THE ROLE OF NEEDLE IN FORMULATION OF pH SENSITIVE SWELLABLE MICROBEADS PREPARED WITH HYDROPHILIC POLYMERS FOR ATORVASTATIN AND THEIR CHARACTERIZATION STUDIES

Reddy, K. Venugopal; Nagabhushanam, M.

doi:10.22159/ijap.2017v9i3.16952

Cited by 4 publications

(3 citation statements)

References 12 publications

(12 reference statements)

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“…Formulation simvastatin nanoparticles with single emulsion diffusion method produce 50 % dose reduction without affecting its efficacy [11]. Atorvastatin has low bioavailability (12 %), so it is coated with sodium alginate as a hydrophilic polymer to increase its bioavailability [12]. Other research uses the principle of drug interactions with food/beverage.…”

Section: Introductionmentioning

confidence: 99%

Forced Degradation Study of Statins: A Review

2018

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Forced degradation study is the degradation of new drug substances and drug products in more severe conditions than accelerated conditions. Forced degradation study were conducted to demonstrate the specificity of stability-indicating methods, providing insight into degradation pathways and drug degradation products, assisting in the elucidation of degradation product structures, identifying degradation products that could be spontaneously generated during storage and use of drugs and to facilitate improvement in manufacturing process and formulation corresponding with accelerated stability studies. Statins, a class of lipid-lowering medications, are the most widely prescribed drugs and an example of an unstable drug. Statins are susceptible to hydrolysis in the presence of high temperatures and humidity. Therefore, the review discusses various studies of forced degradation studies in six statins drug (atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin) to describe the drug's intrinsic stability thus it can assist the selection of formulations and packaging as well as proper storage conditions.

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Section: Introductionmentioning

confidence: 99%

Forced Degradation Study of Statins: A Review

2018

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“…It was determined by studying in two different dissolution media naming [10,11]. 0.1 N HCl for the first 2h and later the previous medium was replaced with 6.8 phosphate buffer medium under temperature at 37±0.5°C with 100 rpm and this test will be continued for 8 h with non-stop procedure using dissolution test apparatus USP model and basket (not paddle type) is used to hold microbeads inside which was ready to examine the swelling index.…”

Section: Determination Of Swelling Indexmentioning

confidence: 99%

Fabrication and Evaluation of Oral Controlled Release of Mucoadhesive Alginate Microbeads Containing Fluvastatin Sodium

2019

Asian J Pharm Clin Res

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Objective: The aim of this study is to prepare oral controlled release (CR) of mucoadhesive alginate microbeads encapsulating fluvastatin by gastroretention technology. Methods: The mucoadhesive microbeads containing fluvastatin were produced using emulsification internal gelation technique. The effect of different variables such as sodium alginate concentration and its combination with other hydrophilic polymers, and the effect of various curing agents on particle size, entrapment efficiency, and in vitro studies were evaluated. Results: There was no marked change in drug entrapment efficiency, and dissolution studies occur during the stability studies of fluvastatin. The in vitro results give data that improvement in the CR of the drug from microbeads compared with marketed tablet. Hence, in this regard, to minimize the frequency of drug administration to reduce side effects. The optimum condition for the preparation of stable alginate beads and produce CR manner was occurred at a higher concentration of combined polymer mixture in equal ratios, i.e., 3% w/v. Infrared spectroscopic study (Fourier transform infrared) confirmed the no incompatibility between drug and other excipients. X-ray diffraction study and differential scanning calorimetry were provided evidence that successful entrapment of drug into the alginates microbeads and drug converted into amorphous nature. The efficiency of mucoadhesion strength of microbeads was determined by wash-off study. Conclusion: The kinetic modeling of the release data indicates drug release from the microbeads follow anomalous transport mechanism and super Case-II transport mechanism. Drug release is a function of pH dependent and controlled drug release depends on type and concentration of polymer blend and curing agents. The release kinetics of drug from the alginate beads followed zero order.

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“…Kinetic modeling in vitro dissolution data [26] were analyzed by different kinetic models to find out the n-value, which describes the drug release mechanism. The value of exponent n-value for optimized batch LF8 was found to be the 1.0168.…”

Section: Kinetic Modelingmentioning

confidence: 99%

Study on the Effect of Alginate, Type of Cross Linkers, and Mucoadhesive Polymers on Drug Release From Lovastatin-Loaded Mucoadhesive Cross-Linked Microbeads

K¹,

2019

Asian J Pharm Clin Res

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Objective: The aim of the current study is to prepare and lovastatin-loaded alginate microbeads were prepared using emulsification gelation internal method by the use of different cross-linking agents, polymer effect in different concentrations on drug release and its combination with hydrophilic polymers on drug release. Methods: The effect of sodium alginate concentration and its combination with other hydrophilic polymers on particle size and shape, scanning electron microscopy (SEM) studies, entrapment efficiency, Fourier transform infrared (FTIR) analysis (FTIR), differential scanning calorimetry (DSC) studies, and X-ray diffraction (XRD) studies conducted to determine compatibility of drug and used excipients and in vitro drug release was studied. The efficiency of mucoadhesion strength of microbeads is determined by wash-off study. Results: The optimum condition for preparation alginate beads and produces sustained release manner was occurred at 3% polymer mixture. Infrared spectroscopic study confirmed the presence of compatibility between drug-polymer additives, good drug entrapment, and SEM studies prove microbeads were in spherical and rough particles. XRD and DSC were used to confirm successful entrapment of drugs into the alginates microbeads. The in vitro release profile could be altered notably by changing formulation parameters to give a sustained release of drug from the microbeads. Conclusion: The kinetic modeling of the release data indicate that drug release from the microbeads follow anomalous transport mechanism and super Case-II transport mechanism and drug release is controlled by both swelling and relaxation of the polymer chains. It was found to be drug release is pH dependent. This will help in overcoming the drawbacks of lovastatin with a short half-life, improves the bioavailability. The release kinetics of drug from the alginate beads followed zero order.

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THE ROLE OF NEEDLE IN FORMULATION OF pH SENSITIVE SWELLABLE MICROBEADS PREPARED WITH HYDROPHILIC POLYMERS FOR ATORVASTATIN AND THEIR CHARACTERIZATION STUDIES

Cited by 4 publications

References 12 publications

Forced Degradation Study of Statins: A Review

Forced Degradation Study of Statins: A Review

Fabrication and Evaluation of Oral Controlled Release of Mucoadhesive Alginate Microbeads Containing Fluvastatin Sodium

Study on the Effect of Alginate, Type of Cross Linkers, and Mucoadhesive Polymers on Drug Release From Lovastatin-Loaded Mucoadhesive Cross-Linked Microbeads

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