scholarly journals FORMULATION AND EVALUATION OF ORODISPERSIBLE TABLETS (ODTS) OF DICLOFENAC SODIUM BY USING SUPERDISINTEGRANT FROM NATURAL ORIGIN

Author(s):  
SATYAJITH PANDA ◽  
NODAGALA HEMALATHA ◽  
PANCHAGNULA UDAYA SHANKAR ◽  
SRINIVASA RAO BARATAM

Objective: In this study, a polysaccharide isolated from the seeds of Cajanus cajan (pigeon pea) was investigated as a super disintegrant in the orodispersible tablets of diclofenac sodium. Methods: Diclofenac sodium tablets were prepared separately using different concentrations (5%, 7.5%, 10%, and 15% w/w) of isolated Cajanus cajan seed polysaccharide (natural) and sodium starch glycolate (synthetic) as super disintegrant by the direct compression method. Evaluation of tablets was done for various pre-and post-compression parameters. The stability studies were performed on optimized formulation F5. The disintegration time and in vitro drug release of the formulation F5 was compared with pregelatinized starch and synthetic super disintegrant (sodium starch glycolate). Results: The drug-excipient interactions were characterized by Fourier transform infrared studies. The Optimized formulation F5 containing 15% polysaccharide showed wetting time of 118.7 seconds with 105.3 seconds of disintegration time and 95.61% dissolved in 3 min. Conclusion: The present work revealed that Cajanus cajan seed polysaccharide has a good disintegrating agent in the formulation of orodispersible tablets.

Author(s):  
SONIA DHIMAN ◽  
RITCHU BABBAR ◽  
THAKUR GURJEET SINGH ◽  
SHIVANGI ANAND ◽  
ASHI MANNAN ◽  
...  

Objective: The aim of the research work was to explore the use of Cajanus cajan (Pigeon pea) polysaccharide as a superdisintegrant. The novel superdisintegrant has been evaluated for its action by incorporating it into orodispersible tablets of Metformin Hydrochloride. Methods: Cajanus cajan starch was extracted from its seeds and superdisintegrant was developed by microwave modification of the extract. Various characterization tests such as gelatinization temperature, water absorption index, pH, and viscosity were used to identify the microwave-modified polysaccharide. The orodispersible tablets were made using a direct compression process employing varying concentrations of modified Cajanus cajan starch. Prepared tablets were tested for several pre and post-compression parameters and compared with a well-established synthetic superdisintegrant, sodium starch glycolate. The stability studies were conducted on an optimized formulation. Results: Fourier transform infrared spectroscopy study showed that the drug had no interactions with the microwave-modified Cajanus cajan starch. SEM confirmed that Cajanus cajan starch granules exhibited intact granular structure in oval shapes and smooth surfaces. After microwave modification, the Cajanus cajan starch component lost its granular structure, which further led to the generation of surface pores and internal channels, causing overall swelling responsible for superdisintegrant activity. The optimized formulation (ODF5) containing 15 % modified Cajanus cajan starch performed better in terms of wetting time (22.21 s), disintegration time (53.3 s), and in vitro drug release (92%), as compared to formulation prepared by synthetic superdisintegrant (ODF1). Conclusion: The present investigation concluded that modified Cajanus cajan starch has good potential as a superdisintegrant for formulating oro-dispersible tablets. Furthermore, modified Cajanus cajan starch is inexpensive, non-toxic and compatible in comparison with available synthetic superdisintegrants.


Author(s):  
Dattatraya M. Shinkar ◽  
Pooja S. Aher ◽  
Parag D. Kothawade ◽  
Avish D. Maru

Objective: The main objective of this research work was to formulate and evaluate fast dissolving tablet of verapamil hydrochloride for the treatment of hypertension.Methods: In this study, fast dissolving tablet were prepared by wet granulation method by using croscarmellose sodium and sodium starch glycolate as superdisintegrants in the concentration of 2%, 4%, and 6%. Polyvinyl pyrollidone K30 is used as a binder. The designed tablets were subjected to various assessment parameters like friability test, hardness test, disintegration test, wetting time, in vitro drug release and drug content.Results: All the prepared formulations were subjected to various assessment parameters, and the findings obtain within the prescribed limit. The calibration curve of pure drug using various solvents like distilled water, phosphate buffer pH 6.8 was plotted. F1-F9 containing croscarmellose sodium and sodium starch glycolate in various concentration demonstrate the minimum disintegration time. Among all these formulations F8 shows disintegration time upto 19±0.06 seconds due to the high concentration of superdisintegrants. In vitro drug release was tested in phosphate buffer pH 6.8 at a time interval of 0, 1, 3,6,9,12,15 min. The F8 shows drug release 98.5±0.567%. Accelerated stability study of optimized formulation (F8) up to 2 mo showed there was no change in disintegration time and percentage drug release.Conclusion: The results obtained in the research work clearly showed a promising potential of fast dissolving tablets containing a specific ratio of crosscarmellose sodium and sodium starch glycolate as superdisintegrants for the effective treatment of hypertension. 


2015 ◽  
Vol 49 (3) ◽  
pp. 173-180
Author(s):  
T Ayyappan ◽  
C Poojitha ◽  
T Vetrichelvan

In the present work, orodissolving tablets of Efavirenz were prepared by direct compression method with a view to enhance patient compliance. A 23 full factorial design was applied to investigate the combined effect of three formulation variables. Amount of crospovidone, croscarmellose sodium and sodium starch glycolate were used as superdisintegrant material along with direct compressible mannitol to enhance mouth feel. The prepared batches of tablets were evaluated for hardness, friability, weight variation, disintegration time, wetting time, drug content and in-vitro dissolution studies. Based on wetting time, disintegration time, the formulation containing crospovidone (5% w/v), carscarmellose sodium (5% w/v) and sodium starch glycolate (8% w/v) was found to be promising and tested for in-vitro drug release pattern (in 0.1 N HCl), short term stability and drug- superdisintegrants interaction. Surface response plots are presented to graphically represent the effect of independent variables (conc. of superdisintegrants) on the in-vitro dissolution time. The validity of the generated mathematical model was tested by preparing extra-design check point formulation. The formulation showed nearly faster drug release compared to the conventional commercial tablet formulation. Stability studies on the optimized formulation indicated that there was no significant change found in physical appearance, hardness, disintegration time, drug content and in-vitro drug release. DOI: http://dx.doi.org/10.3329/bjsir.v49i3.22131 Bangladesh J. Sci. Ind. Res. 49(3), 173-180, 2014


Author(s):  
MEGHAWATI R. BADWAR ◽  
SANDHYA L. BORSE ◽  
MANISH S. JUNAGADE ◽  
ANIL G. JADHAV

Objective: The main objective of this research work was to formulate and evaluate the mouth dissolving tablet of amlodipine besylate for the treatment of hypertension and coronary artery disease. Methods: In this study, mouth dissolving tablet were prepared by direct compression method by using croscarmellose sodium and sodium starch glycolate as superdisintegrants. The designed tablets were subjected to various assessment parameters like friability test, hardness test, disintegration test, wetting time, in vitro drug release and drug content. Results: All the prepared formulations were subjected to various assessment parameters, and the findings obtain within the prescribed limit. The calibration curve of pure drug using various solvents like phosphate buffer pH 6.8, methanol was plotted. F1-F9 containing croscarmellose sodium and sodium starch glycolate in various concentration demonstrate the minimum disintegration time. Among all these formulations F9 shows disintegration time up to 22±1.12 seconds due to the high concentration of superdisintegrants. In vitro drug release was tested in phosphate buffer pH 6.8 at a time interval of 0, 1, 2, 3, 4, 5 min. The F9 shows drug release 100.22±1.08%. Accelerated stability study of optimized formulation (F9) up to 2 mo showed there was no change in disintegration time and percentage drug release. Conclusion: The results obtained in the research work clearly showed a promising potential of mouth dissolving tablets containing a specific ratio of croscarmellose sodium and sodium starch glycolate as superdisintegrants for the effective treatment of hypertension and coronary artery disease.


2021 ◽  
Vol 11 (1) ◽  
pp. 60-64
Author(s):  
Rishabh Bindal ◽  
Arpna Indurkhya

Due to more versatility and comfort, mouth dissolving tablets are the most advanced type of oral solid dosage forms. Compared to conventional tablets, it increases the effectiveness of APIs by dissolving within a minute in the oral cavity after contact with less saliva, without chewing and without the need for water for administration. Mouth Dissolving Tablets of Ketorolac tromethamine were prepared by direct compression method using various superdisintegrants like crospovidone, Croscarmellose sodium, and Sodium starch glycolate in different concentrations. Prepared tablets were evaluated for hardness, friability, weight variation, disintegration time, wetting time and in vitro drug release. Results of pre-compression and post-compression studies of all formulations were found within the standard limits. The tablets of all the batches were found to release more than 80% of drug in 5 minutes, which is the desired quality of mouth dissolving tablets that helps in faster absorption of the drug and quick onset of therapeutic effect. The the order of dissolution of various disintegrants was found to be Crospovidone˃ SSG˃ CCS. There was no significant variation in drug content of drug during stability studies for selected batch F3 in accelerated conditions over three months. It was concluded from the study that fast release of Ketorolac tromethamine from formulation F3 may reduce onset of drug action with better patient compliance. Keywords: Crospovidone, Croscarmellose sodium, Ketorolac tromethamine, Mouth dissolving tablets, Sodium starch glycolate, superdisintegrants.


2015 ◽  
Vol 05 (01) ◽  
pp. 040-044
Author(s):  
D S Sandeep ◽  
R Narayana Charyulu ◽  
Prashant Nayak

AbstractIn the present investigation comparison of three different superdisintegrants was carried out by formulating orally disintegrating tablets. Promethazine HCl was used as model drug which is an antiemetic drug. Sodium starch glycolate, croscarmellose and crospovidone were selected as superdisintegrants and each one was used in three different concentrations (2%, 3.5% and 5%). The drug-polymer compatibility was ruled out by FTIR studies. A total of nine formulations (PF1-PF9) were made by direct compression. All prepared formulations were evaluated for weight variation, hardness, friability, drug content, disintegration time, wetting time and in vitro drug release parameters. The results of the evaluation parameters for all the nine formulations of promethazine HCl were within the standard limits. The in vitro drug release for promethazine HCl tablets of all the formulations (PF1-PF9) was carried out using phosphate buffer pH 6.8 as dissolution medium. Among all the formulations the tablets formulated with crospovidone (PF7-PF9) have shown 91.43 - 98.43% (maximum) drug release at the end of 10 min than sodium starch glycolate and croscarmellose, hence from the present work, it concluded that among three superdisintegrants crospovidone is the ideal superdisintegrant for formulating oral disintegrating tablets for promethazine HCl.


Author(s):  
P. V. KAMALA KUMARI ◽  
Y. SRINIVASA RAO

Objective: The present study was aimed to develop the formulation and in vitro evaluation of Orodispersible tablets by wet granulation method using Donepezil HCl as a model drug to enhance patient compliance. Methods: In the wet granulation method, a mixture of microcrystalline cellulose and hydroxypropyl methylcellulose were used along with superdisintegrants, i.e., croscarmellose sodium and crospovidone. The prepared granules were subjected to both pre and post-compression evaluation parameters including; FTIR spectroscopy, micromeritics properties, tablet weight variation, hardness, friability, drug content, disintegration time and in vitro drug release. Results: FTIR studies indicated that there was nointeraction between the drug and the excipients used. The formulation containing high concentration of crospovidone and mixture as the best formulation F2 based on in vitro drug release characteristics of tablet formulation. Conclusion: The results of this work suggested that orodispersible tablets of Donepezil hydrochloride with rapid disintegration time, fast drug release and good hardness can be efficiently and successfully formulated by wet granulation method.


Author(s):  
NIRMALA DASARI ◽  
VIDYAVATHI MARUVAJALA

Objective: The objective of the present work was to prepare an optimized, fast dissolving tablet (FDT) of Pitavastatin to increase its dissolution by applying 32full factorial design. Methods: Nine formulations (PF1 to PF9) with all possible combinations according to 32full factorial design by selecting two factors i.e. concentration of super disintegrant, Indion414 (5-15%) (A) and sublimating agent, camphor (40-60%) (B) as independent variables at three levels of-1, 0 and 1. The effect of these two variables on three dependent parameters, water absorption ratio (Y1), disintegration time (Y2) and in vitro drug release (Y3) was studied. All the powder blends were evaluated for precompression parameters, and the tablets were prepared by direct compression method which were further evaluated for post-compression parameters. The effect of change in concentration of two selected factors on dependent parameters was studied through 3D surface response plots and polynomial equations using Design expert software version11. Optimized formula was obtained by desirability and overlay plots for which compatibility stability was assessed. Results: Precompression and post-compression parameters were satisfactorily within acceptable limits. Optimized formulation was prepared to prove the validity of the evolved mathematical model, which contained 6.75 mg of indion414(0.9) and 54 mg of camphor(0.9) with a disintegration time of 21 sec., water absorption ratio of 113 and 93% of drug release within 12 min. The compatibility between drugs and excipients was proved. The dissolution profiles of optimized formulation and commercially available conventional film-coated tablets of Pitavastatin were compared. Conclusion: The optimized formulation showed significantly (P>0.05) increased drug release compared to commercially available film-coated tablets. No changes in disintegration time, drug content and in in vitro drug release from optimized formulation on storage for 3months at 40 °C±2 °C/75% RH±5% RH were observed during stability studies which confirmed the stability of the optimized formulation.


INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (12) ◽  
pp. 60-62
Author(s):  
P. Jain ◽  
◽  
A Mishra ◽  
A. Pathak

Orodispersible tablets are uncoated tablets which when taken into the mouth, get easily dispersed within 3 min before swallowing. they are also known as orally disintegrating tablets, mouth-dissolving tablets, rapid dissolving tablets fast-disintegrating tablets, fast-dissolving tablets. In this work, sublimation process was used to prepare orodispersible tablets of aspirin by formulating various batches using different concentration of sodium starch glycolate, camphor and cross povidone. An effort was made by using two modes, first, to increase water uptake for the fast dispersion by creating pores by sublimation methods in tablets and second, use of super disintegrantes like sodium starch glycolate to minimise disintegration time and promote fast dispersing ability. Prepared formulations were evaluated for weight variation, content uniformity, friability, hardness, wetting time, disintegration time, in vitro drug release and interaction study by differential scanning calorimetery. The best formulation was selected on the basis of evaluation results.


Author(s):  
Reecha Madaan ◽  
Rajni Bala ◽  
Tejeswini Vasisht ◽  
Ritima Sharma ◽  
Shivali Garg

Objective: The present research work was to formulate matrix tablets of diclofenac sodium using mucilage extracted from Tinospora cordifolia as a novel binding agent. Also, a comparative study on binding properties of mucilage and carbopol were performed.Methods: Fresh stems of Tinospora cordifolia were collected and mucilage was extracted out using standard method. The isolated mucilage was characterised for physicochemical parameters. Formulation of diclofenac sodium tablets (f1-f6) was done by dry granulation method using 2%, 4%, 6%, 8% and 10% concentration of mucilage of Tinospora cardifolia as natural binder. Carbopol 2% was used as synthetic matrix forming agent. Microcrystalline cellulose was used as diluents, magnesium stearate and talc as lubricant. The formulated tablets were evaluated for parameters such as tablet thickness, hardness, weight variation, disintegration time, percent friability and in vitro drug release characteristics. The drug release mechanism was determined by fitting the release data into different kinetics models.Results: The results revealed that all the pre and post compression parameters of the formulated tablets (f1-f6) were in compliance with pharmacopoeial limits. In vitro drug release studies showed that formulation f6 containing maximum concentration of mucilage release the drug in a most controlled and sustained manner with maximum drug release of 63.6% in 15 h in comparison with f1(2% carbopol) giving 80% release and was found to be stable for 3 mo as indicated by stability studies. The mechanism of drug releases from formulation f1-f6 was found to be polymer disentanglement and erosion. Preformulation studies using FTIR study reveals that there is no incompatibility between the pure drug and mucilage of tinospora cardifolia used.Conclusion: Based on the experimental findings it can be concluded that Tinospora cordifolia mucilage can be used as a release retardant agent in the formulation of sustained release dosage forms.


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