Recent Method Development by Analytical Techniques of New Fda Approved Rugs in 2021

PARMAR, ISHVARCHANDRA; PATEL, YOGI A

doi:10.22159/ijcpr.2022v14i3.1975

Cited by 4 publications

(2 citation statements)

References 18 publications

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“…The animal dose of IBH was estimated with relevance to the human dose by using the formula below. The dosage form was administered through the gastric intubation method [18].…”

Section: Subject Selectionmentioning

confidence: 99%

Design and Development of Pulsin-Cap Chronomodulated Drug Delivery of Selective Anti-Anginal Drug: An in Vitro and in Vivo Evaluation

Parida

Talwar

2023

Int J App Pharm

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Objective: In the current work, an attempt was made to formulate the chrono pharmaceutical drug delivery of Ivabradine HCl to the colon. A time-delayed capsule was prepared by sealing the micro particles inside a gelatin capsule made up of erodible hydrogel plug. Methods: The microparticles were formulated by counter-ion elicited aggregation methodology. A natural polymer such as chitosan was chosen as polycation and smaller molecular electrolytes like sodium citrate, sodium sulphate and sodium tripolyphosphate were chosen as poly-anions. The formulated aggregate microparticles were tested for surface morphology, size distribution, in vitro un-harness and drug excipient interaction. Optimized microparticles formulations were carefully chosen on the basis on dissolution studies. The whole device was enteric coated and hydrogel plug was placed in the capsule opening. Results: The pulsatile capsule was found to be acceptable to delay the drug release in small intestinal fluid and eject out the plugin colonic fluid, thus releasing the microparticles into colonic fluid after a lag time criterion of 5 h. To mimic the pH changes along the GI tract, three dissolution media with pH 1.2, 6.8 and 7.4 were sequentially used. FT-IR study established that there was no interaction between the drug and polymer. Among all the formulations, Ivabradine HCl prepared with sodium tripolyphosphate showed prolonged release for a period of 12 h. Conclusion: The obtained results revealed the system's capability to defer the drug release for a programmable period and prevent a sharp increase in blood pressure during the early morning hours when the risk of heart attack is the greatest.

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“…The animal dose of IBH was estimated with relevance to the human dose by using the formula below. The dosage form was administered through the gastric intubation method [18].…”

Section: Subject Selectionmentioning

confidence: 99%

Design and Development of Pulsin-Cap Chronomodulated Drug Delivery of Selective Anti-Anginal Drug: An in Vitro and in Vivo Evaluation

Parida

Talwar

2023

Int J App Pharm

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“…By understanding the underlying mechanisms of these conditions and developing drugs that target specific pathways, researchers and clinicians can provide more effective and personalized treatment options for patients with rare and complex diseases. There are currently no available methods for the bioanalysis of maralixibat in any type of biological matrix [13]. To address this gap, a recent study has reported the development of a novel bioanalytical method for the quantification of maralixibat in biological samples.…”

Section: Introductionmentioning

confidence: 99%

Bioanalytical Method Development and Validation of Maralixibat in Rat Plasma by Lc-MS/MS Detection and Its Application to a Pharmacokinetic Study

2023

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Objective: To quantify maralixibat in rat plasma utilizing liquid-liquid extraction (LLE) approach, a practical, efficient, and accurate LC-MS/MS approach was devised. Methods: As an internal standard (IS), Elobixibat was adopted. Utilizing an Agilent eclipse C18, 150 mm x 4.6 mm, 3.5 µm column, the drug separation was accomplished using an isocratic mobile phase entailing acetonitrile (ACN) and buffer (1 ml Tri fluoro acetic acid into 1liter water and stir well. Filtered through 0.22µ membrane filter paper) composition of 70:30 (v/v), dispensed at 1.0 ml/min. Results: Multiple reaction monitoring (MRM) positive mode allowed for the simultaneous detection of maralixibat and elobixibat exhibiting proton adducts around m/z 676.0278-290.3625 and m/z 696.8541-480.6328, correspondingly. The correlation coefficient (r2) of the approach was ≥0.99977 across a linearity concentration spanning between 5.00–100.00 ng/ml. This technique achieved intra-day accuracy and precision between 99.31-100.93% and 0.22-6.55%, correspondingly. Across 3 freeze-thaw sessions, bench top testings, and postoperative stability investigations, maralixibat was shown to be stable. Conclusion: Through intravenous injection, this approach was effectively utilized in rats for studying the drug's pharmacokinetics.

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Different Analytical Techniques for the Analysis of Anticancer Drugs-Bosutinib, Encorafenib and Dabrafenib-a Review

JAYAPRAKASH

VENKATESAN

VENGADHAJALAPHATH

et al. 2023

Int J Curr Pharm Sci

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In this present situation there is an increase in the number of diseases has been observed but before this drug come to market, it must undergo several procedures. The validation and analytical methods are the important techniques that help in ensuring its purity and reliability. This process involves the use of various analytical techniques to collect data about the drug. This review includes various types of analytical techniques such as ultraviolet-visible Spectrophotometric and chromatography methods such as high-performance liquid chromatography, hyphenation techniques such as LC-MS for the estimation of selected anti-cancer drugs.

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Recent Method Development by Analytical Techniques of New Fda Approved Rugs in 2021

Cited by 4 publications

References 18 publications

Design and Development of Pulsin-Cap Chronomodulated Drug Delivery of Selective Anti-Anginal Drug: An in Vitro and in Vivo Evaluation

Design and Development of Pulsin-Cap Chronomodulated Drug Delivery of Selective Anti-Anginal Drug: An in Vitro and in Vivo Evaluation

Bioanalytical Method Development and Validation of Maralixibat in Rat Plasma by Lc-MS/MS Detection and Its Application to a Pharmacokinetic Study

Different Analytical Techniques for the Analysis of Anticancer Drugs-Bosutinib, Encorafenib and Dabrafenib-a Review

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