Orally Disintegrating Tablets

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Orally disintegrating tablets: A Review

Orally disintegrating tablets: A Review

O ral dosage forms like tablets and capsules possessing great problem of swallowing mainly for pediatrics, geriatrics, and bedridden, nauseous or non-compliant patients‟. Orally disintegrating dosage forms has to be placed in mouth and then get dispersed in saliva without the need of water 3,4 . Orally disintegrating tablets are also called as oral disperse, mouth dissolving, rapidly disintegrating, fast melt, and quick dissolve system. From past decade, there has been an increased demand for more patient-friendly and compliant dosage forms. As a result, the demand for developing new technologies has been increasing day by day 5 . US Food and Drug Administration Center for Drug Evaluation and Research (CDER) defines, in the „Orange Book‟an ODT as “a solid dosage form containing medicinal substances, which disintegrates rapidly, usually with a matter of seconds, when placed upon the tongue” 6 . United States Food and Drug Administration (FDA) define orally disintegrating tablets as “A solid dosage form which contain a medicinal substance or active ingredient which disintegrates rapidly within a matter of seconds when placed upon a tongue” 7 . European Pharmacopoeia described orally disintegrating tablets as „uncoated tablets intended the placed in the mouth where they disperse rapidly before being swallowed‟ and as tablets which should disintegrate within 3 min 8 .
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 ORALLY DISINTEGRATING TABLETS: A REVIEWsfsf

 ORALLY DISINTEGRATING TABLETS: A REVIEWsfsf

ABSTRACT Orally disintegrating tablets (ODTs) are gaining prominence as new drug delivery systems and emerged as one of the popular and widely accepted dosage forms, especially for the pediatric and geriatric patients. To obviate the problem of dysphagia and to improve patient compliance, ODTs have gained considerable attention as preferred alternatives to conventional tablet and capsule formulations. Various scientific techniques including freeze drying, moulding, spray drying, sublimation, direct compression, cotton candy process, mass extrusion, melt granulation etc. have been employed for the development of ODTs. These techniques render the disintegration of tablet rapidly and dissolve in mouth without chewing or additional water intake. The current article is focused on ideal characteristics, significant features, patented technologies, formulation aspects including the use of superdisintegrants. Various marketed preparations along with numerous scientific advancements made so far in this avenue have also been discussed.
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Orally Disintegrating Tablets: A Review

Orally Disintegrating Tablets: A Review

Jaysukh J Hirani 1* , Dhaval A Rathod 1 , Kantilal R Vadalia 2 1 Smt. R.D.Gardi B. Pharmacy College, Rajkot-360110, 2 Shri H.N.Shukla College of Pharmacy, Rajkot, Gujarat, India. Abstract Drug delivery systems are becoming increasingly sophisticated as pharmaceutical scientists acquire a better understanding of the physicochemical and biochemical parameters pertinent to their performance. Over the past three decades, orally disintegrating tablets (ODTs) have gained considerable attention as a preferred alternative to conventional tablets and capsules due to better patient compliance. ODTs are solid dosage forms containing medicinal substances which disintegrate rapidly, usually in a matter of seconds, when placed on the tongue. Products of ODT technologies entered the market in the 1980s, have grown steadily in demand, and their product pipelines are rapidly expanding. New ODT technologies address many pharmaceutical and patient needs, ranging from enhanced life-cycle management to convenient dosing for paediatric, geriatric, and psychiatric patients with dysphagia. This has encouraged both academia and industry to generate new orally disintegrating formulations and technological approaches in this field. The aim of this article is to review the development of ODTs, challenges in formulation, new ODT technologies and evaluation methodologies, suitability of drug candidates, and future prospects.
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FORMULATION AND EVALUATION OF ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS

FORMULATION AND EVALUATION OF ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS

INTRODUCTION The oral route is considered as the most widely accepted route for drug administration because of its convenience of self administration and easy manufacturing. [1,2] But the drawback of the oral dosage forms like tablets and capsules is difficulty in swallowing, leading to patient‟s incompliance particularly in case of pediatric and geriatrics. [1] It also applies to people who are ill in bed and to those active working patients who are busy or traveling and those who have no access to water. [2] Orally disintegrating tablets can also called as fast dissolving tablets, orodispersible tablets, mouth dissolving tablets, fast disintegrating tablets, porous tablets, quick disintegrating tablets, rapid dissolving tablets, and rapimelts. ODTs dissolve / disintegrate in the mouth in matter of seconds without water. Fast disintegration of tablets leads to quick dissolution and rapid absorption which may produce rapid onset of action. Excellent mouths feel property can be produced by use of flavors and sweeteners help to change the perception of “medication as bitter pill” especially in pediatric population. ODTs have all the advantages of solid dosage forms and liquid dosage forms.
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SUPERDISINTEGRANTS IN THE DEVELOPMENT OF ORALLY DISINTEGRATING TABLETS: A REVIEW

SUPERDISINTEGRANTS IN THE DEVELOPMENT OF ORALLY DISINTEGRATING TABLETS: A REVIEW

Institute of Pharmaceutical Sciences, Kurukshetra University, Kurukshetra, Haryana, India ABSTRACT The desire of improved palatability in orally administered products has prompted the development of numerous formulations with improved performance and acceptability. Orally disintegrating tablets are an emerging trend in novel drug delivery system and have received ever-increasing demand during the last few decades. The field has become a rapidly growing area in the pharmaceutical industry and gaining popularity due to ease of administration and better patient compliance especially for geriatric and pediatric patients. ODTs are solid unit dosage forms, which disintegrates or dissolves rapidly in the mouth without chewing and water. This type of property in dosage form can be attained by addition of different excipients, from which disintegrant is the key adjuvant. In recent years, several newer agents have been developed known as superdisintegrants. Diverse categories of superdisintegrants such as synthetic, semi-synthetic, natural and co- processed blends etc. have been employed to develop effectual mouth dissolving tablets and to overcome the limitations of conventional tablet dosage forms. The objective of the present article is to highlight the various kinds of superdisintegrants along with their role in tablet disintegration and drug release, which are being used in the formulation to provide the safer, effective drug delivery with patient compliance. This review focuses on various synthetic superdisintegrants, natural superdisintegrants from different plant sources, co-processed excipients blend and their efficiency.
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Formulation and Evaluation of Orally Disintegrating Tablets of Ondansetron Hydrochloride

Formulation and Evaluation of Orally Disintegrating Tablets of Ondansetron Hydrochloride

Nitin Bansal et al., (2011) 44 developed orally disintegrating tablets of Ondansetron HCl by dry granulation method using different concentrations of superdisintegrants such as modified gum karaya, modified natural agar, croscarmellose sodium and sodium starch glycollate. The formulations were evaluated for weight variation, hardness, friability, drug content, wetting time, in vitro disintegration time and in vitro dissolution study. The results showed that modified gum karaya and modified natural agar produce rapid disintegration of tablets. The optimized formulation showed acceptable physical characteristics and produced complete drug release within 6 minutes. The incorporation of clove oil provided additional properties such as symptomatic relief from nausea and vomiting, good mouth feel and taste masking.
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FORMULAION AND EVALUATION OF ORALLY DISINTEGRATING TABLETS OF RIZATRIPTAN BENZOATE REVIEW

FORMULAION AND EVALUATION OF ORALLY DISINTEGRATING TABLETS OF RIZATRIPTAN BENZOATE REVIEW

Figure 4 : Cumulative drug releases of all formulations CONCLUSION The goal of the present investigation was to identify the optimum combination of superdisintegrants for the development of orally disintegrating tablets of Rizatriptan benzoate. Three superdisintegrants viz., crospovidone, croscarmellose sodium and sodium starch glycolate were tried. 2 2 full factorial design was used for a set of two superdisintegrants and totally twelve formulations were made by direct compression method and evaluated for their hardness, friability and the key parameters like INVITRO dispersion time, wetting time and water absortion ratio. Factorial design had facilitated the study and helped in understanding the interaction between superdisintegrants when used in combinations. 3%croscarmellose sodium and 8% sodium starch glyocolate (F12) was identified as the optimum combination of super disintegrants based on INVITRO dispersion time, wetting time and water absorption ratio.
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FORMULATION AND EVALUATION OF CLONAZEPAM ORALLY DISINTEGRATING TABLETS, 1 MG

FORMULATION AND EVALUATION OF CLONAZEPAM ORALLY DISINTEGRATING TABLETS, 1 MG

NOVELTY Clonazepam is a poorly soluble drug. Based on the literature information, Dry granulation / hot melt extrusion granulation / solid dispersion by fusion or solvent evaporation / ion- exchange complexation / direct compression process will not be explored. No non-aqueous solvent will be used. To achieve good organoleptics, effective solubilisation and good content uniformity wet granulation process using Sodium Lauryl Sulphate in Water will be done for manufacturing the Clonazepam Orally Disintegrating Tablets, 1 mg. The formulation will be fully optimized with respect to composition and process to ensure good blend flow, tableting, organoleptics and stability. The finalized drug product will be evaluated for comparable dissolution profile and bioequivalence against the internationally marketed product.
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IN VITRO AND IN VIVO EVALUATION OF ACECLOFENAC LYOPHILIZED ORALLY DISINTEGRATING TABLETS

IN VITRO AND IN VIVO EVALUATION OF ACECLOFENAC LYOPHILIZED ORALLY DISINTEGRATING TABLETS

while insignificant difference regarding Mean residence time (MRT) (p > 0.05). The relative bioavailability of the Aceclofenac ODT (LA# 10) was 186.12% relative to the IR tablet (Bristaflam ® ) taken as reference standard. INTRODUCTION: Orally disintegrating tablets (ODTs) offer an advantage for populations who have difficulty in swallowing (Dysphagia). Dysphagia is common among all age groups and more specific with pediatric, geriatric population along with institutionalized patients and patients with nausea, vomiting, and motion sickness complications 1, 2 . ODTs with good taste and flavor increase the acceptability of bitter drugs by various groups of population. ODT is a single unit dosage form that disintegrates in the oral cavity rapidly, usually in few seconds to enhance compliance
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PREPARATION AND CHARACTERIZATION OF ATENOLOL β CYCLODEXTRIN ORALLY DISINTEGRATING TABLETS

PREPARATION AND CHARACTERIZATION OF ATENOLOL β CYCLODEXTRIN ORALLY DISINTEGRATING TABLETS

Karina Citra Rani * , Nani Parfati and Stephanie Department of Pharmaceutics, Faculty of Pharmacy, University of Surabaya, Surabaya, East Java, 60293, Indonesia. ABSTRACT: Atenolol is a hypertension drug that has a low solubility characteristic in water and gastric fluid. The rate of absorption of the drug with poor solubility characteristics is determined by the dissolution process. In this study, an attempt has been conducted to increase the dissolution of atenolol by increasing its solubility. The solubility of atenolol has been enhanced by the inclusion complex using β- cyclodextrin made by several methods (physical mixing, kneading, and solvent evaporation). Evaluation and characterization of atenolol-β- cyclodextrin inclusion complex consist of drug content, dissolution test, Fourier Transformed Infrared analysis (FT-IR), Differential Scanning Calorimetry (DSC), X-ray Diffraction (XRD) and Scanning Electron Microscope (SEM). The results of the drug content analysis, dissolution test, and characterization showed that atenolol- β-cyclodextrin inclusion complex, which has been made by the solvent evaporation method was the best approach. Therefore, a solvent evaporation method was chosen to formulate orally disintegrating tablets of atenolol-β-cyclodextrin using direct compression technique. Orally disintegrating tablets of atenolol-β- cyclodextrin were prepared using crospovidone as disintegrant. The results of pre-compression test and the post-compression test revealed that orally disintegrating tablets of atenolol-β-cyclodextrin inclusion complex disintegrate within 8.17 ± 0.41 sec. In-vitro dispersion time in simulated saliva was found to be 45.33 ± 0.58 sec and the percentage of atenolol dissolved from this formula was 92.22% in 30 min. Hence, this formula shows good physicochemical characteristics and fulfill pharmaceutical quality requirements of orally disintegrating tablet.
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Formulation and Evaluation of Orally Disintegrating Tablets of Antihypertensive Drug Naftopidil

Formulation and Evaluation of Orally Disintegrating Tablets of Antihypertensive Drug Naftopidil

In the present work, orally disintegrating tablets of naftopidil were designed with a view to enhance patient compliance. A combination of superdisintegrants i.e sodium starch glycolate and crospovidone XL were used along with directly compressible mannitol to enhance mouth feel. The prepared batches of tablets were evaluated for hardness, weight variation test, friability, wetting time, disintegration time and In-vitro drug release studies. The prepared tablets were characterized by DSC studies. Different formulations showed disintegration time in the range of 20 to 37 sec. Among all the formulation, F7 showed 97.98% drug release within 60 minutes and considered best among the other formulations. No chemical interaction between the drug and excipients was confirmed by DSC studies. The stability study was conducted as per ICH guidelines and the formulation (F7) was found to be stable, with insignificant change in disintegration time, wetting time and in-vitro drug release pattern. The results revealed that orally disintegrating tablets of the poorly soluble drug naftopidil showed enhanced dissolution and, hence, better patient compliance.
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EVALUATION OF EFFECT OF VARIOUS SUPERDISINTEGRANTS ON DISINTEGRATION TIME OF ORALLY DISINTEGRATING TABLETS

EVALUATION OF EFFECT OF VARIOUS SUPERDISINTEGRANTS ON DISINTEGRATION TIME OF ORALLY DISINTEGRATING TABLETS

Dept. of Pharmaceutics, Vivekanand Education Society’s College of Pharmacy, Chembur, Mumbai – 400074, Maharashtra, India. ABSTRACT Superdisintegrants are used to improve the efficacy of solid dosage forms. This is achieved by decreasing the disintegration time which in turn enhances drug dissolution rate. Superdisintegrants are generally used at a low level in the solid dosage form, typically 1- 10 % by weight relative to the total weight of the dosage unit. Direct compression process was selected for this formulation of ODT tablets, because porous nature is more in direct compression blend than wet granulation blend, so it will give faster disintegration. Microcrystalline cellulose was used as diluent and mannitol and sodium saccharin were used to enhance the organoleptic properties of tablets. The objective of the study was to compare disintegration times of various commonly used superdisintegrants in orally disintegrating tablets. It was found that L-HPC would be effective in providing faster disintegration time.
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Study on the Characteristics of Zolpidem Orally Disintegrating Tablets from Different Formulations

Study on the Characteristics of Zolpidem Orally Disintegrating Tablets from Different Formulations

Conventional oral dosage forms require attention when taken by patients who find difficulty in swallowing, like the elderly, to avoid aspiration. In addition, for water deprivation patients due to disease, it is necessary to take into consideration the amount of water used when taking. To address these problems, a new dosage form known as orally disintegrating tablets (ODTs) has been developed. This dosage form consists of tablets that rapidly disintegrate and dissolve in the saliva and are thus easy to swallow without the need for water [5]. In addition, patients suffering from dysphagia, motion sickness, repeated emesis, or a mental disorder prefer ODTs since they cannot swallow large quantities of water [6]. Moreover, it is a suitable dosage form for drugs that are readily absorbed via the oral mucosa or have immediate pharmacological action. ODTs are classified into three types based on their method of formulation: Rapidly disintegrating tablets [7], molded tablets [8], and typical ODTs [9]. These three different types differ in the types of disintegrants, types of additives, and methods of manufacture, which presumably affects the tablets’ disintegration.
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FORMULATION DEVELOPMENT AND IN-VITRO EVALUATION OF ESCITALOPRAM OXALATE ORALLY DISINTEGRATING TABLETS

FORMULATION DEVELOPMENT AND IN-VITRO EVALUATION OF ESCITALOPRAM OXALATE ORALLY DISINTEGRATING TABLETS

The purpose of this research was to develop Orally disintegrating tablets of escitalopram Oxalate. Orally disintegrating tablets offers a solution for paediatrics, geriatrics; psychiatric or mentally ill people and those have difficulty in swallowing tablets/capsules resulting in improved patient compliance. Selective serotonin reuptake inhibitors (SSRIs), which are broad spectrum antidepressants that are effective for major depressive disorder and several anxiety disorders. Escitalopram Oxalate is highly selective, more effective and better than other SSRIs. The aim is to formulate Orally disintegrating tablets of escitalopram oxalate using different ratios of Superdisintegrants LHPC-21, Kyron and Crospovidone, while Microcrystalline cellulose, Mannitol, Prosolv ODT used as fillers. Tablets were prepared by direct compression method. The tablets were evaluated for hardness, thickness, friability, and weight variation and disintegration time, dispersion times and %drug release studies were performed. Tablets containing Crospovidone, Kyron as disintegrants and Mannitol as filler were disintegrate rapidly below 20 sec and 100% drug release below 5mins.
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 FORMULATING TASTE MASKED ORALLY DISINTEGRATING TABLETS OF A BITTER DRUG IBUPROFEN

 FORMULATING TASTE MASKED ORALLY DISINTEGRATING TABLETS OF A BITTER DRUG IBUPROFEN

ABSTRACT This study is aimed at formulating taste-masked orally disintegrating tablets of a bitter drug i.e., Ibuprofen. Taste masking was carried out by fluid bed coating of extruded and spheronized pellets comprising of Ibuprofen, microcrystalline cellulose and lactose. Two marketed taste-masking systems, namely Eudragit EPO and Opadry tm were evaluated. For the formulation of orally disintegrating tablets a range of excipients such as super disintegrants, diluents, sweeteners and flavours were evaluated and a prototype formulation was selected. This prototype formulation had Eudragit EPO coated taste masked pellets and selected excipients. Its disintegration time was found to be about 8 seconds. Tablets were evaluated for their taste, disintegration time, hardness, friability, water uptake and drug release profile. It was concluded from this study that water insoluble, water permeable polymer system like Eudragit EPO can effectively taste mask bitter drugs without unduly affecting their drug release profile. As per objective of the work, the formulation was found to have a disintegration time of less than 30 seconds (about 8 seconds), had good mouth feel and organoleptic properties. With Eudragit EPO the bitterness and burning sensation of drug was significantly masked at low coating levels (15 %) without affecting the Ibuprofen release.
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The influence of formulation and manufacturing process parameters on the characteristics of lyophilized orally disintegrating tablets

The influence of formulation and manufacturing process parameters on the characteristics of lyophilized orally disintegrating tablets

Tel.: +44-121-2044183. Received: 20 June 2011; in revised form: 11 July 2011 / Accepted: 18 July 2011 / Published: 20 July 2011 Abstract: Gelatin is a principal excipient used as a binder in the formulation of lyophilized orally disintegrating tablets. The current study focuses on exploiting the physicochemical properties of gelatin by varying formulation parameters to determine their influence on orally disintegrating tablet (ODT) characteristics. Process parameters, namely pH and ionic strength of the formulations, and ball milling were investigated to observe their effects on excipient characteristics and tablet formation. The properties and characteristics of the formulations and tablets which were investigated included: glass transition temperature, wettability, porosity, mechanical properties, disintegration time, morphology of the internal structure of the freeze-dried tablets, and drug dissolution. The results from the pH study revealed that adjusting the pH of the formulation away from the isoelectric point of gelatin, resulted in an improvement in tablet disintegration time possibly due to increase in gelatin swelling resulting in greater tablet porosity. The results from the ionic strength study revealed that the inclusion of sodium chloride influenced tablet porosity, tablet morphology and the glass transition temperature of the formulations. Data from the milling study showed that milling the excipients influenced formulation characteristics, namely wettability and powder porosity. The study concludes that alterations of simple parameters such as pH and salt concentration have a significant influence on formulation of ODT.
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“Formulation and Evaluation of Orally Disintegrating Tablets of Rosuvastatin” by Rohini.P, Pavani.A, Rajareddy.R, India.

“Formulation and Evaluation of Orally Disintegrating Tablets of Rosuvastatin” by Rohini.P, Pavani.A, Rajareddy.R, India.

Accepted on: 03-11-2013; Finalized on: 31-12-2013. ABSTRACT Rosuvastatin is a dyslipidaemic agent, which acts by inhibition of HMG-CoA reductase enzyme used in the treatment of hyperlipidemia. The purpose of this investigation was to develop “orally disintegrating tablets of Rosuvastatin” by direct compression technique. Fourteen batches were prepared using various super disintegrants like sodium starch glycolate, croscaramellose sodium, LycoatRs720 and crospovidone in different concentrations. This Superdisintegrant addition method exhibits lowest disintegration time, hence it is ranked as the best among the methods. All the formulations were evaluated for weight variation, hardness, friability, in-vitro disintegration time, drug content, wetting time, in-vitro dissolution study. Among all the formulations F13 (containing 8% of super disintegrants i.e., crospovidone and sodium starch glycolate {1:1}) was considered to be the best formulation, which releases up to 97% drug in 5 minutes. A comparative study of in-vitro drug release was made with marketed product of Rosuvastatin which shows 93% drug release in one hour. From this study we can conclude that, formulated tablets of Rosuvastatin containing crospovidone and sodium starch glycolate are better and effective than conventional tablets to meet patient compliance.
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Patient Information MAXALT (max-awlt) and MAXALT-MLT rizatriptan benzoate Tablets and Orally Disintegrating Tablets

Patient Information MAXALT (max-awlt) and MAXALT-MLT rizatriptan benzoate Tablets and Orally Disintegrating Tablets

Read this Patient Information before you start taking MAXALT ® and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. Unless otherwise stated, the information in this Patient Information leaflet applies to both MAXALT Tablets and to MAXALT-MLT ® Orally Disintegrating Tablets.

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Conceptualisation, development, fabrication and in vivo validation of a novel disintegration tester for orally disintegrating tablets

Conceptualisation, development, fabrication and in vivo validation of a novel disintegration tester for orally disintegrating tablets

The USP “Guidance for Industry: Orally Disintegrating Tablets” has stipulated the need for an alternative test for measuring the disintegration time of ODT which bears closer resemblance with in vivo conditions 2 . Previous efforts have been made at conducting an in vivo relevant/correlating test, with methods ranging from the fabri- cation of tailored equipment 5–8 , to improvised methods that were developed using currently available lab equip- ment 9–16 . However, these different tests suffer from various limitations including absence of controlled conditions such as temperature and humidity as well as limited data for demonstrating in vitro/in vivo correlation (IVIVC).
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DESIGN AND DEVELOPMENT OF ONDANSETRON ORALLY DISINTEGRATING TABLETS AND ITS OPTIMIZATION USING DESIGN OF EXPERIMENT

DESIGN AND DEVELOPMENT OF ONDANSETRON ORALLY DISINTEGRATING TABLETS AND ITS OPTIMIZATION USING DESIGN OF EXPERIMENT

4. Fineness of dispersion: One Tablet is dispersed in 50 ml water and should pass through sieve # 22. 5. In-Vitro Release Profile of Formulated Tablets: Dissolution profile is very important for any Orally disintegrating Tablets, so that it matches in its efficacy with the innovator. Dissolution profile was done in USP recommended medium that is 0.1 N HCl, 500 ml media volume, USP Type II apparatus and 50 rpm. The sample of 10 ml was withdrawn at 5, 10 and 15 min and its absorbance was measured at 309 nm.
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