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Dissolution: Lynda Paleshnuik
Dissolution: Lynda Paleshnuik
Lynda Paleshnuik
Training workshop: Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and
assessment of data submitted to regulatory authorities, February 23-27, 2009, Kampala, Uganda.
Overview
Disintegration vs Dissolution
USP <1088>:
and
Starting point:
http://www.who.int/phint/en/p/docf/
https://www.who.int/medicines/publications/pharmacopoei
a/mono_dev/en/index.html
PhInt monographs are available for all APIs and for the
following FPPs:
Single-API FPPs
Artemether capsules
Artemether tablets
Artesunate tablets
Monographs in progress:
Amodiaquine tablets
Sulfadoxine/Pyrimethamine tablets.
Mefloquine tablets
Liquid preparations for oral use under the section, Powders for
oral solutions/suspensions/drops
BP 2008: no monographs.
USP 2009:
Dosage Forms:
Amodiaquine HCl Tablets
Sulfadoxine/Pyrimethamine Tablets
Sulfadoxine/Pyrimethamine Tablets
Medium: pH 6.8 phosphate buffer, prepared as directed under Buffer
Solutions in the section Reagents, Indicators, and Solutions; 1000 mL.
Apparatus 2: 75 rpm.
NLT 60% (Q) each API in 30 minutes.
(The above are in USP 2009 and USP 2009 S1)
pH 6.8 buffer
pH 4.5 buffer
Calculation of similarity:
1) Purpose of study
6) Conclusion/recommendation
a) discriminating, and
Factors to consider:
Manufacturing parameters:
Lubrication
Blend time
Compression force
Drying parameters
Solubility
pH
API quantitation
Solubility:
- Resolution (>2)
Apparatus
Calculations
Acceptance Criteria
Filtration:
Stability of samples:
Check:
4) Published methods
Paddle, 75 rpm
or
DT NMT 10 min
% released: 15 33 49 68 83 98 102
For the 7 APIs in the ACTs, the only hit on the FDA site
is for mefloquine HCl tablets:
Apparatus: Basket
Validation:
Specificity
Linearity
Accuracy
Repeatability
Intermediate precision
Precision:
System precision
Repeatability determination:
OR
OR
Intermediate Precision:
Example 1:
Example 2