Cross Carmellose Sodium Research Articles

Formulation and Optimization of Fast Dissolving Tablets of Zidovudine.

Fast-dissolving tablets (FDTs) have emerged as a prominent alternative to conventional oral dosage forms, particularly for drugs requiring rapid onset of action. This study aims to formulate and optimize fast-dissolving tablets of zidovudine, an antiretroviral medication used in the treatment of HIV/AIDS. The primary objective was to enhance patient compliance by ensuring the tablet disintegrates and dissolves quickly in the oral cavity without the need for water. Using various superdisintegrants like sodium starch glycolate and cross-carmellose sodium into, multiple formulations were prepared. The optimized formulation was evaluated based on pre-compression and post-compression parameters, including hardness, friability, disintegration time, dissolution profile, and drug content uniformity. The study found that the incorporation of superdisintegrants significantly improved the dissolution rate of zidovudine, thus offering a promising approach for patients with swallowing difficulties and ensuring better therapeutic efficacy.

OPTIMIZATION AND CHARACTERIZATION OF FAST DISSOLVING TABLETS OF CANDESARTAN CILEXETIL PREPARED FROM SPHERICAL AGGLOMERATES

The primary objective of this study was to develop a rapidly dissolving tablet containing an antihypertensive drug, candesartan cilexetil (CAND). The research work focused on improving solubility and in vitro dissolution of drugs using spherical agglomeration technique. Spherical agglomerates of CAND were developed using PVPK-30 as polymer and dichloromethane as bridging liquid. A spherical agglomerate of CAND was used to formulate fast dissolving tablet (FDT) with different superdisintegrants like Crospovidone and Cross carmellose sodium. The prepared powder blend was evaluated for different pre-compression parameters like solubility, compressibility index, Hausner’s ratio and flow property and post-compression parameters including in vitro dissolution study. The solubility of prepared agglomerates was found to be 0.15 to 0.91 mg mL-1, and it was higher than the pure drug (0.00071 mg mL-1). In vitro drug release study of optimized batch of FDT has shown 95.47 % of drug release. From the results, it was revealed that the prepared FDT using the agglomeration technique might be used to enhance the solubility and bioavailability of CAND to augment acute and chronic hypertension therapy.

Formulation and Drug Release Study of Rivaroxaban Oral Disintegrating Tablets Using Various Super-Disintegrants

This study aims to improve Rivaroxaban's solubility, dissolution, and bioavailability. Orally disintegrating tablets (ODTs) made with super-disintegrants like crospovidone, sodium starch glycolate, and cross-carmellose sodium will do this. Tablet preparation used direct compression and formulation optimization with design expert software. After a thorough factorial design and evaluation of pre- and post-compression parameters, the F3 batch, which contained Rivaroxaban (7.97%), Crospovidone (3.59%), Croscarmellose sodium (5.18%), Sodium Starch Glycolate (5.18%), Lactose Anhydrous (31.08%), Mannitol (15.94%), MCC (27.89%), SSF (1.59%), and Talc (1.59%), was the best. The enhanced tablet formulation (F3) showed positive qualities, including 3.3 kg/cm² hardness, 23 seconds disintegration time, and 99% drug release after 30 minutes. The innovative Rivaroxaban orally disintegrating tablet (ODT) method disintegrated and dissolved faster than market forms. Rivaroxaban's physical and chemical properties were assessed before formulation. The medication was colorless, scentless, crystalline, and melted at 227°C-229°C, as described in published research. The pharmaceutical was found to be a BCS Class II drug with low water solubility and high solubility in acetate buffer pH 4.5 and 0.1 N Hydrochloric acid. Fourier-transform infrared spectroscopy (FTIR) confirmed no drug-polymer-excipient interactions. Every batch of tablets exhibited uniform thickness (3.5 mm to 3.8 mm) and diameter (10.31 mm to 10.36 mm), indicating good compression without adhering to shaping tools. All samples had a 3-5 kg cm-² hardness, indicating strong mechanical properties. The Roche friability method showed that all batches had good abrasion resistance, ranging from 0.1% to 0.5%. Variations in croscarmellose sodium and crospovidone on tablet disintegration time and hardness were examined using design expert software. The ANOVA showed important factors affecting these attributes. Data-driven polynomial equations predict tablet disintegration time and hardness. These models reveal formulation parameters that affect tablet performance. Thus, the improved F3 batch of rivaroxaban orally disintegrating tablets (ODTs) improves solubility, dissolving, and bioavailability. This may improve treatment outcomes.

Formulation and Evaluation of Mouth Dissolving Tablet of Biperiden HCL for Treatments of Parkinson’s Disease

Seven formulations were developed using superdisintegrating substances like sodium starch glycolate, crospovidone, and cross-carmellose sodium at different concentrations. Three batches were created by employing varying concentrations of the super disintegration approach, utilizing sodium starch glycolate as the superdisintegrating agent. The batches underwent evaluation regarding sensory characteristics, firmness, breakability, weight consistency, disintegration time in a simulated environment, time is taken for wetting, laboratory tests on drug release within a controlled environment, and assessments of product stability. Fourier transform infrared spectroscopy (FTIR) studies confirmed the absence of drug-excipient interactions. In this examination, mouth-dissolve tablets of biperiden HCL were successfully ready with favorable parameters, including organoleptic properties, hardness (3.2 kg/cm3), friability (0.23%), weight variation (100 mg), disintegration time within a controlled laboratory environment (17 seconds), wetting time (11 seconds), and in-vitro drug release studies (99.80%). The study concluded that the biperiden hydrochloride mouth-dissolving tablet was effectively formulated using the direct compression method, demonstrating improved patient compliance.

FORMULATION AND EVALUATION OF ORODISPERSIBLE TABLETS OF ACECLOFENAC BY DIRECT COMPRESSION METHOD

Nowadays, Oro dispersible tablets are gaining much importance because it is easily approachable and due to its patient compliance. In this study, Formulation and evaluation of one such tablets of Aceclofenac by direct compression method using super disintegrants like Cross carmellose sodium (CCS) was performed.
 Due to low water soluble property of aceclofenac, it has poor dissolution and bioavailability. In order to minimize this property OTD’s are prepared. ODT’s were prepared by direct compression method using super disintegrant i.e Cross Carmellose Sodium (CCS) in different concentrations. The prepared powder blend was subjected to various evaluation studies like pre compression parameters like angle of repose, tapped density, and bulk density. Post compression parameters like weight variation, hardness, friability, drug content, wetting time, disintegration and dissolution studies were performed. The drug excipients compatibility was verified by FTIR.
 The precompression evaluation studies showed that the prepared powder blend has good flow property. The hardness and friability revealed that it has good mechanical strength with acceptable disintegration time. The optimized formulation indicated good in vitro drug dissolution profile with maximum drug being released at all the time intervals indicates an ideal profile for the development of ODT’s. The results of pre compression studies and post compression along with FTIR are presented.

Formulation and Assessment of Quick dissolving tablet of Candesartan cilexetil arranged from their circular agglomerates

Candesartan cilexetil is water insoluble drug which comes under BCS class second category. Drug was used in the treatment of acute and chronic hypertension. The research workgenerally focuses on the solubility enhancement, increasing dissolution behavior, flowability and compressibility of the drug. Tablets and capsule are the solid dosage form mostly used. Spherical agglomerates of Candesartan cilexetil were prepared. Candesartan cilexetil water insoluble drug was used. With the incorporation of polymer, Agglomerates of such drug was prepared. Fast dissolving tablet was prepared and evaluated. Evaluation parameter like FTIR, DSC was carried out. Precompression parameters like bulk density, tap density, angle of repose, compressibility index was carried out. Post compression parameters like friability, hardness, thickness, disintegration time, wetting time was carried out and evaluated. Effect of different disintegrant like Crospovidone, cross carmellose sodium was studied. From in vitro study it was found that cross carmellose sodium containing batch F3 shows better drug release so it shows enhanced dissolution rate while if cross carmellose sodium level increases thus decreasing their dissolution rate.

Optimization of diluents on the basis of SeDeM-ODT expert system for formulation development of ODTs of glimepiride

The present study aimed to optimize diluents characteristics (rheological characteristics, compressibility and disintegration behavior) using SeDeM-ODT expert system, to mask poor characteristics of APIs and will help in development of a formulation which is to be processed by direct compression technique. On the basis of SeDeM-ODT experts system, various parameters were determined for glimepiride, diluents and other excipients, and evaluated their suitability for direct compression and bucco-dispersibility. Diluents were selected and powder blend of all the developed formulations were tested as per SeDeM-ODT expert system. Powder blends were compressed to ODTs and cross carmellose sodium was used as super dissintegrant. Different parameters of the powder blend related to flow were evaluated while compressed tablets were subjected to various official and un-official quality control tests. SeDeM-ODT Experts system was successfully applied for optimization of diluents and all the formulations exhibited better flow, disintegration behavior and sufficient mechanical strength, irrespective of the addition of other excipients having poor characteristics. Results of the developed formulations was same as predicted in terms of rapid disintegration (disintegration < 60sec) and high mechanical strength (crushing strength greater than 40 N) of the tablets. SeDeM-ODT expert system can help in selection of diluents with optimum characteristics, required for tablet preparation by direct compression, facilitating the process of formulation development and avoided extensive experimentation, as carried out in conventional statistical optimization.

The effect of biomaterials of cross carmellose sodium and Eudragit S-100 as model polymers on colon targeted drug release in different dosage forms

The aim of this study to find out the role of biomaterial cross carmellose sodium and Eudragit s100 is to control the drug release drug dosage form into a particular site, colon, which is part of large intestine. The drug Budesonide was used as a model drug. In this study nine formulations (F1-F9) were prepared using different concentration of polymer, cross carmellose Sodium and all were evaluated as per standard parameters, and found as per prescribed standards. All formulation were pursued for coating process using Eudragit S100 as a polymer and different excipients like castor oil act as a plasticizer, talc as anti-agglomerative agent. All the formulation showed significant role in gastric media, i.e. 0.1 NHCl does not release the drug in in GI fluids for 2 h. Most of the formulation has given their release above 90% but F4 has given its release 99.4 in 36 h in colon part of large intestine. It shows a sustained and constant release performance till next 36 h which showing the best release among all formulation.

FORMULATION AND EVALUATION OF PIROXICAM FAST DISSOLVING TABLETS

Piroxicam is an analgesic, antipyretic and anti-inflammatory effects drugs, used to reduce pain, swelling joint stiffness from osteoarthritis, rheumatoid arthritis and by inhibiting prostaglandin synthetase. In the research work, seven formulations (F1 to F7) were prepared direct compression method by using 3 superdisintegrants namely Crospovidone, Crosscarmellose sodium and Sodium starch glycolate in two ratio (1:0.5 and 1:1) and F7 (without superdisintegrant). All the formulations evaluated various post compression parameters thickness, weight variation, disintegration time, hardness, friability, wetting time, drug content water absorption ratio and in- vitro dissolution studies. The best formulation was studied anti-inflammatory activity in rats by using the paw-edema method. Among all formulations (F1) which contains 1:0.5ratio of Croscarmellose sodium, showed to be the optimized formulation as it give good wetting time (51.66 sec), fast disintegration time (29.16 sec), maximum drug release of 99% within 30 minutes and superior anti-inflammatory activity.

FORMULATION AND EVALUATION OF FAST DISSOLVING TABLETS OF LANSOPRAZOLE BY SOLUBILITY ENHANCEMENT TECHNIQUE

The present study was focused on preparation and evaluation of Lanzoprazole fast dissolving tablets. Lansoprazole (LAN) is a proton pump inhibitor drug and used for the treatment of gastric ulcer. Lansoprazole is acid labile drug and to avoid the acidic pH of the stomach LAN is formulated as oral fast dissolving tablets. Lansoprazole is the class II drug of the BCS classification and has a low aqueous solubility. Hence, to improve the solubility of the drug we have prepared Lansoprazole solid dispersion with poly ethylene glycol and complex with β cyclodextrin. Fast Dissolving tablets of LAN were formulated using different superdisintegrants like Sodium Starch Glycolate, Cross Povidone, Cross Carmellose Sodium by direct compression method. The prepared fast dissolving tablets were evaluated for various parameters like weight variation, hardness, friability, disintegration time, drug content, wetting time, in-vitro drug release and short term stability studies. Percentage weight variation, hardness, friability and drug content uniformity were found to be within the approved range for all the formulations. The in-vitro release studies showed that 99.6% of LAN within 90 sec. Overall, in the formulations prepared by the direct compression method, F3, which contains 6% CCS as super disintegrants release 99% of (LAN) in 2 min was found to be the best formulation. The results concluded that fast dissolving tablets of LAN showing enhanced dissolution might lead to improved bioavailability and effective therapy for gastric ulcer. KEYWORDS: β cyclodextrin, Cross Povidone, Fast dissolving tablets, Gastric ulcer, Lanzoprazole, Solid dispersion

FORMULATION DEVELOPMENT AND EVALUATION OF CHRONOMODULATED DRUG DELIVERY SYSTEM BY ZAFIRLUKAST

Objective: The main objective of the present study was to formulate and evaluate a time-controlled single-unit oral pulsatile drug delivery system containing Zafirlukast for the prevention of nocturnal asthma attacks. To provide time-scheduled drug release for Asthma disease. It is used for preventing asthmatic attacks at early morning. Pulsatile release dosage form is increasing patient compliance by reducing the dosing frequency, especially in the early morning.&#x0D; Methods: Core tablets were prepared by incorporating different concentrations of natural and synthetic super disintegrants. Drug-containing core tablets (ZC1-ZC15) with different compositions of natural super disintegrants (Plantago ovata seed powder, Locust bean gum) synthetic super disintegrants (Sodium starch glycolate (SSG), Cross carmellose sodium (CCS), Crospovidone (CP)) were prepared by direct compression technique. The core tablets were subjected to pre-formulation, physicochemical and In vitro drug release studies. The fast disintegrating core tablet formulation was selected and press-coated tablets (P1-P11) were prepared with different compositions of hydrophobic polymers Eudragit RS100, Eudragit RL 100, Ethylcellulose and hydrophilic polymers Hydroxypropyl methylcellulose K4M, K100M. The optimized formulation was selected and quantified based on in vitro drug release profile in simulated gastric and intestinal fluids.&#x0D; Results: The pre and post-compression parameters of tablets were also found to be within limits. Formulation ZC5 with 16 mg of Locust bean gum showed the least disintegrating time, i.e., 22.13 sec, and was selected as the best immediate release core tablet. The press-coated tablet formulation P8 having 62.5 mg Eudragit RS100 and 62.5 mg of HPMC K4M in ratio 1:1 over the core tablet ZC5 showed rapid and drug release nearly after 4 h lag time and 98.86 % up to 12 h. Accelerated stability studies of the optimized formulation P8 indicated no significant difference in release profile after 3 mo.&#x0D; Conclusion: The in vitro dissolution study showed that lag time before drug release was highly affected by the coating amount level and nature of coating polymer used. Time-controlled pulsatile release tablets can be prepared using press-coating techniques.

Formulation Development and Evaluation of Mouth Dissolving Tablet of Aspirin by Using QbD Approach

In the current investigations, mouth dissolving tablets (MDT) were developed by applying quality by design (QbD) approach. Direct compression method was applied for the preparation of MDT containing aspirin using 32 factorial design with quantity of drug, microcrystalline cellulose (MCC) and crosscarmellose sodium (CCS) as dependant variables. MCC and CCS were used as superdisintegrants. Sodium stearyl fumarate was used as lubricant. Developed MDT were evaluated for characteristics like hardness, friability, disintegration time (DT) and in vitro drug release . Design Expert 11.0 described adequately impact of selected variables (MCC and CCS) at various levels for response under study (DT and friability). The optimized batch showed disintegration time of 15-28 secs, friability within 1% and in vitro drug release of 75-98% after 30 mins, respectively. The present study of experimental design revealed that MCC and CCS are fruitful at low concentration to develop the optimized formulation. As per the results obtained from the experiments, it can be concluded that QbD is an effective and efficient approach for the development of quality into MDT with the application of QTPP, risk assessment and critical quality attributes (CQA).&#x0D; Dhaka Univ. J. Pharm. Sci. 20(1): 19-29, 2021 (June)

Production and Evaluation of Disintegrant Properties of Microcrystalline Cellulose Derived from SaccharumofficinarumL (Poaceae) in Metronidazole Based Formulation

The aim of the study was to produce microcrystalline cellulose from Saccharumofficinarum and to evaluate its use as a disintegrant in metronidazole tablet formulation. Cellulose was produced and characterized. This was followed by a comparative characterization of the tablets formulated by using Saccharumofficinarummicrocrystalline cellulose (SO-MCC), maize starch and crosscarmellose sodium (Ac-di-sol®) as disintegrants. The granules were evaluated for flow properties and the tablet evaluated for hardness, friability, disintegration and dissolution properties. For disintegration studies, the disintegrants disintegrated within 10 minutes in this order: Ac-di-sol® &gt;SO-MCC&gt;Maize starch. All the tablets exhibited high release profile which conformed to British Pharmacopoeia standards. Hence, SO-MCC can be used as an alternative disintegrant in terms of cost and availability.

A REVIEW ON FAST DISSOLVING TABLETS

A REVIEW ON FAST DISSOLVING TABLETS Jyoti Saxena*, Digvijay Singh, Amrita Bisht, Arvind Negi, Aman Verma GRD Institution of Management & Technology (Pharmacy), Dehradun, Uttarakhand, India ABSTRACT As we are aware of the fact that Fast dissolving tablets have made an appearance as one of the most greatly welcomed dosage form, exceptionally between the pediatric patients and also among the geriatric patients, as both the category of patients have weaker muscular and the nervous system in comparison to adults as well as struggle to consume tablets and capsules. In the case of geriatric patients, Parkinson’s disorder and hand tremors are a major concern and Fast dissolving tablet is one of the most convenient dosage forms. The oral route is considered one of the best-preferred route to administer the drug in animal body but it also has few limitations too. For example, drugs have to go through first-pass metabolism, not preferred in psychiatric and bedridden patients. The FDTs are structured in a way to dissolve very quickly in saliva and this is the most celebrated property of FDTs, that these tablets disintegrate or dissolve in saliva in less than a minute and this process does not need water. Superdisintegrants like Crosscarmellose Sodium and Sodium Starch Glycolate are the backbones of the FDTs, which amplify the rate of disintegration of tablets inside the buccal cavity, results in faster absorption and finally improved bioavailability. There are a number of advantages are offered by FDTs which includes trouble-free transportation and manufacturing, error-free dose, remarkable physical and chemical stability, and above all, its acceptance among pediatrics and geriatric patients. FDTs provide the benefits of both the conventional tablets as well as of liquid dosage forms. FDTs can be manufactured by a number of conventional and patented technologies such as melt granulation, sublimation, direct compression freeze-drying or lyophilization, cotton candy process, etc. These techniques yield the rapid disintegration of tablets which dissolve in the buccal cavity in five seconds and do not need water and chewing. This review includes the definition, needs, advantages, and limitations, challenges to formulate and to manufacture the FDTs, and also some formulations of fast dissolving tablets which are available in market. Keywords: Fast Dissolving Tablet, drug delivery system, rapid disintegrating, fast melting Full Text Article

DEVELOPMENT AND CHARACTERIZATION OF ORAL SWELLABLE RAPID RELEASE FILM WITH SUPERDISINTEGRANT-SURFACTANT

Objective: Oral disintegrating films consisting of hydrophilic polymer are designed to be quickly hydrated by saliva, adhere to the mucosa and disintegrate rapidly to release the drug. The aim of the present study was to prepare stable, flexible swellable rapid release oral films with hydroxypropyl methylcellulose E15 LV (HPMC) and polyvinyl alcohol (PVA) in different ratios. Guar gum was incorporated as the mucoadhesive agent. In order to achieve rapid disintegration of the film cross carmellose sodium (superdisintegrant) and surfactant like Tween 80 were added. The model drug used in the study was diclofenac sodium.&#x0D; Methods: Films were developed using HPMC E15 LV and PVA by solvent casting method and characterized for thickness, swelling index, disintegration time, folding endurance, drug content, and in vitro drug release pattern and kinetics.&#x0D; Results: The prepared swellable rapid release oral films were quite flexible and transparent with a smooth texture. The swelling index study confirmed that the films possessed the desired swelling property. Fastest disintegration was observed with the oral film containing HPMC: PVA in the ratio of 2:1, guar gum at 120 mg, 20% w/w crosscarmellose sodium and 4%w/w Tween 80. The swellable rapid release oral films were found to follow either Higuchi or Korsmeyer-Peppas model with drug release following either Fickian or non-Fickian diffusion. Maximum drug release of around 70% was observed from the above-mentioned film in 1hr in simulated salivary fluid.&#x0D; Conclusion: Therefore, swellable rapid release oral films with HPMC E15 LV: PVA, guar gum, croscarmellose sodium and Tween 80 demonstrated satisfactory swelling, rapid disintegration and improved drug release for oromucosal absorption.

DEVELOPMENT AND CHARACTERIZATION OF ORODISPERSIBLE TABLETS OF PROPRANOLOL HYDROCHLORIDE USING CALCIUM CROSS-LINKED CASSIA FISTULA GUM AND CROSS CARMELLOSE SODIUM

Objective: The present investigation was aimed towards developing calcium crosslinked derivative of carboxymethylated cassia fistula gum and crosscarmellose sodium based orodispersible tablets (ODTs) of propranolol hydrochloride for enhancing the bioavailability and efficacy.&#x0D; Methods: Orodispersible tablets (ODTs) of propranolol hydrochloride was formulated using natural (a carboxymethylated derivative of cassia fistula gum) and synthetic polymer (crosscarmellose sodium) by wet and dry granulation, lyophilization and cotton candy methods and then finally compressed by direct compression. The prepared ODTs were evaluated for several parameters such as hardness, friability, in vitro disintegration time, in vitro drug release. In vivo and stability studies were carried out on optimized formulation coding PC1.&#x0D; Results: Drug polymer interaction were judged by FT-IR, DSC and XRD. The optimized formulation coding PC1 prepared by cotton candy process containing 2.5% w/w of crosslinked cassia fistula gum has the least disintegration time (18.9±0.4s), weeting time (12.5±0.8s) and relased the drug of 88.2% within 10 min in contrast to croscarmellose sodium. In vivo absorption studies revealed that same formulation has Cmax (µg/ml) 2.13±0.73, tmax (h) 0.21±0.17 and (µg ml-1 h-1) 14.33±1.59.&#x0D; Conclusion: This research manuscript clearly shows the successful development of the ODTs loaded with an antihypertensive drug, namely propranolol hydrochloride. The formulation developed by cotton candy process utilizing crosslinked cassia fistula gum as a natural superdisintegrant in contrast to other existing techniques can be a best option over synthetic superdisintegrant i.e. crosscarmellose sodium. The prepared ODTs was enhanced the absorption rate by lowering tmax, which inturn enhance the bioavailability and the efficacy of drug.

Optimization and Quality by Design Approach for Piroxicam Fast Dissolving Tablet Formulations Using Box-Behnken Design

Background: The present study deals with the formulation and optimization of piroxicam fast dissolving tablets and analyzes the impact of an independent variable while selecting the optimized formulation utilizing Quality by Design (QbD) and Box-Behnken Design (BBD). Methods: Seventeen formulations were prepared by direct compression technique by altering the proportion of cross carmellose sodium, spray dried lactose and hydro propyl methyl cellulose (HPMC K4M). The BBD statistical technique was used to optimize formulations and correlate the relationship among all the variables. Also, the powder mixture characteristics and tablet physiochemical properties such as hardness, friability, drug content, Disintegration Time (DT) and dissolution test were determined using 900 ml of 0.1N HCl (pH-1.2) at 37 ± 0.5°C. Results: Significant quadratic model and second order polynomial equations were established using BBD. To find out the relationship between variables and responses, 3D response surface and 2D contour plot was plotted. A perturbation graph was also plotted to identify the deviation of the variables from the mean point. An optimized formula was prepared based on the predicted response and the resulting responses were observed to be close with the predicted value. Conclusion: The optimized formulation with the desired parameter and formulation with variables and responses can be obtained by BBD and could be used in the large experiment with the involvement of a large number of variables and responses.

An investigation into the use of low quantities of functional additives to control drug release from hot melt extruded solid dispersions for poorly soluble drug delivery

The motivation of this study is to demonstrate the practicality of producing slow release and fast release products in a single-step hot melt extrusion (HME) process. HPMCAS as the carrier material showed good potential in monolithic controlled release formulations for the model drug, carbamazepine (CBZ). As binary formulations, CBZ-HPMCAS extrudates showed zero-order release over 24 h which was accompanied by the swelling of the extrudates. A range of functional excipients was used at low quantities to modulate the release rate. The release rates of the HME extrudates could be either accelerated by the incorporations of low quantities (5% w/w) of soluble additives or further sustained by adding lipid excipient, Gelucire 50/13. Clear phase separations of the soluble additives including crosscarmellose sodium, sodium starch glycolate, maltodextrin and lactose in the extrudates led to higher interior porosity and quicker erosion in comparison to the binary extrudates. The phase separated Gelucire in the extrudates led to the substantial swelling of the extrudates and resulted in further prolonged drug release. This study provided clear formulation strategies for modulating the drug release rate from controlled release formulation prepared directly by single-step HME. In addition, this research work also evaluates for the first time HME extrudates simultaneous swelling and drug release using this UV imaging technique. The whole dose cell of this instrumentation is utilised to provide insights into the dissolution process of solid dispersions prepared by HME.

Formulation and Evaluation of Rapimelt Tablet of Anti-Vertigo Drug (Lorazepam)

A. Rapimelt tablet of Lorazepam was prepared by direct compression method using Indion 414, Cross Carmellose Sodium and sodium starch glycolate as superdisintegrants with aim to get rapid onset of action, improve bioavailability and to give pleasant taste and better mouth feel. The tablets prepared were evaluated for various parameters like various density parameters, thickness, hardness, friability, disintegration time, wetting time and invitro dissolution time and were found to be within limits as per Indian Pharmacopoeia. FT-IR spectra of physical mixture of Lorazepam with Indion 414showedretention of basic peaks of Lorazepam. The developed formulation of Lorazepam batch F5 (10% Indion 414) showed good palatability and dispersed within 30 seconds as compared to Crosscarmellose Sodium batches F1-F3 and Sodium starch glycolate batches F6-F9.

Formulation and Evaluation of Immediate Release Tablet of Simvastatin

Simvastatin is an Antilipidemic agent. The aim is to formulate and evaluate immediate release Simvastatin tablets prepared by wet granulation method. Sodium starch glycolate and crosscarmellose sodium were used as superdisintegrants. Formulations were prepared by Simvastatin with different concentration (1%, 2% and 3%) of crosscarmellose sodium and sodium starch glycolate. Formulations were evaluated for different pre and post compression parameter and in vitro drug release studies. The FTIR studies showed that there is no interaction between the drug and polymer. The results of pre compression parameters of batch I1 to I6 were compared with prescribed limits. It showed that batch I1 to I6 powder blend exhibit good flow property and compressibility property. In formulation I1-I6, disintegration time was observed 3–8 min and 100% drug released within 10–60 min time interval. Thus, based on evaluation of different parameters it was concluded that formulation of immediate release tablets of Simvastatin was successfully done and I2 showed almost 100% drug release at 10 min.