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Pharmaceutical Process Development

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Journal Scope
Inventi Rapid/Impact: Pharmaceutical Process Development is the peer reviewed journal of Pharmaceutical Sciences. This journal contains the research and review paper related to various process developments vis. manufacturing process, analytical process, purification process etc.



VALIDATION OF STABILITY INDICATING HPLC METHOD FOR THE DETERMINATION OF RELATED SUBSTANCES OF VALSARTAN AND HYDROCHLOROTHIAZIDE IN VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS
Singh D P, Tripathi S P, Singh Narendra, Singh Rajani

A simple, rapid, and precise method is developed and validated on high performance liquid chromatography for the determination of impurities of Valsartan and Hydrochlorothiadizide in combined pharmaceutical dosage form. The chromatographic separation was performed on Inertsil ODS 3V, 5 µm (250 mm x 4.6 mm) using gradient elution of buffer - pH 2.5 (1 mL of triethylamine in 1000 mL of water. Adjust the pH to 2.5 ± 0.05 with orthophosphoric acid) and Acetonitrile. The flow rate was maintained at 1.0 mL min-1 and UV detection was performed at 273 nm. The total run time was 40 min within which the main compound as well as all the known impurities and degradation impurities were separated. Stability indicating capability was established by forced degradation experiments and separation of known degradation products. The method was validated for accuracy, repeatability, reproducibility and robustness. Linearity, limit of detection and limit of quantitation was established for Valsartan as well as for Hydrochlorothiadizide and its known impurities....
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SOLID DISPERSION TECHNOLOGY TO ENHANCE DISSOLUTION RATE OF PIROXICAM USING CROSCARMELLOSE SODIUM AND SODIUM STARCH GLYCOLATE
Shailaja Swamy Matche, M N Nagarsenker

The study was planned to investigate whether the technique of Solid Dispersions would be helpful for enhancing the dissolution of Piroxicam. Solid dispersions of Piroxicam were prepared by solvent evaporation method using carriers such as Sodium Starch Glycolate, Croscarmellose Sodium. Solid dispersions were characterized by differential scanning calorimeter, X-ray diffractometer and evaluated for dissolution profiles of Piroxicam. A marked increase in dissolution rate was observed with all solid dispersions. Among the carriers studied sodium starch glycolate gave the highest improvement in dissolution rate. Selected dispersions were subjected to stability studies....
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ARTIFICIAL NEURAL NETWORK: RECENT OPTIMIZTION TECHNIQUE
Gardharia Darshana R*, Patel Harsha V, Nagar Swati K

A pharmaceutical formulation is composed of system based on a computational techniques, several formulation factors and process variables. Optimization techniques are used in industrial planning, allocation, scheduling, decision-making, etc. An artificial neural network is a computational simulation of a biological neural network. These models mimic the real life behaviour of neurons and the electrical messages they produce between input, processing by the brain and the final output from the brain. There are many types of neural networks designed and new ones are invented but all can be described by the transfer functions of their neurons, by the learning rule, and by the connection formula. ANN structure consists of one input layer, one or more hidden layers and one output layer. This feature of ANN, to extract information from the data presented to them, proves them to be powerful and flexible tools for modelling and predictive purposes and offers great potential for applications in a various field. ANNs are being used in pharmaceutical research to predict the nonlinear relationship between causal factors and response variables. Over past decades ANN have gained more acceptance in pharmaceutical formulation modelling because of some advantages like enhance product quality and performance at low cost and need short time to market and new product development, improve response of product as well as customer and improve confidence. The review enlists various dosage form developed, utilizing ANN and various ANN softwares used for this purpose....
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SUPER CRITICAL FLUID EXTRACTION: AN APPROACH TO GREEN EXTRACTION TECHNOLOGY
Kusum Mori, Shraddha Patel, Pankti Desai, Umang Shah

From the view of environmental apprehension, supercritical fluid extraction technology (SFE) exhibits excellent opportunities to accomplish key objectives in the drug delivery sector. Due to increasingly stringent environmental regulations, SFE has gained wide acceptance in recent years as an alternative to conventional solvent extraction for separation of natural compounds in many analytical, herbal and industrial processes. SFE using carbon dioxide (CO2) has been recognized as a green technology. It is a clean and versatile solvent with gas-like diffusivity and liquid-like density in the supercritical phase, which has provided an excellent alternative to the use of chemical solvents. The efficient extraction can be obtained with shorter extraction time, less amount of sample and can be used for extraction of thermo labile compounds. Sophisticated modern technologies allow precise regulation of changes in temperature and pressure, and thus manipulation of solvating property of the Super Critical Fluids, which helps the extraction of natural products of a wide range of polarities....
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LIQUISOLID COMPACT: A NOVEL TECHNIQUE TO ENHANCE DISSOLUTION RATE OF ANTIHYPERTENSIVE DRUG OLMESARTAN MEDOXOMIL
Swati K Nagar, Darshana Gardharia, Harsha V Patel, Vishnu A Patel

The aim of the work was to improve the dissolution rate of the practically insoluble antihypertensive drug, Olmesartan medoxomil (OLM) by adopting the liquisolid compact (LS) technique. This study was designed to evaluate the effects of different formulation variables, i.e. types of non-volatile liquid vehicles and drug concentrations, on drug dissolution rates. The liquisolid tablets were formulated with liquid vehicles, poly ethylene glycol 400 (PEG400) at five drug concentrations, 10%w/w, 15%w/w, 20%w/w, 25%w/w and 30%w/w. Avicel PH102 was used as a carrier material, Aerosil 200 as a coating material and cross carmellose sodium as a disintegrant. The method as introduced by Spireas and Bolton (1999) was applied strictly to calculate the amounts of coating and carrier materials required to prepare OLM liquisolid tablets. The prepared LS compacts were evaluated for their flow properties such as bulk density, tapped density, angle of repose, carr’s compressibility index and Hausner’s ratio. Quality control tests, i.e. uniformity of tablet weight, uniformity of drug content, tablet hardness, friability test, disintegration and dissolution tests were performed to evaluate each batch of prepared tablets. In vitro drug dissolution profiles of the liquisolid formulations were studied and compared with conventional formulation (olmezest), in simulated intestinal fluid (pH 6.8). The drug release rates of LS compacts were higher as compared to directly compressed tablets, which show significant benefit of LS in increasing wetting properties and surface area of drug available for dissolution. From this study it concludes that the LS technique is a promising alternative for improvement of dissolution property....
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INDUSTRY FEASIBLE APPROACHES TO DEVELOP SUITABLE DISSOLUTION MEDIA FOR ACHIEVING IVIVC OF POORLY WATER SOLUBLE DRUGS
Anishetty R*, Karteek P

Increasing number of poorly water soluble drugs has gained recognition in recent drug development. These drugs lack the ability to go into solution and it is sometimes a more important limitation for its overall rate of absorption than its ability to permeate the intestinal mucosa. Hence it would be extremely useful to have a predictive in vitro dissolution test which correlates with in vivo absorption. Such kind of test could be used when screening new formulations as well as changes in existing formulations with regard to their impact on bioavailability, Pharmaceutical industries and scientists face some challenges to develop such meaningful in vitro dissolution. The present study is an overview on the approaches like simulation of the in vivo gastrointestinal physiology with in vitro dissolution testing methods. These approaches include media composition using bile salts and lipoproteins, changing physicochemical properties which influence drug dissolution, effect of preprandial and postprandial state. Out of the aforementioned strategies use of biorelevant media is the most preferred one. There are many ways to develop the biorelevant media like varying the composition of bile salts and lecithin. Apart from these, surfactant media and novel pH adjusted biphasic media have been discussed. It was found that optimization of biorelevant media is necessary to achieve perfect correlation, but it is unstable and costly. Hence surfactant media and novel pH adjusted biphasic media are better to use out of which biphasic media is cost effective and reduces the money and wastage of time for industries....
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E- ISSN: Awaited


Inventi Rapid
Pharmaceutical Process Development



Frequency: Quarterly
E- ISSN: Awaited


RI Factor- 1.0
Abstracted/ Indexed in: Ulrich’s International Periodical Directory & Google Scholar, SCIRUS, Journal Seek (Genamics), PSOAR, getCITED