orally disintegrating tablets formulation

2021/05/21

; CHABUKSWAR, A.R. Clopidogrel hydrogen sulphate (CL) was kindly donated by Tabuk Pharmaceutical manuf. The method used for preparation of series C, D, E and F formulations and physicochemical tests conducted were the same as series B formulations. Rev., v.85, p.28-35, 2001.; Mostafa, Ibrahim, Sakr, 2013MOSTAFA, H.F.; IBRAHIM, M.A. Series D formulations were made by the addition of xylitol and aspartame to formulation F17, extra-granularly. Only two volunteers out of ten complained of a mild bitter after taste. ; KUPPASAD, I.J. The new PMC design is here! Res., v.2, n.1, p.15-23, 2014.).

Moreover, Jagdale et al. THE UNITED STATES PHARMACOPEIA (USP). Asian J. Tech., May, p.18-25, 2008.). Stage 1 Mixing Then, all the mentioned components including the quickly soluble granules except for the lubricant, were mixed by the geometrical dilution method and finally lubricant was added. tablets orally disintegrating claritin Sharma S, Gupta GD. P-values less than 0.5 were considered as significant in all the above-mentioned tests. For this purpose, a matrix-type ODT system was produced using special polymers, water soluble excipients, super-disintegrants and quickly soluble granules. Pharm. AlC)m disso, estudou-se a interaC'C#o de clopidogrel com os excipientes de formulaC'C#o, utilizando calorimetria de varredura diferencial (DSC). Identifies critical formulation parameters such as collapse temperature, eutectic/glass transition temperature, Particle size analysis (laser diffraction) buccal, sublingual, oesophageal), pH relatively neutral (5.5 7.2 depending on salivary flow rate), Potential for sublingual / buccal absorption, Solid, unit doses presented in protective pack, Low temperature processing minimizes manufacturing losses of labile drugs, Solution / suspension dosing achieves good content uniformity for low dose actives, Solid dosage form and low water activity aids long term stability, Liquid processing facilitates containment of potent drugs in production, Tailored to meet the known product requirements such as API unit dose, Consideration of the relevant API characteristics identified during the technical evaluation of preformulation data, A range of prototype Zydisformulations prepared under different processing conditions (bench-scale); analytical techniques applied as appropriate to determine the compatibility of a candidate API with the Zydistechnology, Short-term (4 week) accelerated physical stability studies typically undertaken before recommendations for a full development program are made, Operational excellence and efficiency via Lean Six Sigma principles, Full in-house analytical and regulatory services, Full characterization of your API and associated Zydisformulations via expert analysis and interpretation of data throughout the development process to provide a robust data package in support of regulatory filings, Smart full-lifecycle management from molecule to market with Lean efficiency standards, Expert handling and maximization of potent and controlled drugs, Bench, pilot, and full-scale cGMP manufacturing, Pilot line with controlled and potent drug capabilities, FDA and MCA audited Controlled drug capabilities. For this purpose different tablet formulations of ibuprofen were prepared. The United States Pharmacopeial Convention: Rockville MD, 2011. SURESH, B.; KUMAR, M.; RAMESH, G.; MADHUSUDAN, R. Orodispersible tablets: an overview. Microcrystalline cellulose (Avicel(r) PH101) was purchased from Serva Feinbiochemica (Heidelberg, Germany). JARVIS, B.; SIMPSON, K. Clopidogrel: a review of its use in the prevention of atherothrom-bosis. Tablets formulated without superdisintegrants exhibited a disintegration time of about 236 seconds. ; NAZ, S.; MUNEER, F.; IRFAN, U.; AYUB, M. Assay of clopidogrel hydrogen sulphate in tablet form from different manufacturing sources by using UV spectroscopy. Formulation, evaluation and optimization of fast dissolving tablet containing tizanidine hydrochloride. This formulation had PVP, ibuprofen and croscarmellose as the intra-granular components and xylitol and saccharin as the extra-granular ingredients. Pharm.

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All the prepared tablets were found to disintegrate fast. will also be available for a limited time. ; LACHMAN, L.; SCHWARTZ, J.B. Moreover, there was a significant difference between the taste of formulation F22s with other formulations (Wilcoxon test, p < 0.05).

), where the disintegration time of clopidogrel tablets containing Polyplasdone XL showed the fastest release in compendial medium (pH 2.0), compared with SSG and croscarmellose sodium. In vitro drug release studies of the ODTs showed that more than 90% of the drug was released within ten minutes. BIRADAR, S.S.; BHAGAVATI, S.T. Res., v.2, n.2, p.65-72, 2010.) HPLC was used for the assay of active ingredient after weighting and powdering 20 tablets randomly (26). Co, Tabuk, Saudi Arabia. Technol. ; RAY, D.; HALDAR, R.; BRZECZKO, A.W. (ed.). In general, the technology for making a matrix-type ibuprofen ODT formulation involved the use of special polymers, water-soluble excipients, super-disintegrants and quickly soluble granules. Mouth dissolving tablets: A novel drug delivery system. The ODTs were prepared by direct compression. The dissolution CL from ODT formulations F3, F6 and F9 (containing 5% each of CCS, SSG, and CPV, respectively) was studied in two different dissolution media, at pH 2.0 and pH 6.8 and the results are displayed in Figure 7. Pharma. ; SHAH, T.P. Gen. Although, all the in-vitro results of formulations F17a and F17b, except for hardness and friability, were within the acceptable but none of them had a desirable taste. formulated a solid dispersion of clopidogrel into fast dissolving tablets. (English), https://doi.org/10.1590/S1984-82502016000200009, This is an open-access article distributed under the terms of the Creative Commons Attribution License, Formulation and evaluation of orally disintegrating clopidogrel tablets. ; KUPPASAD, I.J. The calculated bulk density was between 0.39-0.44 g/cc and the tapped density was between 0.398B10.007 and 0.43-0.50 gm/cc for all tested powder blends. Stage 3 Lyophilization Pharm. Stay informed of issues for this journal through your RSS reader, Resumo RGP -299. For the corresponding physical mixtures of the drug with all of the additives except mannitol, the characteristic endothermic peak of the drug was seen in its melting range (184B13 oC), but with lower intensity (Figure 2). The DSC scan of untreated clopidogrel showed a characteristic endothermic peak at 184 B0C (Figure 1), which corresponds to its melting point. (ed.). In order to improve the taste of formulation F17, xylitol and aspartame were added extra-granularly and as a result series D formulations were made. There was a significant difference between the taste results of formulation F22a and series G and H formulations (Friedman test, p < 0.05). It can be concluded that the optimum concentration of superdisintegrant is 5%, which gave rapid disintegration of CL tablets. Such a formulation could be found as a practical technology for adaptation in the pharmaceutical industry. In another study, Zade et al. ; MUOZ-RUIZ, A.; JIMNEZ-CASTELLANOS, R. Disintegrating efficiency of croscarmellose sodium in a direct compression formulation. However, in this study super-disintegration method was found to be superior to that of sublimation method (11). After comparing their taste by considering the taste scores given by ten volunteers, formulation F22s was selected as the ultimate formulation. The direct compression technique was selected rather than wet granulation because the porous nature of tablets prepared by direct compression results in faster disintegration. Guidance for Industry. (2008BALASUBRAMANIAM, J.; BINDU, K.; RAO, V.U. Experiments were carried out in phosphate buffer (pH 6.8). Ibuprofen ODT formulations were prepared using quickly soluble granules. J. Adv. KUCCHERKAR, B.S. Potassium dihydrogen orthophosphate and Sodium hydroxide were purchased from Merck, Darmstadt, Germany. The results obtained from flowability (poor flow), compressibility (n = 10, mean standard deviation of 0.30 KP 0.05 with the highest compression force) and disintegration time of compacted powder (over 30 min) indicated undesirable characteristics. The physicochemical characteristics of different ibuprofen ODT formulations prepared including power/granule flowability, appearance, thickness, uniformity of weight, hardness, friability and disintegration time were investigated.

Quickly soluble granules were used alongside other formulation ingredients. The fibrous nature of CCS is more pronounced at lower concentrations and smoothens gradually with time.

Overall, all the physicochemical tests conducted on formulation F22s were found to be acceptable (particularly a disintegration time of 46 sec) and hence this formulation was chosen as the final formulation of this study. The in vitro dissolution profiles of CL from the prepared orally disintegrating tablets in the compendial medium (pH 2.0) are displayed in Figures 4-6. Todos os comprimidos possuC-am dureza na faixa de 4,0-5,2 kp e a friabilidade inferior a 1%. Then, by adding various flavorants and sweeteners to this formulation, complementary series of formulations, named G and H, were prepared. The bulk API is formulated into a liquid solution or suspension. Characterizes the API crystal form and identifies any changes during formulation and processing, Freeze-drying microscopy ; SOUKARYA, S.; UPENDER, S. Formulation and optimization of solid dispersion of Clopidogrel with PEG 6000. No additional peaks were observed in case of the physical mixture. Preparation and evaluation of mouth dissolving tablets of salbutamol sulphate. Although, numerous technologies had been developed for the fabrication of these unique dosage forms in the last two decades, but so far, no standardized technique has been designed or mentioned in the literature for their preparation and evaluation (18). The liquid is precisely filled into pre-formed blisters and passed through a specially designed cryogenic freezing process to control the ultimate size of the ice crystals. Each flask contained 500 mL 0.1N HCl, adjusted to pH 2.0 or phosphate buffer at pH 6.8 maintained at 37 B1 0.5 B0C. At predetermined time points (5, 10, 15, 20 and 30 minutes), a 5 mL sample was withdrawn and replaced with fresh dissolution medium. Decreasing the particle size increases the surface area, which leads to an increase in dissolution rate. 'rF: h7. The major problems existing in series B formulations, resulting in their rejection and preparation of series C formulations were low hardness and high friability as well as inappropriate disintegration time in most cases (7-11 min). These tablets are called fast dissolving tablets, orally disintegrating tablets (ODTs) or mouth-dissolving tablets. This technology uses drug, fillers and a lubricant to prepare the tablet. Formulations prepared were examined in terms of different physicochemical tests including powder/granule flowability, appearance, thickness, uniformity of weight, hardness, friability and disintegration time. Thermograms of the samples were obtained using differential scanning calorimetry (DSC-60, Shimadzu, Japan). Hence, for improving these characters, the use of appropriate ingredients and a suitable manufacturing method were necessary. J. government site.

In addition, there was no significant difference between the results of thickness and uniformity of weight in series B formulations (ANOVA, p > 0.05). IR spectra (Figure 3) of clopidogrel, mannitol and their physical mixture were recorded in order to determine whether there was a chemical interaction between them. Before Unitermos:Clopidogrel/comprimidos de desintegraC'C#o oral; Superdesintegrantes; Comprimidos/de desintegraC'C#o oral/formulaC'C#o; Comprimidos/de desintegraC'C#o oral/avaliaC'C#o. Recent technological advances in oral drug delivery: a review. Series C formulations, in which ibuprofen, croscarmellose and glucose were used intra-granularly; showed appropriate and acceptable results in terms of flowability, appearance of tablets (except for formulation F19), thickness, uniformity of weight and disintegration time. In the Wowtab technology the active ingredients may constitute up to 50% w/w of the tablet. The test was performed on CL containing tablets in triplicate. The study was approved by the King Saud University Ethics committee, Riyadh, Saudi Arabia. The frozen units are then transferred to large-scale freeze dryers for the lyophilization process. Recentes avanC'os em sistemas de liberaC'C#o de fC!rmacos novos visam C obtenC'C#o de melhor adesC#o do paciente. Hardness of formulations F20 and F20a was worse than F17. Suresh S, Pandit V, Joshi HP. Effect of superdisintegrants on dissolution of cationic drugs. The blends of the drug and various tablet excipients were evaluated for their micromeritic characteristics as shown in Table III. Pharmaceutics: The Science Of Dosage Form Design. sharing sensitive information, make sure youre on a federal Upon scanning the DSC thermogram of the drug-mannitol physical mixture, the drug fusion peak appeared at about 154 oC suggesting an interaction between the drug and mannitol. BIRADAR, S.S.; BHAGAVATI, S.T. These granules were made as follows: first of all polyethylene glycol 1000 was melted on a heater, then glucose or sucrose was added at room temperature under the action of a four-propeller mixer set at 50 rpm. MOSTAFA, H.F.; IBRAHIM, M.A. The drug content was determined spectrophotometrically at 240 nm (Ashraf Z. et al. (English), Resumo Also, formulations F7 and F8 were too sticky to measure their flowability and compressibility. Thereafter, the formula weight of mannitol was mixed with the MCC-superdisintegrant mixture for 10 min. In order to study qualitative data (taste studies), Friedman and Wilcoxon paired statistical tests were used. Int. The data were analysed using Perkin Elmer software (Spectrum V5.3.1). J. Thus, the obtained results conclusively demonstrated successful rapid disintegration of the formulated tablets and acceptable palatability. The The authors explained their results on the basis that of the commonly used superdisintegrants, crospovidone is nonionic, while SSG and croscarmellose sodium are anionic. Khawla A, Vincent L, Jee L, Graham P, Matthew S. The United States Pharmacopoeia and National Formulary. The results of taste studies (1 = best and 5 = worst) conducted on series F, G and H ibuprofen ODT formulations (n = 10; Mean SD). Os comprimidos preparados foram avaliados quanto C dureza, C friabilidade, ao tempo de desintegraC'C#o e C liberaC'C#o do fC!rmaco in vitro. Um destes avanC'os C) a formulaC'C#o de comprimidos de desintegraC'C#o oral (ODTs), que se dissolvem instantaneamente, liberando o fC!rmaco, em alguns segundos, sem a necessidade de C!gua. This observation was in agreement with the higher disintegration times expected with such formulas. Various formulations were prepared using different ingredients in eight series (A-H), and physicochemical properties of each series including flowability, appearance, thickness, uniformity of weight, hardness, friability and disintegration time were investigated.

N2 was used as the purging gas at a rate of 30 mL/min. This goal can be accomplished predictably and efficiently using the Nanocrystal technology. ; SOUKARYA, S.; UPENDER, S. Formulation and optimization of solid dispersion of Clopidogrel with PEG 6000. This formulation was studied in terms of physicochemical tests conducted on the previous formulations, as well as the assay of active ingredient. It is clearly evident from the data that the superdisintegrants used caused a pronounced decrease in the disintegration time of the prepared ODTs, especially CCS and CPV. The Hausner ratio was found to be below 1.15.

ODTs have also been recently used in animals (6). Ibuprofen is an effective and widely used non-steroidal anti-inflammatory drug, with an extensive use in adults and children for relief of pain, fever and inflammation. The https:// ensures that you are connecting to the and transmitted securely. All these physicochemical tests were conducted in the standard way (5, 21, 24, 25), except for the disintegration time. The aim of the present work was to prepare fast disintegrating clopidogrel tablets by direct compression and to study the effect of the type and concentration of the superdisintegrant used on the physical properties of the prepared tablets, as well as on drug dissolution and disintegration. ; 2015ASHRAF, Z.; KHURRAM, S.; MAQBOOL, U.; KHAN, K.R. Pharm. Uniterms:Clopidogrel/orally disintegrating tablets; Superdisintegrants; Orally disintegrating tablets/formulation; Orally disintegrating tablets/evaluation. Tech., v.18, n.2, p.454-463, 2013.). Vol. Therefore, in series E formulations, in order to improve the taste, alcohol was substituted by water in the polyvinyl pyrrolidone solution. Dissol.

MOSTAFA, H.F.; IBRAHIM, M.A. Ansels Pharmaceutical Dosage Forms and Drug Delivery Systems. Quickly soluble granules of series A formulations included two parts. Eight groups of formulation were prepared (A-H series), accounting for a total number of 45 formulations. The blisters containing the dried Zydis units are then sealed via a heat-seal process to protect the product from varying environmental conditions and ensure long-term stability. An ODT formulation should disintegrate or dissolve in water quickly. Ibuprofen powder was purchased from Biocause Co. (Japan). Pharm. Accessibility Fast dissolving drug delivery systems: a brief overview. Technol. The use of ODTs could help to reduce the gastrointestinal side effects of ibuprofen, since the tablet is disintegrated within the mouth (13-15). In series C formulations, ibuprofen, croscarmellose and glucose were used together in the granules. Times, v.35, p.3-10, 2003. Series G and H ibuprofen ODT formulations.

; RAY, D.; HALDAR, R.; BRZECZKO, A.W. 52 In evaluation of mouth feel, eight of the volunteers reported that it was acceptable while the other two exhibited taste responses with no complaints of numbness. In this series of formulations, the flowability of formulation F17b was better than formulation F17a and there was a significant difference between the results obtained (t-test, p < 0.05). Sci. A sugar based matrix, called Floss is used, which is made up of a combination of excipients (crystalline sugars) alone or in combination with drug. In a previous study, Sahitya et al. Iranian Journal of Pharmaceutical Research : IJPR, http://creativecommons.org/licenses/by/3.0/. Therefore, formulation F17 was chosen as the selected ODT formulation among the formulations prepared, with a disintegration time of 5 sec. Mean hardness of series F ibuprofen ODT formulations (n = 10). Regarding the results obtained from the disintegration time, there was a significant difference between formulations F17a and F17b (t-test, p < 0.05) and also formulations F17a and F17 (t-test, p < 0.05). DEPARTMENT OF HEALTH AND HUMAN SERVICES. Alcohol 96% was supplied by the Parsian Shiraz Co. (Iran). New York: Marcel Dekker, 1989. v.1, p.131-94,). Series G and H complementary formulations were made by the addition of various flavorants and sweeteners to formulation F22a. For the purpose of statistical comparison of the results obtained, students t-test was used in the cases where two samples were compared and the two-tailed ANOVA test in cases where over two samples were compared. ; SOUKARYA, S.; UPENDER, S. Formulation and optimization of solid dispersion of Clopidogrel with PEG 6000. It is a unique freeze-dried tablet in which the active drug is incorporated within a water-soluble matrix, which is then transformed into blister pockets and freeze dried to remove water by sublimation. Preparation of complementary formulations and taste masking. To v.3, p.138-145, 2003.).

This test was performed at room temperature. Samples (3-5 mg) were weighed and hermetically sealed in aluminium pans and heated at a constant rate of 10 B0C/min, in a temperature range from 25 B0C to 250 B0C. BANDELIN, F.J. Compressed tablets by wet granulation. Mean disintegration time of series F ibuprofen ODT formulations (n = 6). (ed.).

In conclusion, ODTs of CL were developed that had sufficient mechanical integrity, and uniformity of content with acceptable palatability to allow easy administration to patients of any age group. Tech., May, p.18-25, 2008. Bethesda, MD 20894, Web Policies There are some disadvantages to these technologies. Asian J. Fast dissolving drug delivery systems: a brief overviewInt. W. J. Pharm. ; SAKR, A. The technologies utilized for fabrication of ODTs include lyophilization, moulding, direct compression, cotton candy process, spray drying, sublimation, mass extrusion, nanonization and quick dissolve film formation. Then, the beaker was placed on a shaker with a speed of 30 rpm, for imitation of lightly flow of saliva. In vitro disintegration tests and in vitro drug release studies of ODTs tablets showed a fast disintegration within seconds at pH 6.8 and more than 90% of the drug was released within 5 minutes in acidic medium. Pharm. Following the comparison of their taste with each other through asking 10 volunteers, the most suitable formulation regarding the taste, being formulation F22s, was chosen as the ultimate formulation. Formulations administered via the oral route represent 50-60% of the total pharmaceutical dosage forms in the market (Bandelin, 1989BANDELIN, F.J. Compressed tablets by wet granulation. The weight and drug content uniformity of all formulations was within official limits according to BP. SAHITYA, A.; KRISHNAMOORTHY, B.; MUTHUKUMARAN, M.; KISHORE, G. Formulation and evaluation of fast dissolving tablets using solid dispersion of clopidogrel bisulphate. (ed.). Shafaati AR, Clark BJ. The first series of formulations (series A) contained polyethylene glycol 1000, glucose or sucrose as the intra-granular part of formulation and ibuprofen, croscarmellose, magnesium stearate and silicone dioxide as the extra-granular part.

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