are plotted as concentration versus time.
OBSERVATIONS:
Content of active ingredients of tablets
| Tablet no | Drug content in each tablet (T1) | Average drug content (T2) | Difference in drug content (T1-T2) | % Difference | More than less than official limit |
Uniformityof drug content
| Tablet no | Drug content in each tablet (T1) | Average drug content (T2) | Difference in drug content (T1-T2) | % Difference | More than less than official limit |
Dissolution test
| Test tube | Time(min) | Filtrate(ml) | Dilution fluid(ml) | Absorbance |
Results:
I. Tablet compliance on the specification of I.P. for content of active= Passes/Fails
II.Tablets compliance on the specification of I.P. for uniformity of content Passes/Fails
III. The percentage of drug present in tablet dissolved in 30 min = =
IV. Capsule compliance on the specification of I.P. for content of active =Passes/Fails
V. Capsules compliance on the specification of I.P. for uniformity of content = Passes/Fails
VI. The percentage of drug present in capsule dissolved in 30 min= ——–%
Industrial Pharmacy I Practical
- Preformulation studies on paracetamol/aspirin/or any other drug
- Preparation and evaluation of Paracetamol tablets
- Preparation and evaluation of Aspirin tablets
- Coating of tablets- film coating of tables/granules
- Preparation and evaluation of Tetracycline capsules
- Preparation of Calcium Gluconate injection
- Preparation of Ascorbic Acid injection
- Quality control test of (as per IP) marketed tablets and capsules
- Preparation of Eye drops/ and Eye ointments
- Preparation of Creams (cold / vanishing cream)
- Evaluation of Glass containers (as per IP)
Third Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise
Suggested Readings:
Recommended readings:
