improvingaccesstoappropriatepaediatricart-資料下載頁
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【導(dǎo)讀】JánosPogány,pharmacist,.,Abacavir. Didanosine. Lamivudine. Stavudine. Tenofovir. Zidovudine. Efavirenz. Nevirapine. Indinavir. Saquinavir. Ritonavir. Lamivudine+Stavudine. Lamivudine+Stavudine+Efavirenz. Lamivudine+Stavudine+Nevirapine. Lamivudine+Zidovudine. Lamivudine+Zidovudine+Efavirenz. Lamivudine+Zidovudine+Nevirapine. Eachgastro-resistantcapsule,hardcontains125mg,200mg,250mg. andtitaniumdioxide(E171).2years. Donotstoreabove25°C.3years.openingthebottle.Sucrose20%(3g/15ml). Methylparah
【正文】 size, etc.) of the APIs that can influence the performance of the FPP should be optimized and supported by experimental data. ? The patibility of APIs with each other should be studied and the results documented. ? The patibility of the APIs with excipients should be documented. Dr. Pog225。ny WHO, Geneva 28/34 ILLUSTRATIVE R+D ISSUES A discriminating dissolution method should be developed for the final position of the FPP. Limits should be set for each API in fixeddose FPPs. The dissolution method should be incorporated into the stability and quality control programmes. Multipoint dissolution profiles of both the test and the reference FPPs should be pared. Dr. Pog225。ny WHO, Geneva 29/34 HYPOTHETICAL DISSOLUTION PROFILE OF A 2FDC FPP 0204060801001200 15 30 45 60m i n u t e s% dissolved S e r ie s 1S e r ie s 2S e r ie s 3S e r ie s 4EXISTING FDCFPPs Bracketing and Matrixing Multiple strengths of identical or closely related formulations Dr. Pog225。ny WHO, Geneva 31/34 BRACKETING Examples include but are not limited to 1. tablets of different strengths manufactured by pressing varying amounts of the same granulation, and 2. oral solutions/suspensions of different strengths with formulations that differ only in minor excipients (., colourants, flavourings). Dr. Pog225。ny WHO, Geneva 32/34 MATRIXING Examples include but are not limited to 1. tablets of different strengths manufactured by pressing varying amounts of the same granulation, and 2. oral solutions/suspensions of different strengths with formulations that differ only in minor excipients (., colourants or flavourings). Dr. Pog225。ny WHO, Geneva 33/34 SmPC and PIL ? The results from pharmacokiic investigations must be described briefly in the SmPC of the FPP. ? The SmPC and package insert should be specific with regard to the HIVinfections which can be reasonably treated with the FPP. Dr. Pog225。ny WHO, Geneva 34/34 CONCLUSIONS ? Safe and effective paediatric doses for FDCFPPs, SmPCs and PILs should e from (literature survey of) clinical studies. ? Filmcoated tablets and oral solutions or suspensions can be developed in about 18 months, if preformulation is started soon. ? Development can be accelerated if paediatric FDCFPPs have the same ratio of APIs and positions are essentially similar to those already registered in the ICH region or prequalified by WHO.
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