Cross Carmellose Sodium Research Articles

Compatibility Studies of Atorvastatin Calcium with Selected Excipients By Means of Thermal and FT-IR Spectroscopic Methods for the Development of Immediate Release Tablet

The objectives of present investigation is to evaluate the compatibility of Atorvastatin calcium with immediate release excipients and to optimize the tablet which release is best comparable with innovator product by varying different super disintegrants. Various excipients used were sodium starch glycollate, cross carmellose sodium, cross-povidone, lactose, micro crystalline cellulose, mannitol, sodium lauryl sulfate, magnesium stearate, and stearic acid. Thermal characterization of the drug was done by DSC and FT-IR. From the DSC studies, the excipients such as microcrystalline cellulose (Avicel 101), magnesium stearate, mannitol, sodium lauryl sulfate were found to have physical interactions with Atorvastatin. Immediate release tablet was prepared by direct compression method and its release profile was compared with the marketed IR tablet. The prepared tablet have conform the pharmacopoeial limit for hardness, thickness, friability, weight variation and content uniformity. Formulation F11 containing two super disintegrants have shown the disintegration time less than 25 sec and better dissolution than all other formulations releasing more than 80% of the drug after 20 minutes. Kinetic data reveals that the drug release follows best order by Higuchi model, followed by korsemeyer peppas, zero order and first order mechanisms. The results of accelerated stability studies as per ICH guidelines indicated that the tablet was stable as there were no any significant physical changes after the study.

FORMULATION DEVELOPMENT AND EVALUATION OF FAST DISSOLVING TABLET OF TRIPTAN DRUG

Almotriptan malate is a triptan class anti-migraine drug with rapid action, highest bioavailability and low side effects. Fast dissolving tablets of almotriptan malate were prepared by wet granulation technique using sodium starch glycolate, Crosscarmellose sodium and Crosspovidone (2%, 4%, and 6%), respectively, FT-IR spectroscopy and differential scanning calorimetry were used to investigate the physical characteristics of the drug. The granules were examined for angle of repose, bulk density, tapped density, index and Hausner’s ratio. Developed tablets were evaluated for hardness, drug content, friability, wetting time, wetting absorption ratio, in vitro drug release and disintegration time. Formulation with 4% crosspovidone showed disintegration time of 21.5 sec. In vitro dissolution studies showed drug release of 94.66% after 12 minutes. The drug release from the formulation followed zero order kinetics. The optimized formulation was found to be promising and can be considered for further study.

FORMULATION AND OPTIMIZATION OF VARDENAFIL HYDROCHLORIDE ORAL DISINTEGRATING TABLETS: EFFECT OF SUPERDISINTEGRANTS

One of the fruitful results of oral technological advancement in dosage forms is the orally disintegrating tablets (ODTs) as they disintegrate rapidly in the mouth and do not require water for administration. This work employed mixture design approach for developing and optimizing oral disintegrating tablets of a slightly water soluble drug, vardenafil hydrochloride. Three component mixture design was used to optimize the type and concentration of superdisntegrants, crosscarmellose sodium (X1), crosspovidone (X2) and sodium starch glycolate (X3) using water soluble dextrates (Emdex®) as a filler. Disintegration time, wetting time and t90 values for all formulations ranged from 33.69 to 208.68 s, 40.42 to 209.83 s and 80.04 to 484.63 s, respectively. According to the results, the selected variables have a strong influence on disintegration time, wetting time and t90 of the ODTs. The lowest disintegration time, wetting time and t90 were showed by ODTs formula composed of 1.72 % of crosscarmellose in combination with 4.28 % of crosspovidone. So, this formula was chosen as the optimized formula. Stability studies also showed that the optimized formula was stable under accelerated conditions. And, by comparing the selected formula with Prosolv® ODT G2 as a ready ODT system, it showed faster disintegration time and higher dissolution rate. Hence, the best superdisintegrants to be used with the water soluble dextrates are crosspovidone in combination with crosscarmellose sodium.

DEVELOPMENT AND OPTIMIZATION OF CHRONOPHARMACEUTICAL DRUG DELIVERY SYSTEM FOR ASTHMA

The present research was designed to increase bioavailability and solubility of Montulokast Sodium by formulating Chrono pharmaceutical delivery system. In the present study firstly immediate release core tablets were prepared by direct compression using Response Surface Methodology with different superdisintegrants, diluents and surfactants to release drug faster. In that formulation containing cross carmellose sodium and Poloxomer-188 with highly soluble lactose gave 95% release in 30 minutes with optimum pre & post compression characteristics. Chronopharmaceutical Drug delivery formulations were then prepared by press coating using polymers as Xanthan gum, Polyox, HPMC & Ethyl Cellulose alone and in combination. The results revealed that combinations of these polymers give better lag time rather than using a single polymer.Thus it can be concluded that combining hydrophilic and hydrophobic polymer can be done to achieve the respected lag time required for pulsatile release.

Formulation and Evaluation of Fast Dissolving Tablets of Trimetazidine Dihydrochloride Using Natural and Synthetic Superdisintegrants

Plant products serve as an alternative to synthetic products because of local accessibility, eco friendly nature and lower price compared to imported synthetic products. Natural gums and mucilage have been widely explored as pharmaceutical excipients. Tablet disintegration has received considerable attention as an essential step in obtaining fast drug release. The present work was carried out to study the disintegration properties of Plantago Ovata mucilage powder by formulating orally disintegrating tablets of Trimetazidine hydrochloride by direct compression method. Disintegrant property of above disintegrants was evaluated by comparing their formulations with the formulations of various superdisintegrants extracted Mucilage was subjected to toxicity studies for its safety and preformulation studies for its suitability as a disintegrating agent. The extracted mucilage is devoid of toxicity. No chemical interaction between drug and excipients was confirmed by FTIR and DSC studies. Mouth dissolving tablets of Trimetazidine hydrochloride were prepared and compared with different concentrations viz; 0.5, 1, 1.5, 2.0 and 2.5% (w/w) of Plantago Ovata mucilage powder, cross carmellose sodium and sodium starch glycolate. Thirty six formulations were prepared by using different diluents and evaluated for physical parameters such as thickness, hardness, friability, weight variation, drug content, disintegration time and drug dissolution. The formulated tablets had good appearance and better drug release properties. The study revealed that Plantago Ovata mucilage powder was effective as disintegrant in low concentrations (1%). The mucilage was found to be a superior disintegrating agent than sodium starch glycolate and cross carmellose sodium. Studies indicate that the extracted mucilage may be a good source of pharmaceutical adjuvant, specifically a disintegrating agent.

Designing of Fast Disintegrating Tablets for Antihypertensive Agent Using Superdisintegrants

The aim of present study was to formulate and evaluate Fast dissolving tablet (FDT) of Enalapril maleate. FDT of this drug improved efficacy by minimizing the disintegration time and by providing fast release. FDT of Enalapril maleate, using different superdisintegrants like sodium starch glycolate, cross carmellose sodium and other excipients like mannitol, microcrystalline cellulose, magnesium sterate and talc by direct compression technique. All the optimized formulations were characterized on the basis of post-compression parameters, such as determination of disintegration time, in-vitro dispersion time, drug content, in-vitro dissolution study, wetting time, water absorption time,. Formulation F6 containing crospovidone (20%) with appropriate amount of other excipients was considered to be the optimized formulation with desired drug content 99.48%, wetting time 11.68±1.21 second, water absorption time 86.28±0.62 second, in-vitro disintegration time 13.68±1.68. FDT rapidly dissolve in oral cavity within 13.68 second without need of drinking water, had a pleasant mouth feel with improved patient compliance, particularly for those who have difficulty in swallowing like paediatric and geriatric patients. In-vitro drug release showed fast behaviour of F6 formulation. All the physical and chemical parameters were found to be in acceptable range and fulfil the entire requirement for FDT.

Formulation and Evaluation of Montelukast Sodium Fast Dissolving Tablets

Montelukast sodium is an anti-asthmatic, mainly prevents leukotriene mediated effect associated with asthma. Mouth dissolving tablets of montelukast sodium was prepared by direct compression method using superdisintegrants such as croscarmellose sodium, crospovidone and sodium starch glycolate. Mouth dissolving tablets (MDTs) disintegrates or dissolves rapidly without water within few seconds in the mouth due to the action of superdisintegrants or maximizing pore structure in the formulation. The tablets were prepared using various diluents like MCC, Lactose and superdisintegrants namely Crosscarmellose sodium, Crosspovidone and Sodium starch glycollate in different concentrations. Pre-compression parameters such as angle of repose, bulk density, tapped density, compressibility index, Hausner's ratio were carried out to study the flow properties of powder to achieve uniformity of tablet weight and the values were within permissible limits.The prepared tablets were evaluated for hardness, thickness, weight variation, friability, % drug content, wetting time, water absorption ratio, in vitro disintegration time, in vitro dispersion time and in vitro drug release.The formulation M12 and L12 was found to be the best on the basis of wetting time, in vitro disintegration time and in vitro drug release. Stability studies were carried out at 25°C±2°C/60%±5% RH and 40°C±2°C/75%±5% RH for a period of 60 days for the selected formulations. The formulation M12 and L12 containing Crospovidone (8%) as superdisintegrant and microcrystalline cellulose and lactose as diluents was respectively found to be the optimized combination.

Formulation and Evaluation of Immediate Release Pravastatin Sodium Tablets

The objective of this research was to formulate fast dissolving tablets of Pravastatin sodium that disintegrate in the oral cavity upon contact with saliva and there by improve therapeutic efficacy. Pravastatin sodium is used for the treatment of myocardial infarction. Fast dissolving tablets of pravastatin sodium were prepared by direct compression method using three different superdisintegrants-Sodium starch glycollate, Crosscarmellose sodium and Crosspovidone (2%, 4% and 6%) and three different diluents (mannitol and spray dried lactose) in different concentrations. Eighteen formulations were prepared by using different diluents and evaluated were evaluated for various pre and post compression parameters like angle of repose, bulk density, tapped density, compressibility index, Hausner's ratio, tablet hardness, friability, weight variation, wetting time, water absorption ratio in vitro dispersion time, drug content and in vitro dissolution studies. FTIR and DSC studies revealed that there was no chemical interaction between the drug and the excipients. Formulation L6 was found to be the best on the basis of wetting time, in vitro disintegration time and in vitro drug release. The formulation L6 containing spray dried lactose as diluent and crosspovidone (6%) was found to be the optimized combination. Stability studies were carried out at 250°C±20°C/60%±5% RH and 400°C±20°C/75%±5% RH for formulation L6 for 60 days. The results of stability studies indicated no significant changes with respect to physicochemical properties, in vitro disintegration time, wetting time and in vitro drug release.

FORMULATION AND EVALUATION OF MOUTH DISSOLVING TABLETS OF RANITIDINE HYDROCHLORIDE

In present research work, taste masked Mouth Dissolving Tablets (MDTs) of Ranitidine Hydrochloride were designed with a view to enhance the patient compliance and provide a quick onset of action. Taste masking of the drug was done by formation of complex with β cyclodextrin. Tablets were prepared by direct compression, using superdisintegrants like crosscarmellose sodium and crosspovidone in different proportion and evaluated for the pre-compression parameters such as bulk density, compressibility, angle of repose etc. In view of the better taste palatability of such a bitter API, taste masking was carried out via making the cyclodextrin complex and sucralose was used as the sweetener to impart a palatable taste to the formulation. The prepared batches of tablets were evaluated for hardness, weight variation, friability, drug content, disintegration time and in vitro dissolution profile and found satisfactory. Among all, the formulation F7 containing 5% w/w proportion of both crosscarmellose sodium and crosspovidone was considered to be best formulation, which disintegrated completely in 19 seconds and released up to 98.38% of the drug.

Formulation and Evaluation of Mouth Dissolving Tablets of Piroxicam

Piroxicam, a non-steroidal anti-inflammatory agent, is widely used in rheumatoid arthritis, osteoarthritis, musculo-skeletal disorders, dysmenorrhoeal and post-operative pain. It has poor bioavailability due to its inherent properties. The objective of present study is to enhance water solubility of Piroxicam by solid dispersion technique and to develop novel method of preparing compressed tablets for Piroxicam with high porosity which dissolves rapidly in mouth, using camphor as sublimating agent and super disintegrants such as Crosscarmellose sodium and sodium starch glycollate. The tablets were evaluated for hardness, thickness, friability, weight variation, wetting time, disintegration time, drug content and in vitro drug release. Optimized formulation was evaluated for stability according to ICH guideline. All tablets had hardness in range of 2.8-3.1 kg/cm2 and friability of all formulations was less than 1.0%. Weight variation and drug content were within USP limits. A stability study for optimized F6 formulation 40 °C / 75 % RH for 30 days showed little change in drug content. Therefore, it is concluded that enhance solubility and increased levels of the super disintegrants Cross carmellose sodium and sodium starch glycollate increases the rate of Piroxicam release. Camphor decreases disintegration time of tablets and create high porosity which dissolve rapidly in mouth and could be industrially feasible.

New Easily Swallowed Tablets with Slippery Coating for the Antihypertensive Drug Valsartan

Different tablet dosage forms were prepared to be administered for patients with dysphagia (swallowing difficulties) like buccal, sublingual and orodispersible tablets, however, they possesses certain constrains like taste masking difficulties, limitations in drug and dose selection and friability. Hence, in an attempt to overcome these constrains, a new easily swallowed immediate release tablets containing (160mg) Valsartan were prepared, and designed to be slippery upon contact with saliva giving an easy swallowing of the intact tablet (without water) with efficient taste masking effect, thus, they called Oroslippery tablets (OSTs). Core tablets were prepared by direct compression using different superdisintegrants, followed by dipping in special coating dispersion containing different proportion of kollicoat IR (film former) and xanthan gum (slipperiness inducer) at different coating levels. These OSTs were optimized for their physical properties, in-vitro disintegration and release in addition to in-vivo slipperiness and taste masking effect. It was found that F12 containing 6% crosscarmellose sodium double coated with 15% kollicoat IR and 0.3% xanthan gum possessed a good mechanical strength (hardness=5.69±0.58 Kg/cm2, friability=0.09%±0.79), suitable in-vivo slipperiness and taste masking times (8±1.45 and 58±2.18 seconds) respectively, with longer disintegration time (5.57±1.36 minutes) but similar release profile to the commercial conventional tablet Diovan® with similarity factor (f2= 68.4±1.07) and difference factor (f1= 1.39± 0.95). Therefore, this study developed a new easily swallowed tablet with an efficient taste masking property, high loading capacity and adequate mechanical strength that can be used as an alternative to buccal, sublingual and orodispersible tablets.

Formulation and Evaluation of Liquid Loaded Tablets Containing Docetaxel-Self Nano Emulsifying Drug Delivery Systems

Purpose: To prepare and characterize tablets loaded with self-nanoemulsifying drug delivery system (SNEDDS) containing docetaxel (DTL).Method: SNEDDS of docetaxel were prepared using various oils, surfactants, co-surfactant and solvents to improve the dissolution rate and bioavailability of the poorly water-soluble chemotherapeutic agent. The SNEDDS components were preliminarily screened for the solubility of the drug in various vehicles, miscibility of excipients, rate of emulsification and ternary phase diagrams. The tablets were prepared by direct compression process with a porous carrier, magnesium alumino-metasilicate, and subsequently loaded with SNEDDS by a simple absorption method. The tablets were then characterized for physical parameters, including tablet hardness, weight variation, disintegration, drug content and invitro drug release.Results: Cremophor-EL, polysorbate-80 and dehydrated alcohol mixture in the ratio 85:10:5 yielded docetaxel SNEDDS with droplet size of 12.16 nm and polydispersity (PDI) of 0.039. Tablets with high porosity suitable for loading with SNEDDS and containg the super-disintegrants, crosscarmellose sodium and sodium starch glycolate, in a concentration of 3, 4 and 5 %, achieved complete dissolution of docetaxel from the tablets. In vitro release of docetaxel from SNEDDS and the tablets was similar (p < 0.05).Conclusion: SNEDDS of docetaxel is a promising approach to achieving a solid dosage form of the liquid-loaded drug delivery systems for enhancing the solubility and dissolution rate of the drug, and hence also its bioavailability.Keywords: Docetaxel, Drug carrier, SNEDDS, Self-nanoemulsifying, Solubility, Drug release, Anicancer, Surfactant, Co-surfactant

Enhancement of dissolution rate of Clofibrate BCS Class –II drug by using liquisolid compact technology

The aim of this study was to improve the dissolution rate of the poorly soluble drug Clofibrate by delivering the drug as a liquisolid compact. Liquisolid compacts were prepared using propylene glycol as solvent, Microcrystalline cellulose as carrier, Starch and Lactose are used as a coating materials. Sodium starch glycolate and Cross carmellose sodium are used as a Super disintigrants. The crystallinity of the newly formulated drug and the interaction between excipients was examined by X-ray powder diffraction and Fourier-transform infrared spectroscopy, respectively. The dissolution studies for the liquisolid formulation and the Conventional tablet were carried out at a pH 6.8 buffer. The results showed no change in the crystallinity of the drug and no interaction between excipients. The dissolution efficiency of Clofibrate at 60 min was increased from 71.02% for plain drug and 81.3% for Conventional Tablet to 100.47% for the liquisolid formulation. The increase in the dissolution rate was also found to be significant compared to the pure drug and Conventional Tablet at pH 6.8 buffer. The liquisolid technique appears to be a promising approach for improving the dissolution of poorly soluble drugs like Clofibrate.

Dissolution rate improvement of telmisartan through modified MCC pellets using 32 full factorial design

Context: Microcrystalline cellulose (MCC) is the most widely used excipient for the production of pellets but it retards the release of poorly water soluble drugs. Objective: The present investigation reports incorporation of camphor, cross carmellose sodium (CCS) and spray dried lactose (SDL) into MCC pellets to enhance the dissolution rate of telmisartan. Materials and methods: A full factorial design (32) was used in the study. Concentration of camphor and CCS was selected as independent variables whereas percentage porosity and percentage drug release at 60min were selected as dependent variables. Pellets were produced by extrusion–spheronization technique and evaluated for percentage yield, particle size analysis, flow characteristics, percentage porosity, drug content and in vitro drug release. Contour plots and 3-D surface plots were presented for graphical expression of the results. Results and discussion: Pellet formulations exhibited acceptable morphological, flow and mechanical properties. As against to 38.54% drug release after 60min with MCC pellets, pellets prepared with optimized formulation, composed of proper combination of MCC, SDL, camphor and CCS, released 100% drug after 60min. Conclusion: Our study underlines the fact that dissolution of telmisartan from MCC pellets can be successfully enhanced by incorporating water soluble excipient, disintegrant and pore formers.

Formulation and evaluation of Nateglinide dispersible tablet by direct compression method

The study was carried to formulate and evaluate dispersible tablet dosage form obtaining Nateglinide.Nateglinideis adrugfor the treatment oftype 2 diabetes. The present study is an attempt to select best possible combination of diluents and disintegrates to formulate dispersible tablet of Nateglinide which disintegrates within few minutes thereby reducing the time of onset of action. Mannitol is selected as diluents, Sodium starch glycol ate, Cross-povidone, cross-carmellose sodium were selected as super disintegrates, citric acid and sodium bi carbonate is effervescent active ingredient in different concentrations. Aspartame as a sweetening agent, Magnesiumstearate as a Lubricant and glidant.Direct Compression method was used to formulate the tablets.All the formulations were showed the acceptable flow properties and the pre-compression parameters like Bulk density, Tapped density and Hausner ratio. The post compression parameters like Hardness, Friability, Disintegration time, Weight variation, wetting time, Dispersion time values were found to be within the IP limits.The percentage Drug content of all tablets was found to be between 99% - 100 % of Nateglinide, which is within the limit.As the concentrations of the Citric acid (preservative) & sodium bicarbonate (active ingredient respectively taking increases in the formulations F7 F9 the disintegration time found to be decreased and the disintegration time for these formulations were 33, 31, 30 seconds respectively and the percentage drug release was also found to be increased for these formulations as 94 ,96, and 99 % respectively. From the above results it was found that as the concentration of citric acid decreased and sodium bi carbonate increases the disintegration and dissolution time was found to be improved, so considering the above results it was found that the F9 batch was found to be optimized batch and it pass all the pre-formulation parameters and evaluation results as per the IP limits.

Development and Evaluation of Bilayer Tablet of Metoclopramide HCl and Aceclofenac

Bilayer tablets are basically used to administer a dosage form with dual release effect or to formulate two incompatible drugs. The main objective of the present research work was to prepare bilayer tablet of Metoclopramide hydrochloride (MTH) and Aceclofenac (ASF) for separate layers to avoid the degradation of the drug, with the desired release pattern and thus to maximize the efficacy of both drugs in combination for the effective treatment of migraine. MTH and ACF were formulated as immediate and conventional release layer respectively. ASF was formulated as conventional release layer using PVP K-30 and MCC as binder and disintegrants respectively. MTH was formulated as immediate release layer by using various disintegrants like Sodium starch glycolate (SSG), Cross carmellose sodium (CCS) and Pre-gelatinized starch (PGS). Mixture design technique was used to find out the optimized quantity of the super disintegrants. Disintegration time (DT) and drug release at 15 min (Rel15min) were taken as dependent variables while quantity of super disintegrants was taken as independent variable. SSG and CCS in a concentration of 7.5% and 4.5% respectively gave a DT of 9 sec, and 98.67% release at 15 min (Rel15min). Stability studies of bilayer tablets as well as physical mixture were carried out and the samples were evaluated with DSC, FT-IR and % content of drug. Bi-layer tablet was suitable for preventing direct contact of these two drugs and thus to maximize the efficacy of combination of two drugs for migraine.

Formulation Development and Evaluation Bilayer Floating Sustained and Immediate Release Tablet of Verapamil Hydrochloride by Direct Compression Method

In the current study a successful attempt was made to formulate Bilayer Floating tablets of Verapamil Hydrochloride by direct compression method containing loading dose, superdisintegrants in immediate release layer and maintenance dose, rate controlling polymers and gas generating agents in floating layer. Floating tablets of Verapamil Hydrochloride was prepared using HPMC K4M, HPMC K15M and Xanthum gum in different ratios for optimizing the floating layer of bilayer floating tablets. The optimized floating tablets which was used further to formulate bilayer floating tablets contains HPMC K4M or HPMC K15M and Xanthum gum in the ratio of 3:2 showed shortest buoyancy lag time with more than 24 h total buoyancy time and in-vitro drug release was more rapid compared to floating tablets containing Xanthum gum, HPMC K4 M, HPMC K15 M alone. Various physicochemical properties of Bilayer floating tablets were within the pharmacopoeial limits thus showing good mechanical strength and content uniformity of tablets. The relative efficiency of superdisintegrants in enhancing the disintegration and dissolution rates of tablets was found to be in the following order: Crosscarmellose sodium > Sodium starch glycolate > Micro crystalline cellulose. Formulation BLF2 containing 5% Crosscarmellose sodium in the immediate release layer, HPMC K4M and Xanthum gum in the ratio of 3:2 in the floating layer showed highest in-vitro drug release and it followed Higuchi as predominant mechanism of drug release. Therefore, it was considered as the best formulation.

Formulation and Evaluation of Fast Dissolving Tablet of Drug Used In the Treatment of Motion Sickness

Fast dissolving tablets are those that dissolve or disintegrate quickly in the oral cavity, resulting in solution or suspension. In the present study Fast dissolving tablet of Scopolamine Hydrobromide was prepared by direct compression method using Indion 414, Cross Carmellose Sodium and sodium starch glycolate as superdisintegrants. The tablets prepared was evaluated for various parameters like various density parameters, thickness, hardness, friability, disintegration time, wetting time and in-vitro dissolution time. All the parameters were found to be within limits. Indion 414 as superdisintegrant gives better result as compared to crosscarmellose sodium and Sodium starch glycolate. Tablets disintegrate within 30 sec in mouth having better mouth feel. The developed formulation of Scopolamine Hydrobromide batch F5 (10% Indion 414) showed good palatability and dispersed within 30 seconds as compared to Cross Carmellose Sodium and Sodium starch glycolate.

Design, Development and Evaluation of Solifenacin Succinate Tablets

Solifenacin Succinate is used in the treatment of over active bladder with symptoms of urge urinary incontinence, urgency, and increased urinary frequency, and anti spasmodic. Solifenacin Succinate was launched in 2005 and has been shown in both short and long term clinical trials to fulfill these requirements. Solifenacin is a competitive M3 receptor antagonist with a long half-life (45–68 hours). It is available in two dosage strengths namely a 5 or 10 mg once-daily tablet. Ten different trial batches were carried out using different concentrations of excipients like binder (Methocel E5 premium LV), super disintegrant (sodium starch glycolate, cross carmellose sodium, cross povidone), lubricant (Magnesium stearate), glidant (Aerosil) by direct compression technique. The pre-compression parameters and post compression parameters of Solifenacin Succinate tablets were evaluated. The tablets were evaluated for in-vitro drug release studies. Based on similarity factor f2 cross povidone (1.17%), Methocel E5 premium LV (3%), Magnesium starate (1.47%), Aerosil (0.529%) was selected.

Formulation Development and Evaluation of Mouth Dissolving Tablet of Anti-allergic Drug (Astemizole)

Mouth dissolving tablets are those that dissolve or disintegrate quickly in the oral cavity, resulting in solution or suspension. In the present study Mouth dissolving tablet of Astemizole was prepared by direct compression method using crosspovidone, Crosscarmellose and Indion 414, as superdisintegrants. Tablet was formulated by using different super disintegrants such as Crosscarmellose, Crosspovidone and Indion 414 in the ratio of 6%, 9% and 12% as represented by F1 to F9 respectively. The tablets prepared were evaluated for various parameters like various density parameters, thickness, hardness, friability, disintegration time, wetting time and In-vitro dissolution time. All the parameters were found to be within limits. The developed formulation of Astemizole batch F8 (9% Indion 414) showed good palatability and dispersed within 30 seconds as compared to crosscarmellose. In vitro dissolution study of Different Formulation with 9% crosscarmellose sodium, crosspovidone and Indion 414 showed maximum dissolution rates with 81.32%, 85.3% and 95.48% respectively of the drug released in 4 minutes. The best fitted model for the optimized formulation of F8 batch was found to be higuchi model. Higuchi model show the maximum release of drug having R value 0.996.