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International Journal of Pharma Sciences is an open access bi-monthly journal covering all aspects of latest research in pharmacy and pharmaceutical sciences.
2018
Volume 8, Issue-6 (November-December 2018)
ABSTRACT: Nicotine is the primary component of tobacco, and it has a number of complex and sometimes unpredictable effects on the brain. It is recognized as one of the most frequently used addictive drugs, and it is very important for tobacco users to quit (1). Nicotine can cross biological membranes, and once absorbed, it is metabolized extensively in the liver into a number of major and minor metabolites. However, buccal drug delivery offers unique and compelling benefits because it overcomes the first pass effect of the liver (6–10). One of the major challenges associated with buccal drug delivery is retention of the formulation at the mucosa. The buccal route has been used for many years to deliver drugs, which undergo first-pass metabolism. The buccal route has a relatively robust mucosa, has the advantage of allowing excellent accessibility, and reasonable patient compliance. From the present research work that is development and evaluation of Nicotine patches for buccal drug delivery using polymers such as xanthan gum, Guar gum, and karaya gum. There was no drug-excipients interaction between the drug and excipients used in the formulation.The drug was distributed throughout the patch uniformly. More than 99 % of the drug was released from all the formulation F9 at the end of 12th hrs. From the result and conclusion of the research work we can summarize that Nicotine can be delivered via buccal route.
KeyWords: Buccal Drug Delivery, Nicotine, xanthan gum, Guar gum, and karaya gum.
How to cite: Bodukum Kavya et al. Formulation and Evaluation of Nicotine Buccal Patches. Int J Pharma Sci. 8(6) 2018: 1975-1980
ABSTRACT: Pranlukast is a BCS class II drug having absolute bioavailability of approximately 4.3%. To improve the biological performance of Pranlukast solid dispersion with oral disintegrating tablets were formulated by using ß Cyclodextrin, HP ß Cyclodextrin. Solid dispersions of Pranlukast were prepared with different carriers in different ratios of drug and carrier (1:0.25, and 1:0.5). Results of prepared solid dispersions of Pranlukast by solvent evaporation method were discussed which includes solubility, melting point determination, drug content uniformity, entrapment efficiency and in vitro dissolution studies. Characterization in solid state was done by various analytical techniques such as FT-IR studies , Finally by comparing all the formulations (SF1-SF4),(KF1-KF4) formulation(SF4) containing Pranlukast+ ß cyclodextrin (1:0.5) shows better results by solvent evaporation method at the end of 90 min with drug release of 82.96%, hence it was selected as the best formulation. From the optimized formulation the immediate release tablets were formulated using different disintegrants in different concentrations. The pre compression and post compression parameters were studied and the results were given. All the results are in the acceptable limit. The in vitro drug release of the formulated tablets was performed using 6.8pH buffer. F6 formulation containing SSG (10mg) shows 98.02% drug release in 40mins. The optimized formulation follows Zero order release kinetics.
KeyWords: Pranlukast, ß Cyclodextrin, HP ß Cyclodextrin, SSG.
How to cite: A. Manasa et al. Preparation and in vitro Evaluation of Fast Disintegrating Tablets of BCS Class II Drug. Int J Pharma Sci. 8(6) 2018: 1981-1985
ABSTRACT: The purpose of the present study was to design and evaluate an Oral, site specific, Pulsatile drug delivery system containing Gliclazide as a model drug, which can be targeted to colon in a pH and time dependent manner, to modulate the drug level for maintaining blood glucose levels based on chronopharmaceutical considerations. The basic design consists of an insoluble hard gelatin capsule body, filled with powder blend and sealed with a hydrogel plug. Solid dispersions of Gliclazide were prepared using povidone and Hydroxypropyl cellulose in different ratios. From the obtained results, G6 powder blend formulation was selected for further fabrication of pulsatile capsules. Hydrogel plug was formulated in a combination of hydrophobic polymer like ethyl cellulose with hydrophilic polymers like polyox WSR in different concentrations to maintain a suitable lag period and it was found that the drug release was controlled by the proportion of polymers used. The prepared pulsincaps were evaluated for drug content, weight variation and In vitro release studies. FTIR studies confirmed that there was no interaction between drug and polymers and In vitro release studies of pulsatile device revealed that increasing hydrophillic polymer content resulted in delayed release of Gliclazide from the pulsincap after a predetermined lag time of 6hrs. Based on in vitro studies performed, F3was found to be optimized formulation.
KeyWords: Pulsatile system; colon specific; pH and time dependent delivery; Gliclazide; Chronopharmaceutics; In vitro release studies.
How to cite: A. Mounika et al. Formulation and Evaluation of Chronomodulated Pulsincap Drug Delivery System of Gliclazide. Int J Pharma Sci. 8(6) 2018: 1986-1991
ABSTRACT: Nimodipine is a dihydropyridine calcium channel blocker developed for the treatment of hypertension. Nimodipine has a half-life of 1.7-9 h, the bioavailability of 13% and it has restricted assimilation window in an upper part of the gastrointestinal tract (GIT), hence floating drug delivery system (FDDS) is favored. In this way, it is chosen to drag out the gastric home time as far as making drifting gastro-retentive medication conveyance framework to expand tranquilize ingestion and subsequently bioavailability. Subsequently, Nimodipine is picked as a reasonable contender for Gastric retentive medication conveyance framework, utilizing Gellan gum, Guar gum, and Tamarind gum. From the compatibility studies, it is concluded that the excipients used in the formulation were compatible with Nimodipine. Floating tablets were evaluated for pre compression and post compression parameters including floating studies, and in vitro dissolution studies.From the dissolution studies about it was reasoned that the detailing F3 containing Tamarind gum demonstrated better discharge compare to other formulations and it followed zero order kinetics with super caseII transport mechanism.
KeyWords: Nimodipine, Gellan gum, Guar gum and Tamarind gum.
How to cite: P. Swapna et al. Formulation and Evaluation of Gastro Retentive Floating Tablets of Nimodipine. Int J Pharma Sci. 8(6) 2018: 1992-1995
ABSTRACT: Nitrendipine modulates NMDA receptor channel function in mammalian neurons. Nitrendipine has been shown to inhibit neutrophil adhesion to vascular endothelium. It is mainly used for its antiarrhythmic, antianginal and antihypertensive activity. It is used as the prototype drug and the drug works by slowing down the rate at which calcium moves to heart and walls of blood vessels allowing better blood flow. In the present study, attempt was made to target the drug to the colon and intentionally delaying the drug absorption from the therapeutic point of view in the treatment of hypertension. Prior to formulation, Preformulation studies were carried out in order to establish compatibility between Nitrendipine and polymers like ethyl cellulose, guar gum, and HPMC K15M by FTIR spectroscopy. The results revealed that the drug and polymers were satisfactorily compatible, without any significant changes in the chemical nature of Nitrendipine. The prepared pulsincaps were evaluated for drug content, weight variation and Invitro release studies. FTIR studies confirmed that there was no interaction between drug and polymers and Invitro release studies of pulsatile device revealed that increasing hydrophillic polymer content resulted in delayed release of Nitrendipine from the pulsincap after a predetermined lag time of 6hrs. Based on invitro studies performed, F6was found to be optimized formulation.
KeyWords: Pulsatile system; colon specific; pH and time dependent delivery; Nitrendipine; Chronopharmaceutics; In vitro release studies.
How to cite: M. Vanditha et al. Formulation and Evaluation of Chronomodulated Pulsincap Drug Delivery System of Nitrendipine. Int J Pharma Sci. 8(6) 2018: 1996-2001
ABSTRACT: In the current study, a rapid, an exact and precise Ultra Performance Liquid Chromatography (UPLC) method was developed and approved for simultaneous estimation of sofosbuvir, velpatasvir and voxilaprevir in its dosage form (400 mg, 100 mg and 100 mg) by choosing chromatographic parameters. The UPLC method was developed using 100 × 3 mm, reverse phase C18 segment (Acquity UPLC CHS C18 1.7 µm) with mobile phases contain 0.01N KH2PO4 buffer and acetonitrile in the ratio of 60:40 as mobile phase and water: acetonitrile (50:50) as diluent and the run considered as an isocratic elution. Stream rate was 0.3 ml/min with UV identification at (λmax) 260 nm and the injection volume was set at 0.5 µL with run time 3 min. The method was approved by utilizing a variety of validation parameters like accuracy, precision, linearity and specificity. These results show the process could find practical application as a quality control tool for examination of the drug in its dosage form in pharmaceutical industries. The developed approved method and stability testing of new dosage forms as per ICH-Q2 (R1) and ICH-Q1C guidelines applicable for the examination of bulk drug and in its dosage form.
KeyWords: UPLC, sofosbuvir, velpatasvir , voxilaprevir, validation ad ICH.
How to cite: K. PushpaKumari et al. UPLC Analytical Method Development and Validation for the Simultaneous estimation of Sofosbuvir, Velpatasvir and Voxilaprevir in Dosage form. Int J Pharma Sci. 8(6) 2018: 2002-2008
ABSTRACT: A selective RP-HPLC method for separation and determination of potential related impurities (starting materials and by-products of synthesis, and degradants) of dabigatran etexilate (DAB) drug substance has been developed and validated. The separation was accomplished on a Zorbax eclipse XDB 100 x 4.6 mm, 3.5m. using a gradient mode by the mobile phase A: 0.63g of ammonium formate dissolved in 1000 mL of water adjust pH 8.2 with ammonia then filtered through 0.45μm filter paper and mobile phase B: mixture of acetonitrile, water (80:20v/v) and mix both mobile phase A and mobile phase B buffers in the ratio of 620:380 v/v was pumped through column at a flow rate of 1ml/min and the total elution time 50 minutes. Temperature was maintained at 30°C. Optimized wavelength for dabigatran etexilate was 300 nm. Retention time of deshexyl compound, methyl carbomate, ethyl carbomate, amide compound, dabigatram etexilate and despyridyl ethyl ester were found to be 2.466 min,4.777min,7.298min, 22.763 min, 25.089 min and 29.451 min, under gradient elution. % recovery was obtained as 0.9106%,0.9657%, 0.9029%, 0.9749%, 0.8918% and 0.9996% for Deshexyl compound, Methylcarbomate, Ethylcarbomate and Amide compound dabigatram etexilate and despyridyl ethyl ester respectively. Regression equation of Deshexyl compound was y = 11925x + 178.0, Amide compound y = 13841x +126.9, Despyridyl ethyl ester was y = 11131x + 104.1, Dabigatran etexilate was y = 11415x + 191.4, Methyl carbomate was y = 11185x + 115.7 and Ethyl carbomate was y= 11407x + 159.0.This method can be used for the quality control of both drug substance and drug product. The performance of the method was validated according to the ICH guide lines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision.
KeyWords: Dabigatran etexilate mesylate, Deshexyl compound, Methylcarbomate, Ethylcarbomate, Despyridyl ethyl ester and Amide compound, RP-HPLC, ICH guidelines.
How to cite: Saisaranya et al. Stability-indicating RP-HPLC method for determining related substances in Dabigatran etexilate mesylate drug substance. Int J Pharma Sci. 8(6) 2018: 2009-2024
ABSTRACT: In the present work, Oral disintegrating tablets of Benralizumab were prepared by direct compression method using superdisintegrants such as Crosspovidone lycoat, and Tulsion. Benralizumab has very long half-life and less bioavailability, so for enhancing the bioavailability of the drug it was formulated as oral disintegrating tablet. The dispersion time of tablets were reduced withincrease in the concentration of superdisintegrants like Crosspovidone, lycoat, and Tulsion . From the results obtained, it was concluded that Tulsion was found to be the best among the superdisintegrants, the highest drug release of F9 is 99.49% of the drug in 30 min.
KeyWords: Benralizumab, Crosspovidone, lycoat, and Tulsion, Oral disintegrating tablets.
How to cite: Srinivas Martha et al. Formulation and In Vitro Evaluation of Oral Disintegrating Tablets of Benralizumab. Int J Pharma Sci. 8(6) 2018: 2025-2028
