During compatibility study of the AZD7986 project, a peak of 3 area% at the tail (RRT 1.03) of the active pharmaceutical ingredient (API) was discovered for all tablets containing sodium stearyl fumarate (PRUV) under humid condition (e.g. 50 °C/75% RH), regardless of choice of disintegrant or filler combination. The degradant was needed to be identified to understand the corresponding reaction mechanism and help the final formulation design. Structure elucidation was therefore done by...
The objectives of this study were to explore sodium dodecyl sulfate (SDS) and Soluplus on the crystallization inhibition and dissolution of felodipine (FLDP) extrudates by bottom-up and top-down approaches. FLDP extrudates with Soluplus and/or SDS were prepared by hot melt extrusion (HME), and characterized by PLM, DSC and FT-IR. Results indicated that Soluplus inhibited FLDP crystallization and the whole amorphous solid dispersions (ASDs) were binary FLDP-Soluplus (1:3) and ternary...
In the course of application and modernization of buccal dosage forms, lyophilized sponges for transmucosal drug delivery symbolize one of the most attractive approaches. Chitosan (CS) has been extensively investigated as a forming material of different buccal dosage forms including sponges. However, CS-based buccal delivery systems suffer from many limitations like weak adhesion strength and poor tensile properties. So, for the first time, the current study focused on the polymer blending...
This study presents a framework for process and product development on a continuous direct compression manufacturing platform. A challenging sustained release formulation with high content of a poorly flowing low density drug was selected. Two HPMC grades were evaluated as matrix former: standard Methocel CR and directly compressible Methocel DC2. The feeding behavior of each formulation component was investigated by deriving feed factor profiles.
The purpose of present research work was to develop mucoadhesive microparticles of Zaleplon for nasal delivery with the aim to avoid hepatic first-pass metabolism, improve therapeutic efficacy and enhance residence time in the treatment of insomnia.
EMA Publication:
Sodium is an essential nutrient. It is the principal cation in the extracellular fluid (ECF) and has a key role in maintaining fluid balance, acid base balance, muscle and nerve activity and transport of nutrients across cell membranes.
Hydrocortisone sodium succinate (HSS) is an anti-inflammatory drug, but its application on ulcerative colitis (UC) treatment is limited by its associated side-effects. To solve this problem, a kind of pH-sensitive P(LE-IA-MEG) hydrogel microspheres (HMSs) were prepared as the drug carrier of hydrocortisone sodium succinate (HSS) for the treatment of UC. The P(LE-IA-MEG) HMSs were spherical in shape with good dispersion and the mean particle size was 34.87 ± 0.90 µm. HSS was successfully...
The aim of this work was to develop an innovative drug delivery system potentially useful for the local delivery of Bisphosphonates to bone tissue. We propose the use of Solid Lipid Microparticles (MPs), up to now mainly used for oral and topical drug delivery, as carrier for bisphosphonates due to the favourable biocompatibility and lower toxicity of the lipids compared with many polymers. The delivery platform consisted of a biomimetic α-tricalcium phosphate-gelatin cement (CPC) enriched...
Abstract The study discusses the synthesis of polymer-silica composites comprising water soluble drug (ibuprofen sodium, IBS). The polymers selected for this study were poly(TRIM) and poly(HEMA-co-TRIM) produced in the form of permanently porous beads via the suspension-emulsion polymerization method. The acid and base set ternary composites were prepared by the saturation of the solid dispersions of drug (poly(TRIM)-IBS and/or poly(HEMA-co-TRIM)-IBS) with TEOS, and followed by their exposition...