I'm working on Azithromycin, solid dosage forms, and I'm trying to find a dissolution test protocol to compare between different companies.
Dear Sir. Concerning your issue about the dissolution protocol for Azithromycin tablet and capsule. The in vitro multi-point dissolution profiles between 3 off-patent products azithromycin dihydrate 500 mg and the innovator product was studied. The paddle-type dissolution apparatus was used. This was rotated at a speed of 50 rpm using 0.1-N HCl as media. Random samples were withdrawn after certain time points and assayed for azithromycin dihydrate. Comparision between test samples and the innovator product was done by computing their similarity (f1) and disimilarity (f2) factors and by fitting them to various kinetics of drug release during dissolution. Test samples 1 and 3 were comparable to the innovator product because they complied with f1 and f2 specifications. Test sample 2, however, gave higher f2 values making it non-equivalent with the innovator product. The Higuchi and Korsmeyer-Peppa kinetics of drug release characterized most of the dissolution profiles. This study showed that test samples 1 and 3 are equivalent with the innovator products in terms of comparative in vitro dissolution profiles where extra-Fickian release behaviors were exhibited by all the preparations I think the following below links may help you in your analysis:
http://www.pfizer.co.jp/pfizer/development/clinical_development/new_medicine_info/documents/apply_document/ciryo/appli_doc_h13_12_zithromac600_ciryo_keii1.pdf
http://www.pharmacopeia.cn/v29240/usp29nf24s0_m6745.html
http://www.japsonline.com/admin/php/uploads/1351_pdf.pdf
https://www.researchgate.net/publication/236461160_Spectrophotometric_Estimation_of_Azithromycin_in_Tablets
Thanks
Dear Samer,
Any reason not to follow the USP40 "Azithromycin Tablets" monograph?
It states for Dissolution the following conditions:
Medium: pH 6.0 phosphate buffer; 900 mL,
Apparatus 2: 75 rpm
Time: 30 min
Regards, LG
Thanks dear Prof. Luis F. Gouveia
Because we don't have USP40 here in Syria, due to sanctions.
Regards
Based on solubility profile sink condition can only be achieved at pH 6.8
So dissolution media pH. 6 or 6.8is recommend
Moreover in tablet dosage form 50 rpm and paddle is preferred
The contribution from Sushani is in line with the USP recommendation, regarding the pH (buffer pH 6.0). However, USP states 75 and 100 rpm for tablets and capsules, respectively. In general, lower stirring speeds are usually preferred to increase the discriminatory ability of the test. In this case, however, higher stirring speed are officially recommended which may indicate insufficient (or erratic) dissolution due to, for instance, coning. Depending on the purpose you may need to demonstrate the discriminating ability of the dissolution method you adopted. Hope it helps.
Completely agree with Gouveia Sir's opinion, that since this is a BCS class II drug and dure to contribution from insoluble ingredients in tablets coning must have been routinely experienced because of which higher rpm has been recommended
Follow USp 36-NF31 for detail. BCS -II drugs need ph range from 6-75 for biowaivers. The dissolution protocols starting from spacified to final results, paddle rpm75, phosphate buffer Ph 6.0, time 30 and hplc condtions
COULD YOU SEND ME USP MONOGRAPH OF AZITHROMYCIN TABLETS? NOW i AM RUNNING TO CONDUCT QUALITY SURVEY ON IT
I have proved that the USP36 Azithromycin tablets procedure, and the monograph system suitability established through Six WS injection
I have proved that the USP36 Azithromycin tablets procedure, and the monograph system suitability proven through Six WS injection
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