All formulations were evaluated for percentage drug content and found in the range of 92.16 ± 0.36 to 99.98 indicating the compliance with the Pharmacopoeia limits. According to the Pharmacopoeia standards the dispersible tablet must disintegrate within 3 min, but all formulated batches have shown very low disintegration time i.e. 30.047 to 55.083 seconds indicating suitability of formulation for mouthdissolvingtablet. Wetting time found in the range of 46±0.36 seconds and 50
Therefore, to provide the needs of such patients, recent advancements in technology have resulted in the development of viable dosage alternatives popularly known as orally disintegrating tablets (ODTs). During the past decade, the MDT (Mouthdissolvingtablet) technology, which makes tablets dissolve or disintegrate in the mouth without additional water intake, has drawn a great deal of attention. 3
Accepted: 29 Dec 2016 Recent advances in Novel Drug Delivery System (NDDS) aim for designing forms, convenient to be manufactured and administered free side effects, offering immediate release and enhanced bioavailability. So as to achieve better patient compliance, mouthdissolvingtablet is one of such delivery system. Ketoconazole was used the treatment of oral thrushes and systemic infections. A total of eight formulations were prepared using sodium starch glycolate and microcrystalline cellulose as quick breaking agents for mouthdissolvingtablet. The prepared tablet was evaluated for dissolution studies, which showed 99.9 % drug release at the end of 1 hrs.
Tinidazole mouthdissolvingtablet were prepared to achieve quick onset of action and for maximum bioavalability. The purpose of the present research work was to compare the efeect of different superdisintegrants on the mouthdissolving property of tinidazole tablets. Mouthdissolvingtablet of tinidazole were prepared using crospovidone, crosscarmellose, and sodium starch glycolate as superdisintegrants by direct compression technique. Prepared tablet were evaluated for weight variation, hardness, friability, content uniformity, wetting time, in vitro dispersion time, in vitro disintegration time and dissolution studies. Disintegration time of all prepared formulation was found to be in order: M9<M8<M6<M7<M3<M5<M4<M2<M1. Disintegration time was found to be rapid in M9 formulation. The in vitro dissolution time was found to be 96.50% in 10 minutes for the formulation M9. Crospovidone showed faster disintegration of tablets among all other superdisintegrants.
The aim of the present research work was to enhance the solubility of Glipizide by solid dispersion method and to formulate a mouthdissolvingtablet. Drugs are more frequently taken by oral administration. The solubility of Glipizide enhanced with different ratios of CCS by the kneading method .In-vitro release profile of solid dispersion obtained in Ph 6.8 phosphate buffer indicate that 100% drug release found within 20 min. These solid dispersions were directly compressed into tablets using sodium starch glycolate, crosspovidone and pregelatinised starch in different concentrations as a superdisintegrants. The prepared tablets containing the solid dispersion of Glipizide had sufficient strength of 1.5-2 kg/cm 2 . The disintegrated in the oral cavity within 21 sec. contain crosspovidone (5%) as superdisintegrant.
manufacturing process, but also to ensure that the resulting tablets have the desired properties. For instance, tablets should ufficiently strong to withstand handling during manufacturing and usage, but should also disintegrate and release the drug in a predictable and reproducible manner Drug Delivery Systems (DDS) are a strategic tool for expanding markets/indications, extending product life cycles and generating opportunities. DDS make a significant contribution to global pharmaceutical sales through market segmentation and are moving rapidly. Drug delivery systems are becoming increasingly sophisticated as scientists acquire a better understanding of the physicochemical parameters pertinent to their performance (Chein, 1992). Despite of tremendous advancements in drug delivery, the oral route remains the perfect route for the administration of therapeutic cause of low cost of therapy, ease of administration, medication, leading to high levels of patient compliance. Tablets and capsules are the most popular dosage forms (4) . It is a tablet that disintegrates and dissolves rapidly in the saliva, within a few seconds without the need of drinking water or chewing. A mouthdissolvingtablet usually dissolves in the oral cavity within 15 second to 3min.
On the basis of obtained results it can be concluded that the solubility of cinnarizine was increased by solid dispersion technique using PVP K30 as carrier. Formulation of MDT by using SD of Cinnarizine is unique technique by which solubility of the drug can be enhanced which is most challenging aspect of drug delivery. The technique adopted was found to be economical and industrially feasible. Thus, it can be concluded that combination of solid dispersion and super disintegrants is a promising approach to prepare efficient mouthdissolvingtablet of poorly water soluble drug i.e. Cinnarizine.
is the one, which immediately attains the desire and maintain constant for the entire duration of devoted considerable efforts for developing a novel type mouthdissolving tablets (MDT). It is define as “a tablet that seconds without the need of drinking water or within 15sec to 30sec Most of the MDTs Telmisartan (TLM) is a non-peptide Angiotensin ATI) antagonist, that cause inhibition of action of Angiotensin II on vascular smooth muscle in the treatment of hypertension. The bioavailability of telmisartan is poor about 45% which is due to extensive first pass hepatic metabolism. The bioavailability can be increased by fast dissolving formulation. Conventional telmisartan tablets available in markets are not suitable were quick onset of action is required. In order for better atient compliance its better to develop a dosage form that can rapidly disintegrate and dissolve in saliva without The aim of present investigation was to prepare mouthdissolvingtablet of an anti hypertensive drug ty of poorly soluble drug was enhanced by preparing inclusion complexes (solvent evaporation and kneading method) with β cyclodextrin and PEG 4000 in various concentrations. The optimized suitable proportion of superdisintegrant such as crosscarmellose, sodium starch glycolate and crosspovidone. Mouthdissolving tablets of Telmisartan was compressive parameters for the blends and post compressive parameter for the prepared tablet were evaluated. All formulation showed desired pre and post-compressive characteristics. FTIR study showed no evidence of drug excipient interaction. The optimized formulation was t Mouthdissolvingtablet of Telmisartan can be prepared by inclusion complexes with cyclodextrin and combination of superdisintegrants provide complete and better dissolution within in shorter period of time. Hypertensive treatment anywhere, and anytime particularly for ageriatric, pediatric,
The aim of present work was to formulate and evaluate mouthdissolvingtablet of Bambuterol Hydrochloride to minimize the disintegration time and improve % drug release. Bambuterol Hydrochloride is an Antiasthmatic drug. Mouthdissolvingtablet was formulated using Camphor as a subliming agent. Sodium deoxycholate and Cross povidone were added as permeation enhancer and as a super-disintegrant respectively. Optimization was done by 3 2 full factorial design and developed formulation was evaluated for In-vitro drug release study and Ex-vivo diffusion study. Concentration of Camphor and Sodium deoxycholate were selected as independent variables. All formulations were evaluated for properties such as weight variation, hardness, friability, drug content, disintegration time, wetting time study, In-vitro dissolution study, Ex-vivo diffusion study. % In-vitro drug release and % Ex-vivo permeation at 10 min were selected as dependent variables. Analysis of variance was performed for dependent variables. In-vitro release data was fitted to various kinetic models of drug release. Optimized formulation batch (B9) had complies the acceptance criteria and was found to be stable for 1 month. % In vitro drug release and % ex-vivo permeation of optimized formulation were found to be 90% and 78.46% at 10 min respectively.
Mouthdissolvingtablet is a novel dosage form, have several characteristics to distinguish them from the more traditional dosage form. The purpose of this research was to prepare mouthdissolvingtablet of tramadol hydrochloride by sublimation method with a view to enhance patient compliance. Tramadol hydrochloride is a centrally acting analgesic, which is orally and intravenously administered drug. The sublimating agent used in this study was camphor & ammonium bicarbonate, The prepared batches of tablets were evaluated for uniformity of weight, thickness, hardness, friability, wetting time, water absorption ratio, disintegration time and dissolution study. Amongst all formulations, formulation F3 prepared by 5% crosscaramellose sodium & 15% camphor showed least disintegrating time and faster dissolution.
MDTs is regarding as a good candidates for the patients with persistent nausea, who are traveling, or who have little or no access to water. The objective of present research work was to prepare and evaluate the mouthdissolvingtablet of Lacosamide using Super disintegrants like Guar Gum, and other excipients like Microcrystalline Cellulose and Mannitol in different concentrations by Direct Compression method. Lacosamide has been shown to be an effective antiepileptic agent appropriate for the epilepsy patients. Effect of different formulation variables i.e. amount of polymer and type of polymer was studied on release profile and other characteristics. The mouthdissolving tablets were prepared by single punch machine using powder blend of superdisintegrant and Lacosamide. Post-compression parameters like Hardness, weight variation, friability, In-Vitro dispersion, Drug content uniformity and In-vitro drug release studies were carried out for all the formulation. All the Formulations gave the result within the official limits. The prepared mouthdissolvingtablet shows the properties of fast disintegration time (28 sec to 47 sec) within official limit. By the in-vitro disintegration, it is concluded that formulation F2 prepared by Guar Gum (10%) showed the fast disintegration time than the MCC. Therefore, it may be concluded that mouthdissolvingtablet was suitable choice for delivery system of Lacosamide.
Many patient groups, such as the elderly, children, mentally retarded, uncooperative or nauseated, have difficulty in swallowing conventional dosage forms, like tablets. Swallowing conventional tablets will be further hindered by conditions such as unavailability of water, allergic reactions and episodes of coughing[1]. These problems can be solved by developing rapidly disintegrating and dissolvingtablet dosage forms for oral administration, because they dissolve in saliva and does not require water for swallowing. Upon ingestion, the saliva serves to rapidly dissolve the dosage form. The saliva containing the dissolved or dispersed medicament is then swallowed and the drug is absorbed in the normal way. Some drugs are absorbed from the mouth, pharynx and oesophagus, as the saliva passes down in to the stomach. In these cases, the bioavailability of drugs is significantly greater than those observed from conventional dosage forms[2]. The bioavailability of some drugs may be increased due to absorption of drugs in oral cavity and also due to pregastric absorption of saliva containing dispersed drugs that pass down into the stomach. Moreover, the amount of drug that is subjected to first pass metabolism is reduced as compared to standard tablets[3]. A wide range of drugs requiring quick onset of action are the promising candidates for this dosage form. These include neuroleptics, antidepressants, cardiovascular drugs, analgesics and so on.
In the present investigation FDTs of Quetiapine fumarate were prepared by direct compression method. Flow properties of the powder, resistance to particle movement can be judged from the angle of repose. Values for angle of repose were found in the range of 25.63 to 36.811°. Carr’s index of the prepared blends falls in the range of 12.0 to 22.554 % and this is also supported by Hausner factor values which were in the range of 1.16 to 1.2. Hence the prepared blends possessed good flow properties and these can be used for tablet manufacture.
Formulation of a convenient dosage form for ad- ministration, by considering swallowing difficulty and poor patient compliance, leads to development of rapidly disintegrating oral tablets. This are also called mouthdissolving, mouth disintegrating and fast melt system. This disintegrates in the mouth in seconds without chewing and the need of water which is advantageous mainly for pediatrics, geria- trics and patients having difficulty in swallowing tablets and capsules (1) . Prochlorperzine maleate is a
This work was initiated to formulate and evaluate MDTs of meloxicam. From the study, it can be concluded that direct compression can be applied effectively in the preparation of MDTs. In this work, solid dispersion was used to increase the solubility of the drug, and it also to taste mask of a drug. PEG was used as a taste masking agent. Solid dispersion prepared with PEG 15,000 with the drug to carrier ratio 1:2 found to give maximum solubility in compare with PEG 6000. In house prepared banana powder was found to be superior as compared to the combination of natural and artificial superdisintegrant. In house prepared fresh banana powder gave a promising effect in comparison to the marketed banana powder as natural superdisintegrant. The addition of SLS in the formulation has shown an increase in the tablet strength to prevent failure of friability testing. It was concluded that the use of natural banana powder as a superdisintegrant in a formulation of MDTs of meloxicam is more promising with respect to economical and compatibility for geriatric patients.
with the bottom surface made of a stainless steel screen (mesh no. 10) was immersed in water bath at 37 ± 20C. The time required for complete disintegration of the tablet in each tube was determined using a stop watch. To be complied with the Pharmacopoeial standards, dispersible tablets must disintegrate within 3 min when examined by the disintegration test for tablets.
Weight Variation Test: Weight variation test is performed to check that the manufactured tablets have a uniform weight. As per USP, twenty tablets are weighed individually, and compendia weight is taken, the average weight is obtained by dividing compendia weight by 20 tablet weight, now the average weight is compared with the individual weight of the tablet. For a tablet to pass the test not more than 2 tablets should lie out of the specified percentage and if no tablet differs by more than two times the percentage limit 6 .
To overcome these problems mouthdissolving tablets are the best choice of formulation. These tablets get disintegrated or dissolved in buccal cavity avoiding water consumption. This is a newer dosage form that gets dissolved in saliva in very few seconds. these tablets are also known as melt in mouthtablet (MMT), Fast melting tablet (FMT), Fast dissolvingtablet (FDT), Orally Disintegrated tablet (ODT), Rapidly Disintegrated tablet (RDT). [3]
The pharmacopoeial limit of friability test for a tablet is not more than 1% using table friability apparatus, carried out at 25 rpm for 4 min (100 rotations. However, it becomes a great challenge for a formulator to achieve friability within this limit for MDT product keeping hardness at its lowest possible level in order to achieve a minimum possible disintegration time. This test is again not applicable for lyophilized and flash dose tablets, but is always recommended for tablet speared by direct compression and molding techniques to ensure that they have enough mechanical strength to withstand the abrasion during shipping and shelf life 11, 14 .
Drug release study in simulated salivary fluid pH 6.8 & 0.1 N HCl: The drug release method for mouthdissolving tablets is comparable to the approach to the approach taken for conventional tablets, and is practically identical. The release study carried out in USP Type 2 dissolution apparatus containing 900ml 6.8 pH phosphate buffer and 0.1 N Hcl at 50 rpm and 37 o C temperature. The drug release sample 5ml withdrawal by suitable time interval and fresh dissolution medium were added in the each withdrawal. Then appropriate dilution of the samples has been prepared and absorbances of the resulting solution were taken spectrophotometrically