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Modified Xanthan Gum as Hydrophilic Disintegrating Excipient for Rapidly Disintegrating Tablets of Roxithromycin

Modified Xanthan Gum as Hydrophilic Disintegrating Excipient for Rapidly Disintegrating Tablets of Roxithromycin

In this context, the present study was aimed to mod- ify, xanthan gum by simple technique, characterize, and assess its lag time reducing properties by for- mulating and evaluating rapidly disintegrating tablets of the model drug roxithromycin and to evaluate the effect of aging on hardness, disintegration time, drug content and in vitro drug release of the rapidly disintegrating tablets after storage of one year. Roxithromycin, erythromycin 9-{O-[(2-methoxye- thoxy)methyl]oxime} is a macrolide antibiotic used in the treatment of wide variety of infections like bron- chitis, severe campylobacter enteritis, chancroid, diph- theria, legionnaires, pneumonia sinusitis and trench fever. 10 Following oral administration, roxithromycin

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Selection of superdisintegrant for Famotidine rapidly disintegrating tablets

Selection of superdisintegrant for Famotidine rapidly disintegrating tablets

For tablets and capsules which require rapid disintegration, the inclusion of the right superdisintegrant and in its optimum concentration is a prerequisite for optimal bioavailability. Superdisintegrants decrease disintegration time which in turn enhances drug dissolution rate. Thus, the proper choice of disintegrant / superdisintegrant and its consistency of performance are of critical importance to the formulation of rapidly disintegrating dosage forms.

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“FORMULATION AND IN VITRO EVALUATION OF RAPIDLY DISINTEGRATING TABLETS USING CAPTOPRIL AS A MODEL DRUG” by A. O. Kabra *, F. B Shah, R.S. Wanare, India.

“FORMULATION AND IN VITRO EVALUATION OF RAPIDLY DISINTEGRATING TABLETS USING CAPTOPRIL AS A MODEL DRUG” by A. O. Kabra *, F. B Shah, R.S. Wanare, India.

The present study was aimed towards the formulation and in vitro evaluation of rapidly disintegrating tablets by direct compression technology using Captopril as a model drug. Rapidly disintegrating tablet of Captopril was formulated using three Superdisintegrants in different concentrations i.e. 4%w/w, 8%w/w and 12%w/w and one disintegrants having concentration i.e. 2% w/w/, 4% w/w and 6% w/w like Croscarmellose sodium, Crospovidone, Sodium Starch Glycolate and Indion 414. All the batches were prepared by direct compression method using the Cadmach Single punch tablet compression machine using 8 mm flat punch. Disintegration time and drug release were taken as the basis to optimize the immediate release tablet. Prepared tablets were evaluated for thickness, hardness, friability, uniformity of weight, disintegration time, wetting time and dissolution study. Crospovidone in the concentration of 12 % gives fasted disintegration in 22 sec. and shows and 80% drug release in 10 min at gastric pH is selected as the optimized formulation. Selected formulation was subjected to stability studies for thirty days which showed stability with regards to release pattern.

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FORMULATION AND IN VITRO EVALUATION OF RAPIDLY DISINTEGRATING TABLETS OF LORATADINE

FORMULATION AND IN VITRO EVALUATION OF RAPIDLY DISINTEGRATING TABLETS OF LORATADINE

CONCLUSION: Rapidly Disintegrating Oral Tablets of Loratadine is successfully prepared by using different proportions of superdisintegrants, Formulation F8 having Ac-Di-Sol (Crosscarmellose sodium) as the superdisintegrant is the best formulation among of all 8 formulations. Undoubtedly the availability of various technologies and manifold advantages of rapidly disintegrating tablets will surely enhance the patient compliance, low dosing, low side effect, good stability, and its popularity in the near future.

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 FORMULATION AND EVALUATION OF CHLORPHENOXAMINE HYDROCHLORIDE RAPIDLY DISINTEGRATING TABLETS

 FORMULATION AND EVALUATION OF CHLORPHENOXAMINE HYDROCHLORIDE RAPIDLY DISINTEGRATING TABLETS

Six formulae of rapidly disintegrating tablets were prepared. All formulations contain Chlorphenoxamine hydrochloride: different types of superdisintegrants were used such as Crosscarmellose Sodium (Ac-Di-Sol), Crosspovidone and Sodium Starch Glycolate. Each superdisintegrant was added in different a concentration 2.5 mg and 5 mg as shown in Table 2. All the ingredients were passed through mesh 60. Required quantity of each ingredient was taken for each specified formulation and all the ingredients were co grind in a mortar and pestle. Mannitol is used as directly compressible diluent. The powder blend was evaluated for their flow properties such as bulk density, tapped density, angle of repose, Carr’s compressibility index and Hausner’s ratio 5 .

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Taste Masking of Tramadol Hydrochloride by Polymer Carrier System and Formulation of Rapidly Disintegrating Tablets using Factorial Design.

Taste Masking of Tramadol Hydrochloride by Polymer Carrier System and Formulation of Rapidly Disintegrating Tablets using Factorial Design.

The objective of this study was to formulate and optimize taste masked rapidly disintegrating tablet of intensely bitter drug tramadol hydrochloride by 3 factorial design. The drug polymer complex was prepared by coacervation method using aminoalkyl methacrylate copolymer (Eudragit EPO) as polymer and sodium hydroxide as precipitant and characterized for molecular properties, drug content, in vitro dissolution and taste evaluation. Drug polymer complex with a ratio of 1:8 was selected based on no release in phosphate buffer pH 6.8 showing successful taste masking of drug. Bitterness score was evaluated by human gustatory sensation test. The bitterness score of drug polymer complex was decreased as compared to tramadol hydrochloride. Optimized drug polymer complex was

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Preparation of tablets rapidly disintegrating in saliva containing bitter taste-masked granules by compression method

Preparation of tablets rapidly disintegrating in saliva containing bitter taste-masked granules by compression method

found to be tasteless, so they were compressed into rapidly disintegrating tablets. Different ratios of the super­ disintegrant, SSG and the directly compressible binder, MCC were also tried for the formulation of RDTs and the ratio that gave the minimum disintegrating time along with acceptable hardness was chosen for the formulation of the final batch of tablets. From Table 1, it can be observed that although the ratios of SSG:MCC below ratio 1:3 gave very less disintegration times (less than 19 s) but tablet hardness was also very less, resulting in very friable tablets. All the ratios above 1:6 (i.e., formulations CT-7 to CT-12) gave very high disintegration times and therefore, were rejected. The formulation CT-5 was selected for the preparation of final batch of RDTs as acceptable hardness and rapid disintegration was observed. Various physical parameters of this batch of tablets are summarized in Table 3. Also a linear correlation between the disintegration time and wetting time of the RDTs was observed suggesting that wetting is an important step for the disintegration process (fig. 1). Figs. 2 and 3, show the dissolution profiles of taste- masked RDTs as well as of control (pure drug) RDTs of CPM. In phosphate buffer pH 6.8, a cumulative percent

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EFFECT OF MANNITOL AND MCC ON RAPIDLY DISINTEGRATING TABLETS

EFFECT OF MANNITOL AND MCC ON RAPIDLY DISINTEGRATING TABLETS

providing fast dissolution and pleasant mouth feeling to the patient. Thus such dosage form will be convenient and acceptable to use. [10] Recently, pharmaceutical preparations used for elderly patients have been investigated to improve the treatment, compliance and quality of life of such patients. A tablet which can rapidly disintegrate in saliva (rapidly disintegrating tablet) is an attractive dosage form and a patient-oriented pharmaceutical preparation. The mouth-dissolving tablets have attracted the interest of many researchers. Many elderly patients have difficulty swallowing tablets, capsules, or powders. To alleviate this problem, these tablets are expected to dissolve or disintegrate in the oral cavity without drinking water. The disintegrated mass can slide down smoothly along the esophagus with the help of saliva, so even people who have swallowing or chewing difficulties can take it with ease. [4]

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 FORMULATION AND EVALUATION OF TASTE MASKED RAPIDLY DISINTEGRATING TABLET CONTAINING FLUPENTIXOL DIHYDROCHLORIDE

 FORMULATION AND EVALUATION OF TASTE MASKED RAPIDLY DISINTEGRATING TABLET CONTAINING FLUPENTIXOL DIHYDROCHLORIDE

All the formulations exhibited white colour, odourless, biconvex in shape with smooth surface. Since the powder material was free flowing, tablets were obtained of uniform weight due of uniform die fill, with acceptable weight variations. The average weight of the rapidly disintegrating tablets( RDTs) prepared by direct compression method was 123 ± 0.004 to 126 ± 0.003 mg. Hardness and friability of all formulations were within acceptable limits. Hardness of tablets prepared by direct compression was 8.5 ± 0 .670 to 10.5 ± 1.204 kg/cm2. The friability of all formulations was found to be less than 1.0 % and hence the tablets with lower friability may not break during handling on machines and or shipping. The drug content was found in the range of 98% ± 1.910 - 100.3% ±2.002. Disintegration time is very important for RDTs which is desired to be less than 60 seconds for orally disintegrating tablets. This rapid disintegration assists swallowing and also plays a role in drug absorption in buccal cavity, thus promoting bioavailability. Disintegration time of prepared RDTs was in the range of 11.833 ± 1.4624 to 61 ± 2.409 seconds. The disintegration time is higher for control F1 (150 sec) and F10 shows fast disintegration time of 11.80 second. Wetting time is used as an indicator from the ease of the tablet disintegration in buccal cavity. It was observed that wetting time of tablets was in the range of 13 ± 2.409 to72.33± 1.598 second but recorded 160±1.302 for control tablets F1. The tablets were evaluated for the in vivo disintegration time and it was observed that the time for all the formulations varied from 12.6 ±1.496 to 46 .8 ± 0.4; while it was 155 ± 0.432 for control tablets F1.It was observed that when crospovidone was used as disintegrant, the tablet disintegrated rapidly within a short time due to the easy swelling ability of crospovidone when compared with other tablets prepared using Crosscarmellose sodium and sodium starch glycolate. It is observed that the disintegration time of the tablets decreased with an increase in the level of superdisintegrants. The characteristics of prepared RDTs of Flupentixol dihydrochloride are shown in Table 3 and figures 1 and 2.

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Preparation and Evaluation of Rapidly Disintegrating Fast Release Tablet of Diazepam Hydroxypropyl β Cyclodextrin Inclusion Complex

Preparation and Evaluation of Rapidly Disintegrating Fast Release Tablet of Diazepam Hydroxypropyl β Cyclodextrin Inclusion Complex

It was also noted that the type of soluble diluents in- fluenced the porosity, wetability and disintegration time of the tablets considerably. The tablets prepared with MCC/lactose combination exhibited higher % of porosity, and shorter wetting and disintegration times followed by the tablets prepared with MCC/manitol and MCC/sorbi- tol. Change of soluble excipient from sorbitol to mannitol to lactose significantly increased (p < 0.05) the porosity and decreased the wetting time and disintegration time of the tablets. These observations were found in each of the ratios of MCC/soluble diluents. The solubility data [41] indicate that aqueous solubility of the above used ex- cipients increased in the following order: lactose > man- nitol > sorbitol. Higher solubility of lactose was respon- sible for its rapid solution. As lactose dissolves quickly it creates pores rapidly encouraging penetration of water into the tablets and this led to quick disintegration of the tablets. Decrease in solubility of the excipients delayed both the wetting and disintegration of tablets.

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A NOVEL RAPIDLY DISINTEGRATING TABLET OF SILDENAFIL CITRATE WITH ENHANCED STABILITY: DESIGN AND IN-VITRO EVALUATION

A NOVEL RAPIDLY DISINTEGRATING TABLET OF SILDENAFIL CITRATE WITH ENHANCED STABILITY: DESIGN AND IN-VITRO EVALUATION

A method for the determination of sildenafil citrate in the presence of its oxidative-induced degradation products using reversed phase HPLC was described by Segall et al. (5). However, literature lacks any data about the use of antioxidants and microenvironmental pH adjustment as an approach to enhance the stability of the drug as well as, its formulation in the form of rapidly disintegrating tablets. Thus, the aim of this work was to investigate the effect of different pH values and different antioxidants on the stability of sildenafil citrate, and to select the most appropriate microenvironmental pH adjuster and antioxidant to be incorporated in the prepared tablets. The drug was then formulated in the form of rapidly disintegrating tablets and the prepared tablets were evaluated for weight variation, content uniformity, friability, hardness, disintegration and in-vitro dissolution. In addition, the effect of storage at 50 ºC/75 % R.H for twelve weeks on the properties of the selected tablet formulations was investigated.

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Design and Evaluation of Rapidly Disintegrating Tablets of Racecadotril with Enhanced in-vitro Dissolution Achieved by Solid Dispersion Technique

Design and Evaluation of Rapidly Disintegrating Tablets of Racecadotril with Enhanced in-vitro Dissolution Achieved by Solid Dispersion Technique

Racecadotril is an antidiarrheal drug which acts as a peripherally acting enkephalinase inhibitor. It is a solubility limited compound and thus the bioavailability can be improved by increasing its aqueous solubility. Solid dispersions of racecadotril were prepared using polymers β-cyclodextrin, poloxamer 188 (Lutrol F 68) and poloxamer 407 (Lutrol F127) in different proportions (1:1, 1:3, 1:5 and 1:10). Solvent evaporation method was employed using methanol as solvent. The solid dispersion complexes were also characterized using FT-IR, DSC and XRD. The optimized dispersions were formulated into rapid disintegrating tablets using Kollidon® CL-SF and sodium starch glycolate (SSG) as disintegrants with proportion of 2%, 3%, and 4%. The disintegration time, mean dissolution time (MDT), T 50 and T 90 of the formulated tablets were evaluated and compared with the marketed formulation. The pure drug showed aqueous solubility of 18.89 μg/ml while the solid dispersions with poloxamer 188 and poloxamer 407 in ratios 1:5 showed solubility of 70.75 μg/ml and 58.07 μg/ml. There was a 3 fold increase in drug solubility. The disintegration time of all the formulations were found to be less than 42 sec. Both Kollidon® CL-SF and SSG decreased the T 50 and T 90 values but Kollidon® CL-SF at a concentration of 4% was found to show the best results (T 50 = 10.63 ± 0.17, T 90 = 35.31 ± 0.57 and MDT = 13.85 ± 0.27 min). This was further compared with marketed formulation. The difference (f1) and similarity (f2) factors was found to be 89.91 and 21.11 respectively. The results suggest that the designed formulation is improved than the marketed formulation. The improved solubility, dissolution and drug release may be highly beneficial in improving the overall bioavailability of RDT.

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Hydralazine HCl rapidly disintegrating sublingual tablets: simple dosage form of higher bioavailability and enhanced clinical efficacy for potential rapid control on hypertensive preeclampsia

Hydralazine HCl rapidly disintegrating sublingual tablets: simple dosage form of higher bioavailability and enhanced clinical efficacy for potential rapid control on hypertensive preeclampsia

HHC sublingual tablets were prepared using different super disintegrants at various levels to be used as IV substitute for rapid control on hypertensive emergency, especially in preeclampsia cases. Depending on the evaluation results it could be concluded that the prepared sublingual tablet formulations showed high compatibility without any pos- sibility of chemical interaction as confirmed by DSC and IR studies. Also the prepared tablets showed good mechanical properties with high disintegrating power as indicated by the very short disintegration time. The percentage drug release Table 5 One-way anOVa test for systolic blood pressure data

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DEVELOPMENT AND EVALUATION OF RAPIDLY DISINTEGRATING TABLETS OF CANDESARTAN

DEVELOPMENT AND EVALUATION OF RAPIDLY DISINTEGRATING TABLETS OF CANDESARTAN

In the present work, Rapidly disintegrating tablets of Cadesartan cilexetil were designed with a view to enhance patient compliance by direct compression method. In the direct compression method, crospovidone, croscarmellose sodium, sodium starch glycolate as superdisintegrants were used along with Sweeteners and flavours were used to enhance the organoleptic properties of tablet. Tablets were prepared by direct compression technique. Directly compressible microcrystalline cellulose to enhance mouth feel. Tablets were prepared by direct compression technique. Prepared tablets were evaluated for thickness, uniformity of weight, hardness, friability, wetting time, in -vitro disintegration time, drug content and in vitro drug release. Short-term stability (40 0 C/ 75% RH for 3 months) and drug-excipient interaction study (IR spectroscopy) are also were studied. Disintegration time and drug release were taken as the basis to optimize the rapidly disintegrating tablet. All the formulations were evaluated for the influence of disintegrates and their concentrations on the characteristics of rapid disintegrating tablets mainly in terms of disintegration time and dissolution studies. The disintegration time of all formulation showed less than 37 seconds. Among the three superdisintegrants used, Crospovidon showed less disintegrating time followed by crosscarmellose sodium and sodium starch gycolate. The relative efficiency of different superdisintegrants to improve the drug rate of tablets was in order, crospovidon> Crosscarmellose sodium >sodium starch gycolate.

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FORMULATION OF A RAPIDLY DISINTEGRATING MATRIX USED FOR THE FORMULATION OF ORODISPERSIBLE TABLET

FORMULATION OF A RAPIDLY DISINTEGRATING MATRIX USED FOR THE FORMULATION OF ORODISPERSIBLE TABLET

of this study, is to improve the quality of certain disintegrants (such as sodium crosscarmellose) by forming a rapidly disintegrating matrix composed of the latter with another disintegrating having super power used at low concentration to rationalize its quantity in the formula. For this purpose, the objective of the present research is focused on the the effect of several disintegrants separately (croscarmellose sodium and sodium starch glycolate, crospovidon, starch pre- gelatinized, low substituted hydroxypropylcellulose (HPC-L), in order to select the best and the bad disintegrants on the mouth dissolving property of Piroxicam tablets matrix. The second part is devoted to the formulation of a rapidly disintegrating composed of two disintegrating used previously (the bad and best one).

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Justification of disintegration testing beyond current FDA criteria using in vitro and in silico models

Justification of disintegration testing beyond current FDA criteria using in vitro and in silico models

Abstract: Drug product performance testing is an important part of quality-by-design approaches, but this process often lacks the underlying mechanistic understanding of the complex interactions between the disintegration and dissolution processes involved. Whereas a recent draft guideline by the US Food and Drug Administration (FDA) has allowed the replacement of dissolution testing with disintegration testing, the mentioned criteria are not globally accepted. This study provides scientific justification for using disintegration testing rather than dissolution testing as a quality control method for certain immediate release (IR) formulations. A mechanistic approach, which is beyond the current FDA criteria, is presented. Dissolution testing via United States Pharmacopeial Convention Apparatus II at various paddle speeds was performed for immediate and extended release formulations of metronidazole. Dissolution profile fitting via DDSolver and dissolution profile predictions via DDDPlus™ were performed. The results showed that Fickian diffusion and drug particle properties (DPP) were responsible for the dissolution of the IR tablets, and that formulation factors (eg, coning) impacted dissolution only at lower rotation speeds. Dissolution was completely formulation controlled if extended release tablets were tested and DPP were not important. To demonstrate that disintegration is the most important dosage form attribute when dissolution is DPP controlled, disintegration, intrinsic dissolution and dissolution testing were performed in conventional and disintegration impacting media (DIM). Tablet disintegration was affected by DIM and model fitting to the Korsmeyer–Peppas equation showed a growing effect of the formulation in DIM. DDDPlus was able to predict tablet dissolution and the intrinsic dissolu- tion profiles in conventional media and DIM. The study showed that disintegration has to occur before DPP-dependent dissolution can happen. The study suggests that disintegration can be used as performance test of rapidly disintegrating tablets beyond the FDA criteria. The scientific criteria and justification is that dissolution has to be DPP dependent, originated from active pharmaceutical ingredient characteristics and formulations factors have to be negligible.

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Mouth Dissolving Tablets-Pediatric and Geriatric Patient Compliance Dosage Forms

Mouth Dissolving Tablets-Pediatric and Geriatric Patient Compliance Dosage Forms

It is the easiest technique used for manufacturing of mouth dissolving tablets . In this method traditional equipment and generally available excipients are used and low manufacturing cost. High doses can receive end weight of the tablet which can overtake the other production methods. It is important to choose a correct concentration of disintegrant to get fast disintegration. Superdisintegrants provides quick disintegration as they are more effective at lower concentrations with high disintegrating efficiency and mechanical strength. according to the critical concentration of disintegrant the optimum concentration of super disintegrate is selected, if the concentration of the tablet disintegration is below then critical concentration then disintegration time is inversely proportional to the concentration of super disintegrant or if the concentration of the tablet disintegration is above the critical disintegration than the disintegration time remains the same or even increases.

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FORMULATION AND EVALUATION OF ORAL DISINTEGRATING TABLETS OF URAPIDIL

FORMULATION AND EVALUATION OF ORAL DISINTEGRATING TABLETS OF URAPIDIL

This dosage form combines the advantages of dry and liquid formulation. Some novel ODT technology allow high drug loading, have an acceptable taste, offer a pleasant mouth felling, leaving minimal residue in the mouth after oral administration. ODT have been investigated for their potential in improving bioavaibility of poorly soluble drug through enhancing the dissolution profile of the drug and hepatic metabolism drugs. Orally disintegrating tablets are also called as orodispersible tablets, quick disintegrating tablets, mouth dissolving tablets, fast disintegrating tablets, fast dissolving tablets, rapid dissolving tablets, porous tablets, and rapimelts. However, of all the above terms, United States pharmacopoeia (USP) approved these dosage forms as ODTs. Recently, European Pharmacopoeia has used the term orodispersible tablet for tablets that disperses readily and within 3 min in mouth before swallowing.

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FORMULATION, DEVELOPMENT AND IN-VITRO EVALUATION OF ORODISPERSIBLE TABLETS OF LAMOTRIGINE

FORMULATION, DEVELOPMENT AND IN-VITRO EVALUATION OF ORODISPERSIBLE TABLETS OF LAMOTRIGINE

Oral drug delivery through is the most common and preferred route of drug administration both for solid and liquid dosage forms. However, solid dosage forms are popular because of the ease of administration, accurate dosage, self-medication, pain avoidance at site of administration, and most importantly the patient compliance. Tablets and capsules are popular solid dosage forms. However, many people face difficulty in swallowing tablets and hard gelatin capsules, called dysphasia. It has been found that this problem has been encountered in all groups of patient, but especially with pediatric and geriatric populations. Specially in the case of pediatric, geriatric patients, these conventional dosage forms result in high incidence of noncompliance and ineffective therapy with respect to swallowing, or any mentally retarded persons. Orodispersible tablets are also called as orally disintegrating tablets, mouth-dissolving tablets, rapid-dissolving tablets, fast-disintegrating tablets, fast-dissolving tablets. Recently, European Pharmacopoeia has used the term orodispersible tablets. This may be defined as uncoated tablets intended to be placed in the mouth where they disperse readily within 3 min before swallowing. United States Pharmacopoeia has also approved these dosage forms as orodispersible tablets. Thus, orodispersible tablets are solid unit dosage forms like conventional tablets, but are composed of super disintegrants, which help them to dissolve the tablets within a minute in the mouth in the presence of saliva without any difficulty of swallowing. It offers several advantages with respect to its stability, administration without water, accurate dosing, easy

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DEVELOPMENT OF ONDANSETRON HCL FAST DISINTEGRATING TABLETS USING 32 FULL FACTORIAL DESIGN

DEVELOPMENT OF ONDANSETRON HCL FAST DISINTEGRATING TABLETS USING 32 FULL FACTORIAL DESIGN

concluded that, by adopting a systematic formulation approach, an optimum point can be reached in the shortest time with minimum efforts. Direct compression method by using natural superdisintegrants would be an effective approach compared with the use of more expensive excipients in the formulation of fast disintegrating tablets with smaller disintegration time, improved drug dissolution, patient compliance, convenience and acceptability.

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