3D printed oral solid dosage forms containing hydrochlorothiazide for controlled drug delivery

From ‘fixed dose combinations’ to ‘a dynamic dose combiner’: 3D printed bi-layer antihypertensive tablets

http://s9423e139345e2186.jimcontent.com/download/version/1447395544/module/10157614898/name/1-s2.0-S1818087615000550-main.pdf

Development, characterization and solubility enhancement of comparative dissolution study of second generation of solid dispersions and microspheres for poorly water soluble drug

Hot melt extrusion (HME) is a powerful technology to enhance the solubility and bioavailability of poorly water-soluble drugsby producing amorphous solid dispersions. Although the number of articles and patents about HME increased dramatically in the pasttwenty years, there are very few commercial products by far. The three main obstacles limiting the commercial application of HME aresummarized as thermal degradation of heat-sensitive drugs at high process temperature, recrystallization of amorphous drugs during storageand dissolving process, and difficulty to obtain products with reproducible physicochemical properties. Many efforts have been takenin recent years to understand the basic mechanism underlying these obstacles and then to overcome them. This article reviewed andsummarized the limitations, recent advances, and future prospects of HME.

Application of Hot Melt Extrusion for Poorly Water-Soluble Drugs: Limitations, Advances and Future Prospects

The thermal behavior of some sulfone-containing drugs, namely, dapsone (DDS), dimethylsulfone (MSM), and topiramate (TOP) in drug substances, and products were investigated using different thermal techniques. These include thermogravimetry (TGA), derivative thermogravimetry (DTG), differential thermal analysis (DTA), and differential scanning calorimetry (DSC). The thermogravimetric data allowed the determination of the kinetic parameters: activation energy (E(a)), frequency factor (A), and reaction order (n). The thermal degradation of dapsone and topiramate was followed a first-order kinetic behavior. The calculated data evidenced a zero-order kinetic for dimethylsulfone. The relative thermal stabilities of the studied drugs have been evaluated and follow the order DDS > TOP > MSM. The purity was determined using DSC for the studied compounds, in drug substances and products. The results were in agreement with the recommended pharmacopoeia and manufacturer methods. DSC curves obtained from the tablets suggest compatibility between the drugs, excipients and/or coformulated drugs. The fragmentation pathway of dapsone with mass spectrometry was taken as example, to correlate the thermal decomposition with the resulted MS-EI. The decomposition modes were investigated, and the possible fragmentation pathways were suggested by mass spectrometry.

/pdf/thermoanalytical-investigation-of-some-sulfone-containing-2985zl0qda.pdf

Thermoanalytical investigation of some sulfone-containing drugs.

Hydrochlorothiazide has been studied alone and in combination with excepients which make up a commercial product. This study focuses on the decomposition of hydrochlorothiazide alone. The decomposition reaction of hydrochlorothiazide was studied using a simultaneous TG-DTA unit, in a an inert atmosphere of flowing nitrogen. The compound was subjected to a temperature ramp of 10°C/min from ambient to 600°C. Mass spectrometry was used as a adjunctary technique to identify the products of the decomposition reaction. It was observed that hydrochlorothiazide decomposed via a multistage reaction following melting, with the rate controlling step being a diffusion controlled reaction. The electron spray ionization mass spectrum of the fragmented hydrochlorothiazide shows an abundance of sulphur dioxide, suggesting that this chemical is a major part of the decomposition volatiles lost in the thermal reaction.

A thermal analysis study of the decomposition of hydrochlorothiazide

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A thermal analysis study of the decomposition of hydrochlorothiazide