Informatics Publishing Limited

Akhilesh Gupta ¹, Vimal Yadav ¹, Jaydeep S. Yadav ¹, Swati Rawat ²

Affiliations
1 Kunwar Haribansh Singh College of Pharmacy, Jaunpur (U.P.), IN
2 Shri Bhagwan College of Pharmacy, Aurangabad (M.S.), IN

Abstract

Doxofylline is chemically designated as 7-(1, 3 dioxolone-2-yl methyl) theophylline. Presence of a dioxolane group in position C-7 differentiates it from theophylline. It is a new antibronchospastic drug recently introduced in therapy with pharmacological properties like theophylline; a potent adenosine receptor antagonist. doxofylline do not affect gastric acid secretion; either invivo or in-vitro; unlike theophylline. The lack of side effects with doxofylline indicates that the drug can be used safely and effectively. Some analytical methods for quantitative determination of doxofylline in pharmaceutical formulations like UV-Spectrophotometry, HPLC and LC-MS are reported. The present review deals with the various analytical methods reported as well as adopted for the estimation of doxofylline.

Keywords

Doxofylline, UV, HPLC, LC-MS.

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Akhilesh Gupta ¹, Swati Rawat ², Arun Pandey ³

Affiliations
1 Kunwar Haribansh Singh College of Pharmacy, Jaunpur (U.P.), IN
2 Shri Bhagwan College of Pharmacy, Aurangabad (M.S.), IN
3 Alkem Laboratories, Mumbai, IN

Abstract

A simple, rapid and accurate RP-HPLC method was developed for the determination of doxofylline and photolytic degradation product. The method showed a linear response for concentrations in the range of 1-200 g/ml using acetonitrile: formic acid (90: 10); pH-3.0 as the mobile phase with detection at 274 nm and a flow rate of 1 ml/min and retention time 2.9 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, forced degradation, solution stability and selectivity. Quantitative and recovery studies of the dosage form were also carried out and analyzed; the % RSD from recovery studies was found to be less than 1. Due to simplicity, rapidity and accuracy of the method, we believe that the method will be useful for routine quality control analysis. The acid degradation product as well as pathway was characterized by LC-MS/MS.

Keywords

Doxofylline, RP-HPLC, LC-MS/MS, Degradation Studies.

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Akhilesh Gupta ¹, Swati Rawat ², Mayuri Gandhi ³, Jaydeep Singh Yadav ¹

Affiliations
1 Kunwar Haribansh Singh College of Pharmacy, Jaunpur (U.P.), IN
2 Shri Bhagwan College of Pharmacy, Aurangabad (M.S.), IN
3 IIT, Mumbai (M.S.), IN

Abstract

A simple, rapid and accurate RP-HPLC method was developed for the determination of doxofylline and acid degradation product. The method showed a linear response for concentrations in the range of 1-200 μg/ml using acetonitrile: formic Acid (90: 10); pH-3.0 as the mobile phase with detection at 274 nm and a flow rate of 1 ml/min and retention time 2.9 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, forced degradation, solution stability and selectivity. Quantitative and recovery studies of the dosage form were also carried out and analyzed; the % RSD from recovery studies was found to be less than 1. Due to simplicity, rapidity and accuracy of the method, we believe that the method will be useful for routine quality control analysis. The acid degradation product as well as pathway was characterized by LC-MS/MS.

Keywords

Doxofylline, RP-HPLC, LC-MS/MS, Degradation Studies.

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Akhilesh Gupta ¹, Jaydeep Singh Yadav ¹, Swati Rawat ², Mayuri Gandhi ³

Affiliations
1 Kunwar Haribansh Singh College of Pharmacy, Jaunpur (U.P.), IN
2 Shri Bhagwan College of Pharmacy, Aurangabad (M.S.), IN
3 IIT Mumbai (M.S), IN

Abstract

A simple, rapid and accurate RP-HPLC method was developed for the determination of doxofylline and photolytic degradation product. The method showed a linear response for concentrations in the range of 1-200 μg/ml using acetonitrile: formic acid (90:10); pH-3.0 as the mobile phase with detection at 274 nm and a flow rate of 1 ml/min and retention time 2.9 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, forced degradation, solution stability and selectivity. Quantitative and recovery studies of the dosage form were also carried out and analyzed; the % RSD from recovery studies was found to be less than 1. Due to simplicity, rapidity and accuracy of the method, we believe that the method will be useful for routine quality control analysis. The hydrolytic degradation product as well as pathway was characterized by LC-MS/MS.

Keywords

Doxofylline, RP-HPLC, LC-MS/MS, Degradation Studies.

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Swati Rawat ¹, Akhilesh Gupta ²

Affiliations
1 Shri Bhagwan College of Pharmacy Aurangabad (M.S.), IN
2 Kunwar Haribansh Singh College of Pharmacy Jaunpur (U.P.), IN

Abstract

The effect of prepared Ayurvedic formulation was evaluated on excision and incision wound models in rats. The wound-healing activity was assessed by the rate of period of epithelialization and skin-breaking strength. Histological study of the granulation tissue was carried out to know the extent of collagen formation in the wound tissue. The Ayurvedic formulation prepared was then promoted for wound-healing activity in two wound models. The treated animals showed significant reduction in the wound area up to (P<0.001) and faster rate of epithialisation (23.17±0.54). In an incision wound model, formulation treated animals demonstrated significant skin-breaking strength up to 420.33±5.92. Histological studies of the tissue obtained from the formulation treated group revealed that the activity was more significant in this group. Our present study reveals that the Ayurvedic formulation posses potent wound healing activity, which could be a good choice of remedy for wound healing but less potent than standard Nitrofurazone.

Keywords

Excision Wound, Incision Wound Model, Ayurvedic Medicinal Plants.

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Swati Rawat ¹, Akhilesh Gupta ²

Affiliations
1 Shri Bhagwan College of Pharmacy, Aurangabad (M.S.), IN
2 Kunwar Haribansh Singh College of Pharmacy, Jaunpur (U.P.), IN

Abstract

In this paper a brief history and an overview of the regulatory process for drug approval in the United States through illustrations of Investigational New Drug (INDs) Applications and New Drug Applications (NDAs), abbreviated new drug applications (ANDAs) and supplemental new drug applications (SNDAs) are provided. For INDs, the regulatory requirements for a well-designed protocol, the role and responsibility of institutional review boards, and the applicability of treatment INDs are discussed. For NDAs, issues regarding the application of expanded access, the submission of abbreviated NDAs for a generic drug, the submission of supplemental NDAs for labeling changes, and the role and responsibility of advisory committees are addressed. Along with this a brief description of review steps taken by FDA is provided.

Keywords

Investigational New Drug Application, New Drug Application, International Conference on Harmonization.

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Akhilesh Gupta ¹, Swati Rawat ²

Affiliations
1 Surgycare Lifescience, Sendhwa (MP), IN
2 SND College of Pharmacy, Yeola (MS), IN

Abstract

John Goodyew translated first reference from term ‘Dioscorides Medical treatise De Materia Medica’ into English terminology as use of Aloe vera in A.D. 1655; moreover, in early 1800s it used as laxative whereas in the mid 1930s successful treatment was introduced for chronic and severe radiation dermatitis. Since, several cultures of the history have been showed impression of foot print for use of Aloe vera, major includes Greece, Egypt, India, Mexico, Japan and China. Egyptian queens Nefertiti and Cleopatra regularly involved it in their beauty regimes whereas Alexander the Great, and Christopher Columbus used it to treat soldiers’ wounds. Aloe vera is well known plant not only in tribal community but modern lookout also make it therapeutic important. Since it is used in Ayurvedic, Homeopathic and Allopathic medicine because various research support that it contains vitamins, minerals, enzymes, amino acids, natural sugar and other bioactive compounds. Although therapeutic use of Aloe vera covered wide range of activity major includes emollient, purgative, antimicrobial, anti inflammatory, antioxidant, aphrodisiac, anti-helmenthic, antifungal, antiseptic and cosmetic, its benefits so myriad and astounding that no part in human body remains uninfluenced by its healing touch; all these make it plant of wonder. The modern therapeutic approach for beauty enhancer also list Aloe vera as most favorable plant in cosmetic industries. In this review we are trying to approach and underlying every possible corner associated with medicinal use of Aloe vera.

Keywords

Aloe vera, Wound Healing Agent, Antioxidant, Laxative, Anticancer, Anti Stress, Antidiabetic, Antidiabetic, Nutrient.

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Akhilesh Gupta ¹, Swati Rawat ², Prabhanshu Gupta ³

Affiliations
1 Surgycare Lifescience, Sendhwa (MP), IN
2 SND College of Pharmacy, Yeola (MS), IN
3 RD Memorial Ayurvedic College, Bhopal (MP), IN

Abstract

In this systematic review and meta-analysis we compared the efficacy and safety in patient with severe systemic infection (SSF) who has been either on netilmicin (NL) monotherapy or combination of netilmicin with other antibiotics (NLC). A systematic review of the literature was performed in accordance with PRISMA guidelines in Medline and Embase. A comprehensive search was performed from 1978 to 2017. Total 17 studies were identified that include 976 randomized patients with SSF. 489 patients enrolled in 11 studies for NL while 487 in NLC group. The meta-analysis showed that there was a statistically significant difference in rate of clinical efficacy (rate of failure) between NL (13.09%) and comparator NLC (20.91%). Nephrotoxicity associated with the therapy showed minor difference between both group, NL (13.80%) and NLC (10.09%). The study was further compare on the basis of dose regimen viz once a day (OD) and three times a day (TID). 184 patients of 4 studies received once in a day netilmicin monotherapy (OD-NL) while 259 patients of 7 studies received three times a day netilmicin monotherapy (TID-NL).Result of dose regimen group showed 11.04% rate of failure and 11.78% incidence of nephrotoxicity in (OD-NL) and 12.5% and 13.84% respectively in (TID-NL).The paucity of data from this evidence based systematic review and meta-analysis, favors NL monotherapy, if the slightly more chances of nephrotoxicity than comparator NLC neglected.

Keywords

Netilmicin, Sever Infection, Netilmicin Combination Therapy, Nephrotoxicity, Meta Analysis.

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Swati Rawat ¹, Shradha Sangali ¹, Akhilesh Gupta ²

Affiliations
1 SND College of Pharmacy, Babhulgaon, Yeola, Nashik, IN
2 Surgycare Lifescience, Sendhwa, M. P., IN

Abstract

Floating Drug Delivery Systems (FDDS) have a bulk density lower than gastric fluids and thus remain buoyant in the stomach for a prolonged period of time, without affecting the gastric emptying rate. While the system is floating on the gastric contents, the drug is released slowly at a desired rate from the system. These floating tablets mainly prepared for reduction of lag time and release the drug up to 12 hours and may also increase the bioavailability of the drugs by utilizing the drug to full extent avoiding unnecessary frequency of dosing. The study included formulation of floating tablets using polymers like Hydroxy propyl methyl cellulose K15M, PVP K30, Sodium bicarbonate, Xanthan-Gum, Guar-gum and microcrystalline cellulose as matrix forming agents. The tablets were directly compressed using Lab Press multi station rotary punching machine. FTIR and DSC-TGA studies conformed that there was no incompatibility between the polymers and the drug. Tablet preformulation parameters were within the Pharmacopoeias limit. Tablet showed zero lag time, continuance of buoyancy for >12 h. In vivo X-ray studies depicted that tablets continued to float in the GIT for 12 h. The in-vitro drug release pattern of Acyclovir floating tablets was fitted to different kinetic models which showed highest regression for zero order kinetics with Koresmeyer-peppasand most of the formulations followed Nonfickian diffusion.

Keywords

Acyclovi, Floating Drug Delivery System, HPMC, PVP K30, Xanthan-Gum, Guar-Gum, Matrix Devices, Gastroretentive Dosage Forms.

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