3/21/2021 0 Comments Usp Organoleptic Test
Compounding provides tailored therapy to patients who may not be able to use commercially available formulations due to dosing requirements, allergies or rare diseases.USP General Chapter provides standards for compounding quality nonsterile preparations.The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing opportunities for public input from stakeholders throughout the standard setting process.Browse and register for courses and webinars offered around the world.
It refers to the set of checks or tests carried out during the manufacturing process and before the final products are released to the market to ensure compliance with specifications. QC measures are undertaken to ensure that the finished chewable tablet fulfils the specifications of quality. Basically, for a finished pharmaceutical product, it should not only be possible to identify and assay the active substance(s), the content of Active Pharmaceutical Ingredient (API) and weightmass of unit dose should be uniform. The finished products should also be stable under the normal storage condition. Therefore, solid chewable tablets should: have uniform weight and content as well as thickness and diameter; release the active substance in a reproducible (and controlled) manner; have sufficient strength to withstand shock, and frictionabrasion during production, handling and transportation; be elegant in appearance; be well packaged. The following important quality control tests are carried out on chewable tablets Contents 1 1. Hardness test 8 8. Organoleptic evaluation 8.1 a. Taste 8.2 b. Mouth-feel 8.3 c. Colour 8.4 d. Odour 9 9. Chewing property 10 10. Content of active ingredient In order to ensure that the preparation actually contains the active ingredient claimed, an identification test, such as infrared (IR) spectrum, ultraviolet (UV) absorption maxima, chromatogram or assay by titration, as specified in the monograph of the drug, should be carried out. For instance, the IR spectrum of a dispersion of the tablet in potassium bromide discs should be concordant with that of the reference standard. Uniformity of content of active ingredients Samples of the product selected at random should be uniform in content of active ingredient to ensure uniformity of dosage. The requirements shown in the table apply when the stated limits are 90 to 110. For limits other than 90 to 110, proportionately smaller or larger allowances should be made. Requirements for adjustments of content of active ingredient of tablets for limits of 90 to 110 BP, 2009 Unless otherwise prescribed or justified and authorized, content of active substance less than 2 mg or less than 2 of the total mass comply with test A for uniformity of content of single-dose preparations. The test A condition is that the tablet preparation complies if each individual content is between the limits of 85.0 and 115.0 of the average content. The preparation has failed if more than one is outside of the limits or if one is outside of the limits of 75.0 to 125.0 of the average content. If the preparation contains more than one active substance, the requirement applies only to those active substances which correspond to the above conditions. Not more than 2 deviate from the average weight and non-twice the limit (10 for tablets weighing 80 mg or less; 7.5 for more than 80 mg and less than 250 mg, and 5 for 250 mg or more). Disintegration time test This test is usually not required for chewable tablets. ![]() The current absence of clear guidance on dissolution rate requirements has led to a situation in which there are no consistent and suitable quality requirements with which the manufacturers of chewable tablets must conform. Regulatory authorities in many countries may be unable to insist on requiring conformity to dissolution rate testing for chewable tablets if international references such as The International Pharmacopoeia do not require it. The world health organization (WHO), (2011) had aligned with the position of the USP that: no product, including suspensions and chewable tablets, should be developed without dissolution or drug release characterization where a solid phase exists. It goes on to outline the development of in vitro test methods and design of in vivo study protocols. Consistent with the USP, the Food and Drug Administration (FDA) Bioavailability and Bioequivalence Studies for Orally Administered Drug Products General Considerations (2003), page I7(8), states: We recommend that rapidly dissolving drug products, such as buccal and sublingual dosage forms (and chewable tablets), be tested for in vitro dissolution and in vivo BA andor BE. We recommend that chewable tablets (as a whole) be subject to in vitro dissolution testing because they might be swallowed by a patient without proper chewing. In general, we recommend that in vitro dissolution test conditions for chewable tablets be the same as for non-chewable tablets of the same active ingredient or moiety A joint position paper (9) by the International Pharmaceutical Federation (FIP) and American Association of Pharmaceutical Scientists (AAPS) reviewed some of the issues concerning dissolution testing of chewable tablets and came up with the statement In principle, the test procedure employed for chewable tablets should be the same as that used for regular tablets. This concept is based on the possibility that a patient might swallow the dosage form without proper chewing, in which case the drug would still need to be released to ensure the desired pharmacological action.
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