Acta Pharmaceutica Sinica B · 2018 · 193 citations · 104 references
PharmacyPharmaceuticsPharmacologyBioavailabilityDrug DeliveryPharmaceutical FormulationCo-delivery SystemsControlled Release MechanismsDrug Delivery BiomaterialsDrug Delivery EngineeringDrug Delivery SystemsSolid Oral Dosage FormsDissolution Media PreparationDrug Co-deliveryPhysical Stability CriteriaPhysical Stability TestingPhysicochemical PropertiesPoorly Soluble Drug FormulationPoorly Water-soluble DrugsTherapeutic Efficacy Assessment
In recent years, the coamorphous drug delivery system has been established as a promising formulation approach for delivering poorly water-soluble drugs. The coamorphous solid is a single-phase system containing an active pharmaceutical ingredient (API) and other low molecular weight molecules that might be pharmacologically relevant APIs or excipients. These formulations exhibit considerable advantages over neat crystalline or amorphous material, including improved physical stability, dissolution profiles, and potentially enhanced therapeutic efficacy. This review provides a comprehensive overview of coamorphous drug delivery systems from the perspectives of preparation, physicochemical characteristics, physical stability, in vitro and in vivo performance. Furthermore, the challenges and strategies in developing robust coamorphous drug products of high quality and performance are briefly discussed.
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