DISSOLUTION PROCEDURE DEVELOPMENT
The dissolution test should be, ▲in most cases,▲ (USP 1-May-2021)discriminative for the critical quality attributes of the product. ▲The FDA Guidance for Industry Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances (1) discusses the cases in which the dissolution test does not need to be discriminative. The test conditions (media, apparatus, tolerances/acceptance criteria) are typically defined in a case-by-case approach, supported and justified by data obtained with samples from the formulation(s) under evaluation.▲ (USP 1-May-2021)Generally, the compendial apparatus and procedures that can be used are described in 〈711〉, 〈724〉 and 〈2040〉. Any deviations from or modifications to the conditions stated in these chapters are acceptable with appropriate justification. For additional information see also 〈1092〉 and In Vitro and In Vivo Evaluation of Dosage Forms 〈1088〉. Other useful documents are FDA Guidance for Industry Dissolution Testing of Immediate-Release Solid Oral Dosage Forms (2) and FDA Guidance for Industry Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations (3).
The dissolution media to be evaluated should have pH values within the physiological range, e.g. from 1.2–6.8. Dissolution media with pH values outside this range can be used with appropriate justification. The dissolution media for veterinary applications may be animal species specific.
Examples of dissolution tests can be found at the FDA Dissolution Methods database (4) and at the USP Dissolution Methods database (5).
Solid Oral Dosage Forms
The general descriptions of and definitions for solid oral dosage forms can be found in Pharmaceutical Dosage Forms 〈1151〉.
tablets
Effervescent tablets:Effervescent tablets that result in a solution when handled▲ (USP 1-May-2021)according to the instructions to the patient do not require a dissolution test. In this case, a disintegration test is to be conducted.
For effervescent tablets that result in a suspension after being handled▲ (USP 1-May-2021)according to the instructions to the patient, a dissolution test should be developed. Depending on the size of the tablet, it may be necessary to position the paddles of USP Apparatus 2 described in 〈711〉 at a distance higher than 2.5 cm, to avoid having the dosage form being hit by the paddle.
Source from USP and Please refer to USP for details:
desiccant bottle with silica gel
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