A pharmaceutical company is developing an oral product conta…
A pharmaceutical company is developing an oral product containing a highly water-soluble drug substance. During development, the following products are considered: Product A: An immediate-release conventional tablet for direct oral administration. Multiple development batches consistently demonstrate rapid drug release. Product B: An effervescent tablet that is dissolved in water before administration. The drug substance is highly water soluble. Product C: An immediate-release conventional tablet containing the same highly water-soluble drug substance, but only limited development data are available regarding the consistency of its drug-release characteristics. Product D: An immediate-release conventional tablet containing a poorly water-soluble drug substance, although development studies demonstrate rapid drug release. According to ICH Q6A, for which product could dissolution testing potentially be replaced by disintegration testing based on the information provided?
Read DetailsTwo tablet formulation series are being assessed:Product X:…
Two tablet formulation series are being assessed:Product X: The API and IPIs are not exactly proportional between strengths, but the ratios of the IPIs to total dosage-form mass fall within the limits in Table 3 of the SAHPRA Variations guideline. Product Y: The API concentration is less than 5 %, the different strengths have similar mass, and differences in API content are compensated by changes in one or more IPIs, with the total mass remaining within 10 % of the bioequivalence-study strength. Which statement is correct?
Read Details