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m.pharm literature seminar

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Published on March 13, 2014

Author: prasandeep

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PowerPoint Presentation: R & D A Litreture review ON “EFFECT OF CONCENTRATION OF MAGNESIUM STEARATE AND VENDORS ON FORMULATION OF TABLETS FLECAINIDE ACETATE 100 mg Ph.Eur ” PRESENTED BY: PRASANDEEP BISWAL M.PHARM-2 nd Year PHARMACEUTICS REGD.NO-1161651012 Under the Joint Guidance Of Dr.Snigdha Pattnaik Mr. Ashok b Cheware Associate Professor Manager Dept.of Pharmaceutics (Q& A) SCHOOL OF PHARMACEUTICAL SCIENCES CIRON DRUGS PVT. LTD. S ‘O’ A UNIVERSITY MUMBAI. c ciron A LITERATURE REVIEW ON PowerPoint Presentation: INTRODUCTION A tablet is a mixture of active substances and excipients, usually in powder form ,then pressed or compacted into a solid. There are 3 interrelated groups of tablet excipients anti- adherants , glidants and lubricants to ensure efficient tableting; these are used to promote granule flow & minimize die wall friction. However a lubricant may be defined as a suitable material interposed between 2 rubbing surface will reduce friction arising at the interface. An ideal lubricant should reduce friction effectively with no adverse effects upon formulation. It should be inert and acceptable with respect to other dosage form ingredients. The ideal lubricant should be Unaffected by changes in process variables. Consistent from batch to batch. Readily available and cheap. PowerPoint Presentation: Aim: The aim of present work is to determine the optimum concentration of magnesium stearate and to sketch out the effect of concentration and vendor in the formulation of Flecainide acetate 100mg Ph.Eur resulting in a formulation giving simulated effect as that of the innovator. To find out the optimum concentration of magnesium stearate and it’s effect on physicochemical parameters and in-vitro drug release. To study changes that may occur in the post compression parameters and release pattern of drug by variation in concentration of magnesium stearate. Objective : AIM & OBJECTIVE PowerPoint Presentation: DRUG PROFILE: Name of active drug : Flecainide acetate Molecular structure : Fig.no: 13 molecular structure of Flecainide acetate IUPAC Name : N-(piperidin-2-methyl)-2,5-bis(2,2,2-trifluoroethoxy) benzamide Molecular formula : C 17 H 20 F 6 N 2 O 3 Molecular weight : 414.3427 pH : 6.7 pKa : 9.3 Plasma half-life : 11.5 – 16 hours Bioavailability : Approximately 85 – 90%. Plasma protein binding: Approximately 40 % (Albumin) BCS Class : Class I Drug LOD : NMT 0.5% Standards : NLT 98.0% and NMT 101.0% Description : white hygroscopic crystalline powder. Solubility : Soluble in water and in anhydrous ethanol. Freely soluble in dilute acetic acid. Dose [orally] : 50/100/150mg/daily PowerPoint Presentation: (1)This study was carried out to determine the effect of different venders of manufactured Magnesium stearate (Nitika, Ferro, Peter Grevens) on the sildenafil citrate tablets properties like thickness, hardness, disintegration time and dissolution with a range of extra granular magnesium stearate from.0.5%, 1% 1.5 %.Here the amount of intragranular magnesium stearate was held constant. Sildenafil citrate tablets have been prepared by dry granulation method. Micro crystalline cellulose, Di basic calcium phosphate was used as diluents. Croscarmellose sodium was used as super disintegrant. Colloidal silicon dioxide as a glidant and magnesium stearate was used as lubricant. The analysis of the active constituents was followed by the study of drug release profile at various time points for all formulations. This study concluded that the suitable vendor and 1% of magnesium stearate for the successful formulation. DETERMINATION OF EFFECT OF MAGNESIUM STEARATE ON SILDENAFIL CITRATE TABLETS. V.SANDHYA*et al. PowerPoint Presentation: (2)This article is giving emphasis on the decisive role of particle size of highly hydrophobic lubricant i.e. Magnesium Stearate, its concentration and lubrication time to establish the desired quality attributes of formulation containing highly soluble model drug Metformin Hydrochloride. Magnesium Stearate from two sources with different Particle size distribution (PSD) range was selected. It was observed that the Magnesium Stearate with a designed PSD is controlling the drug release profile of Metformin hydrochloride Tablets, which can replace the use of excess quantity of Magnesium Stearate in the formulation design. it concluded that tablets containing Mg.st of larger particle size showed highest drug release and tablets of smaller particle size of Mg.st showed a slower drug release and suggested that selecting of an appropriate particle sized Mg.st along with other properties like concentration on can achieve desired release profile. Critical roles play of magnesium stearate in formulation development of a highly soluble drug Metformin hydrochloride. Meenakshi Shadangi et al., PowerPoint Presentation: Binary Effects of Magnesium Stearate and Talc as Dissolution Retardants at 85% Drug Loading in an Experimental Extended-Release Formulation THOMAS DU¬RIG et al.   (3)The feasibility of producing extended-release matrix tablets with high drug loadings (80-90% w/w) containing a binary combination of magnesium stearate (MS) and talc (T) at different levels as major dissolution retardants was investigated. Matrix tablets were prepared from a granulation containing theophylline, starch, hydroxypropylcellulose, and varying amounts of MS and T. Using a 3² factorial design, the effect of MS and T on the physical properties and drug release characteristics of the tablets was evaluated. The analysis showed that the binary combination of MS and T at levels >3% adversely affected both tensile strength and friability. A parabolic relationship was observed for the increase in time required for the release of 50% of the theophylline (t50%) with increased MS levels. Moreover, as the proportion of MS and T was increased, the release profiles became more linear. A combination of 3% MS and T provided both near zero-order release kinetics as well as a coherent matrix structure. Based on model fitting, a release mechanism combining diffusion and matrix dissolution is proposed. It may be concluded that in the development of controlledrelease systems, the binary combination of MS and T at levels exceeding those conventionally used for lubrication can be employed as an inexpensive, low bulk dissolution retardant for formulations with high drug loading. PowerPoint Presentation: (4)Most pharmaceutical formulations also include a certain amount of lubricant to improve their flowability and prevent their adhesion to the surfaces of processing equipment. Magnesium stearate is an additive that is most frequently used as a lubricant. Magnesium stearate is capable of forming films on other tablet excipients during prolonged mixing, leading to a prolonged drug liberation time, a decrease in hardness, and an increase in disintegration time. It is hydrophobic, and there are many reports in the literature concerning its adverse effect on dissolution rates. The objective of this study was to evaluate the effects of two different concentrations of magnesium stearate on dissolution properties of ranitidine hydrochloride coated tablet formulations labeled to contain 150 mg. The uniformity content was also checked. During the drug formulation development, several samples were designed for choice of the formulation. For this study, two formulations containing 0,77 and 1,1% of magnesium stearate added in the manufacture of cores were chosen. Fraction of ranitidine hydrochloride released in dissolution medium was calculated from calibration curves. Th e data were analysed using pharmacopeial test for similarity of dissolution profiles ( f2 equation), previously proposed by Moore and Flanner. Application of f2 equation showed differences in time-course of ranitidine hydrochloride dissolution properties. Th e obtained values indicate differences in drug release from analysed ranitidine hydrochloride formulations and could cause differences in therapeutic response . Effect of Magnesium stearate concentration on dissolution properties of ranitidine Hydrochloride coated tablets. Alija Uzunović1*,et al. PowerPoint Presentation: (5) HereThis study investigated the change of lubrication effect of mag.st when the mixing time and scale were altered. The crushing strengths of tablets, which were compressed from the mixed powders, were used as secondary response for lubrication effect. Binary mixtures of microcrystalline cellulose and mg.st were mixed in three scales: laboratory (1 l), pilot (10 l) and production scale (80 l). Two parallel batches were mixed in every scale. The aim was to constitute a relationship between the mixing time of the powders and the crushing strength of the tablets. With pilot and production scale this decrease was greater than with laboratory scale. The effect of mixing time of the magnesium stearate on crushing strengths of tablets. Satu Virtanen et al., PowerPoint Presentation: (6) The effects of granule size and concentration of magnesium stearate as lubricant on the dissolution rate of paracetamol tablets were studied. The results obtained show that dissolution rate was increased as the granule size of the tablet was increased for tablets prepared with 1.5% magnesium stearate as lubricant. However, tablets prepared with different granule size, exhibited no pronounced effect on the dissolution characteristics when concentration of magnesium stearate was used as 0.75%. Influence Of Granule Size And Lubricant Concentration On The Dissolution Of Paracetamol Tablets. S.C Basak et al. PowerPoint Presentation: (7)It proposed that that co-grinding of drug with a hydrophobic carrier has the potential to be optimized for the reduction of drug dissolution rate and thereby production of sustained release systems. In the present study Na-diclofenac was co-ground with Mg.st. Various concentrations of Mg.st were used to investigate the effect of carrier concentration on drug release. Dissolution test was carried out at pH 7 .2 for determining of drug dissolution rate from prepared formulations. The release rate of drug from co-ground samples was compared to that of from physical mixture formulations. X-ray crystallography, DSC and FT-IR were used to investigate the formation of any complex between drug and carrier or any crystallinity changes during the manufacturing process. The results showed that all co-ground samples demonstrated slower release rates Decreased dissolution rate was observed with increasing of Mg.st concentration. This could be due to the presence of more hydrophobic particles. Then co-grinding of water soluble drug (Na-diclofenac) with hydrophobic carrier (Mg.st) could be used to retard drug release and thereby production of sustained release systems. Evaluating retardation and physicochemical properties of co-ground mixture of Na- Diclofenac with Magnesium stearate. Yousef Javadzadesh et al PowerPoint Presentation: (8)It concluded that Over mixing of Mg.st with granules in the hopper of a capsule filling machine can slow down their dissolution because of coating by Mg.st, which acts as a water repellant .When capsules of an aqueous wet granulated formulation containing one of the aforementioned active ingredients, hydrous lactose, Pregelatinized starch, microcrystalline cellulose, and 1% w/w Mg.st were filled using the MG2 Futura capsule filler, capsules from the latter part of the filling run exhibited significantly slower dissolution compared to those from the beginning. . Further study by using the active ingredient indicates that replacement of Mg.st in the formulation with other hydrophobic lubricants such as calcium or zinc stearate gave similar results Replacement of Pregelatinized starch by starch-derived super-disintegrant ’ s resulted in no slowing of dissolution of capsules, even after over mixing with 1% w/w Mg.st. Although the granules over mixed with 1% w/w hydrophobic lubricants exhibited slowdown in dissolution when filled into capsules, tablets compressed from these granules dissolved rapidly. Physical interactions of magnesium stearate with starch-derived disintegrant’s and their effects on capsule and tablet dissolution . D.S Desai et al., PowerPoint Presentation: References: V.SANDHYA*, N.SRI RAM1, VINAY UMESH RAO ,“DETERMINATION OF EFFECT OF MAGNESIUM STEARATE ON SILDENAFIL CITRATE TABLETS” ; international journal of advanced pharmaceutics ; vol-2;issue-1;2012;page no.1-4. Meenakshi Shadangi , Saurabh Seth* and Deepak Senapati ., “Critical roles play of magnesium stearate in formulation development of a highly soluble drug Metformin hydrochloride”; international journal of pharmaceutical sciences and research ; vol-3;issue-04;2012;page no-1188-1193. THOMAS DU¬RIG . REZA FASSIHI , “Binary Effects of Magnesium Stearate and Talc as Dissolution Retardants at 85% Drug Loading in an Experimental Extended-Release Formulation”; journal of pharmaceutical sciences ; vol-86(10);1997;page no.-1092-1098. Alija Uzunović1*,ADINA VRANIC.,“Effect of Magnesium stearate concentration on dissolution properties of ranitidine hydrochloride coated tablets”; european journal of pharmaceutical seciences ;vol-7(3);2012;page no.279-293. Satu Virtanen et al .,“ The effect of mixing time of the magnesium stearate on crushing strengths of tablets”; european journal of pharmaceutical seciences ; 2008: VOL-34(1):page no.27 . S.C Basak , T Sivakamasundari , S Sivagamasundari , R Manavalan “Influence Of Granule Size And Lubricant Concentration On The Dissolution Of Paracetamol Tablets”, journal of pharmaceutical seciences Year : 2003  |  Volume : 65  |  Issue : 3  |  Page : 299-301 Yousef Javadzadesh , Khosro Adibakia , Zahra Bozorgmehr )“ evaluating retardation and physiochemical properties of co-ground mixture of Na- diclofenac with magnesium stearate ” european journal of pharmaceutical seciences : (march 2012 volume 218; page 51-56. D.S Desai, B.A.Rubitiski , S.A.Varia “Physical interactions of magnesium stearate with starch-derived disintegrant’s and their effects on capsule and tablet dissolution” international journal of pharmaceutics; 1993;91(2-3):217-223.

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