Influence of Microencapsulation Process Parameters on Naltrexone Prolonged-Release Dosage Form

2014 ◽  
Vol 48 (1) ◽  
pp. 65-68 ◽  
Author(s):  
E. A. Petrova ◽  
S. A. Kedik ◽  
K. V. Alekseev ◽  
E. V. Blynskaya ◽  
A. V. Panov ◽  
...  
Author(s):  
Mandzhigoladze T.Y. ◽  
Kuznetsova L.S.

The purpose of the study was to substantiate the optimal composition, development of technology and methods for analyzing a new dosage form - granules with hydrangeas with a liquid tree extract. Optimal auxiliary substances for granule production were experimentally selected and process parameters were determined: fractional composition, abrasion, disintegration, mass loss during drying, bulk density. It was found that for all indicators granules with hydrangea tree extract liquid meet the requirements of GF XIV. Process diagram of granules manufacturing by wet granulation method has been developed. The TLC method made it possible to identify rutin, quercetin, luteolin, chlorophyll, coumarin. The method of differential spectrophotometry was tested for the method of quantitative determination of the sum of flavonoids. The proposed quantification methodology has been found to be suitable for analytical purposes. The content of the sum of flavonoids in the granules in terms of rutin is about 0,0225%. The relative error of the technique does not exceed ± 2,5%.


Author(s):  
KETAN B. RAMANI ◽  
Vipul Patel

Mebeverine HCl is a BCS class-I drug and thus it possesses high solubility in aqueous media across the biological pH range. The marketed reference product is a multi-unit particulate system (MUPS) containing prolonged release pellets filled in hard gelatin capsule. In conventional manufacturing process, a huge quantity of solvents (aqueous and/or organic) is used to manufacture such dosage form. Additionally, it demands more processing time and efforts. Therefore, a prolonged release capsules dosage form of Mebeverine HCl was formulated using thermoplastic (melt) granulation technique without usage of any solvent. Prolonged release minitablets sized 2 mm in diameter were developed as per quality by design principles. A 23 full-factorial design of experiment was applied to optimize levels of drug release controlling ingredients which includes a hydrophobic meltable binder (hydrogenated castor oil) cum matrixing agent, a hydrophilic meltable binder (polyethylene glycol) which may act as pore former also, and a release controlling polymer (ethyl cellulose). The optimized formulation was found stable. Dissolution profiles of the optimized formulation were found similar to the marketed reference product in different media across the physiological pH range. In conclusion, the explored solvent less process was capable to manufacture the MUPS dosage form of Mebeverine HCl prolonged-release capsules, which is stable and pharmaceutically equivalent with the reference product. The developed process is more beneficial to small and medium scale industry, as it does not require any special and costly equipment, significantly decreases manufacturing cost and increases productivity compared to conventional process, which is mentioned in literature.


2014 ◽  
Vol 919-921 ◽  
pp. 2007-2010
Author(s):  
Jing Min Mao

The mud-containing and fine-grained tailings of limestone and dolomite, as raw material with poly chem soil binder (PCSB), can be used to produce load bearing bricks by means of preparation, measurement, mixing grind, molding, curing and other processes. The molding process parameters were obtained through the soil test of tailings. The curing strength was proved to be greater than C10-15 from the judging test. PCSB was optimized according to the curing and economic cost. The factors such as dosage form, tailings samples, density and water content were discussed in the orthogonal test. The mix of PCSB: tailings: process water =1:9:0.95 in quality was verified in the product test.


2013 ◽  
Vol 20 (1) ◽  
pp. 23-33 ◽  
Author(s):  
Subham Banerjee ◽  
Aashish Tiwari ◽  
Santosh Kumar Yadav ◽  
Shiv Sankar Bhattacharya ◽  
Aher Vaibhav Dagaji ◽  
...  

AbstractXanthan-gum-facilitated aspirin-loaded ethyl cellulose microparticles were prepared by multiple-emulsion solvent evaporation technology and the impact on variation in process parameters was investigated systematically. Scanning electron microscopy was performed to determine the surface morphology of the microparticles before and after dissolution study. X-ray diffraction (XRD), differential scanning calorimetry (DSC), Fourier transform infrared (FTIR) analysis were performed, and yield value, swelling study, encapsulation efficiency, flow properties and dissolution profiles of the prepared formulations were evaluated. The size of microparticles varied between 247 and 410 μm, and 58.34% drug entrapment efficiency was achieved depending on the variation in process parameters. The drug release in acid solutions was slower than in alkaline solution. The microparticles provided extended drug release in alkaline dissolution medium, and the drug release was found to be controlled by Fickian diffusion mechanism. XRD and DSC analyses revealed the amorphous nature of drug in the microparticles. FTIR data indicated the stable character of the encapsulated drug in the microparticles. Thus, variation in process parameters showed a slow and prolonged release of aspirin in simulated intestinal fluid.


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