Single-Dose Phase I Study To Evaluate the Pharmacokinetics of Posaconazole in New Tablet and Capsule Formulations Relative to Oral Suspension

Challenges and Strategies in Thermal Processing of Amorphous Solid Dispersions: A Review

“…The Meltrex® platform commercialized by Soliqs and AbbVie is perhaps the most well-known example of HME-enabled products in the pharmaceutical industry, including the solid oral dosage forms of Kaletra® and Norvir® for treatment of HIV (34), the recently approved Viekirax® for treatment of HCV (35,36), and other products in development for oncology indications (37). In addition, other pharmaceutical companies have adopted hot-melt extrusion technology with the recent approvals of Onmel® by Merz Pharmaceuticals and Noxafil® by Merck & Co (38)(39)(40). Despite this recent commercial success of HME for pharmaceutical applications, a number of challenges still exist, particularly for thermally labile drugs and polymers, as well as viscosity limitations for a number of pharmaceutical polymer carriers.…”

Posaconazole Tablet Pharmacokinetics: Lack of Effect of Concomitant Medications Altering Gastric pH and Gastric Motility in Healthy Subjects

“…Furthermore, it is believed that the presence of the polymer in the intestinal fluid inhibits the recrystallization of POS, thus ensuring that a greater fraction of the dose is available for absorption. This results in substantially improved exposure (ϳ3-fold) compared with that for the oral suspension in healthy adults in the fasting state (19). This attribute of posaconazole tablets may be beneficial in patients with poor food intake or a limited ability to take the medication with a high-fat meal.…”

Phase 1B Study of the Pharmacokinetics and Safety of Posaconazole Intravenous Solution in Patients at Risk for Invasive Fungal Disease

“…The bioavailability of posaconazole oral suspension is significantly enhanced when given with food (8,9). Therefore, to address this issue, a new tablet formulation of posaconazole has been developed (10). However, a limitation of any oral formulation is that patients at risk for IFD may be unable to take or absorb oral medication (11,12).…”