This paper proposes the use of a pediatric quality target product profile (pQTPP) as an efficient tool to facilitate early planning and decision making during the children-centric formulation design for new chemical entities, or to repurpose/reformulate off-patent drugs.
Current drug discovery and computational modeling efforts are focused on identifying molecules with the physicochemical properties needed to target complex disease states. While this is key to uncovering new chemical entities (NCEs) for transformative therapies, it can impact other properties integral to the bioavailability of a drug.
There are several technologies available for microencapsulating drugs. Finding a CDMO that possesses the experience and expertise necessary to optimize a drug’s efficacy and manufacturing during formulation is integral to a product’s ultimate clinical and commercial success.
An R&D project has shown that the solubility and dissolution characteristics for Itraconazole can be improved by helping them to maintain an amorphous state after spray drying with selected hydrophillic polymers. This technique can be a useful tool for solubility enhancement when dealing with drugs with low solubility in BCS Class II and IV.
One in 17 people will develop dysphagia, or difficulty or discomfort in swallowing, in their lifetime. Even for those with a healthy swallowing function, it can be a challenge to swallow solid oral medications.
Quetiapine is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and depression and is currently marketed as a QD tablet. The study uses technology to fabricate monodisperse quetiapine microparticles to investigate the effects of formulation and size on the release profile of the API.