Evaluation of two novel co-processed excipients for direct compression of orodispersible tablets and mini-tablets

Author(s):  
Marcel Kokott ◽  
Ard Lura ◽  
Jörg Breitkreutz ◽  
Raphael Wiedey
2016 ◽  
Vol 27 (1) ◽  
pp. 58-61
Author(s):  
Valeriu Iancu ◽  
Florentina Roncea ◽  
Radu George Cazacincu ◽  
Dumitru Lupuleasa

Abstract Orally disintegrating tablets (ODTs) are dosage forms which disintegrate in mouth within seconds without need of water. This type of quality in dosage form can be attained by addition of different varieties of excipients. Pharmaburst™ 500 is a co-processed excipient system which allows rapid disintegration and low adhesion to punches. The aim of the present study was to develop and evaluate 25 mg diclofenac sodium ODTs (orodispersible tablets) batches by direct compression method at different compression forces 10 kN (F1) and 20 kN (F2) and directly compressible excipients used in different ratio (Avicel PH 102, magnesium stearate and coprocessed excipient Pharmaburst™ 500, 70% and 80% w/w). The obtained batches were analyzed for appearance, tablet thickness, uniformity of weight, hardness, friability, disintegration time, and non-compendial methods (wetting time). Co-processed Pharmaburst™ 500 excipient 70% used for sodium diclofenac ODT obtaining determined good results for quality control tests evaluation.


2020 ◽  
Vol 19 (5) ◽  
pp. 919-925
Author(s):  
Durgaramani Sivadasan ◽  
Muhammad Hadi Sultan ◽  
Osama Madkhali ◽  
Shamama Javed ◽  
Aamena Jabeen

Purpose: To develop orodispersible tablets (ODTs) of fexofenadine hydrochloride using three different superdisintegrants in various ratios and to compare their disintegration properties.Methods: Direct compression technique was used for the preparation of ODTs. Mannitol and Avicel CE-15 (microcrystalline cellulose and guar gum) were used as direct compression diluents. The disintegration time of tablets using each polymer (superdisintegrant) was evaluated as well as othertablet properties including weight fluctuation, hardness, friability, wetting time and water absorption ratio.Results: Satisfactory values were obtained for all the evaluated parameters. As the polymer concentration increased, there was a decrease in disintegration time. A comparison of the three different polymers used revealed that CCM3 formulated with 12 % croscarmellose sodium and 14.66 % lactose had the least disintegration time of 32.33 ± 3.23 s. In vitro release studies showed that the maximum drug release of 94.38 ± 0.12 % in 25 min was obtained for ODT tablets containing croscarmellose sodium (CCM3).Conclusion: The orodispersible tablets had quick disintegrating property which was achieved using superdisintegrants. Thus, superdisintegrants improve the disintegration efficiency of orodispersible fexofenadine tablets at low concentrations, when compared to traditional disintegrants. Keywords: Croscarmellose sodium, Direct compression, Fexofenadine, Orodispersible tablets


2013 ◽  
Vol 4 (7) ◽  
pp. 123-130 ◽  
Author(s):  
B Sree Giri Prasad ◽  
V R M Gupta ◽  
N Devanna ◽  
N Siva Subramanian ◽  
CH Naveen Kumar ◽  
...  

Author(s):  
Johnny Edward Aguilar ◽  
Encarna García Montoya ◽  
Pilar Pérez Lozano ◽  
Josep M. Suñe Negre ◽  
Montserrat Miñarro Carmona ◽  
...  

2007 ◽  
Vol 17 (3) ◽  
pp. 199-203 ◽  
Author(s):  
L. Segale ◽  
L. Maggi ◽  
E. Ochoa Machiste ◽  
S. Conti ◽  
U. Conte ◽  
...  

2020 ◽  
Vol 12 ◽  
Author(s):  
Inderbir Singh ◽  
Ajay Kumar Thakur ◽  
Rajni Bala ◽  
Reecha Madan

Background: SeDeM (Sediment Delivery Model) expert system is a preformulation tool employed for evaluating direct compression suitability of various excipients. SeDeM is a 12 parameter and SeDeM-ODT (Sediment Delivery Model-Orodispersible tablets) is a 15 parameter derived diagram that can be used as a research tool for reducing the product development time. Best possible excipients for a specified pharmaceutical active ingredient could be screened for direct compression suitability. Objective: SeDeM expert system has been successfully used and implemented for characterizing galenic properties of pharmaceutical excipients, direct compression suitability of excipients, development of ODT formulations, development of sustained release formulations and development of tablets of taste masked drugs. Conclusion: In the present review paper development and applications of SeDeM and SeDeM-ODT systems have been discussed in detail.


Author(s):  
Akiladevi D

Objective: The objective of the existing research was to develop an oral disintegrating dissolving system as one of the taste masking orodispersible forms together of trazodone hydrochloride tablets using direct compression technique through the use of superdisintegrants together with FlowLac, StarLac, and sodium starch glycolate. Methods: The tablets were formulated using the direct compression approach. The drugs prepared have been evaluated for diverse parameters which include hardness, friability, weight variation, drug content uniformity, water absorption ratio, in vitro drug release, and wetting time. Results: The hardness of all formulations from F1 to F7 proved that the tablet means thickness was nearly uniform in all formulations with the range of 0.520 mm–0.522 mm. Water absorption of prepared formulations was found to be 68.59%–73.21%. Bulk density, tapped density, and friability of the formulations were established within the limits, results of in vitro drug release study showed the drug released between 90.27% and 96.17% at 60 min. Conclusion: The overall study concluded that orodispersible tablets of trazodone hydrochloride have greater dissolution rate and will result in enhanced bioavailability. The taste masked systems are designed to provide better acceptability, improved bioavailability, for chronic patients. The study results revealed that the formulation F6 was contemplated as the top formulation.


Author(s):  
RAJASEKHAR POONURU ◽  
ROHINI CHERUKU ◽  
PAVAN JULURI ◽  
KHADEERA JABEEN ◽  
SWETHA SREERAMULA ◽  
...  

Objective: The present study was designed to formulate and evaluate the orodispersible tablets of lamotrigine after enhancing its solubility. Methods: Lamotrigine was made into an inclusion complex with eudragit E 100 my kneading and mass extrusion method and later this mixture is compressed into orodispersible tablet using various super disintegrants and co-processed excipients to reduce the disintegration time for providing prompt action through rapid drug release. Results: Lamotrigine ODTs containing F-melt (F1-3%, F2-5%) dispersed in lesser time of (9±0.11) and (21±0.58) compared to formulations with polyplasdone XL-10 and primellose as super disintegrants respectively with F1 showing short wetting time. The water absorption was also was found to be more for formulation with 3% F-Melt. Conclusion: Lamotrigine orodispersible tablets were prepared by direct compression technique by using 3% and 5% of three super disintegrants (f-melt, primellose and polyplasdone XL-10). Disintegration time of F1 (3% f-melt) formulation was found to be least (7 sec).


Author(s):  
S. P. Hiremath ◽  
Chidambar Makanapur

Objective: The rationale of the current work was to formulate and evaluate orodispersible tablets by direct compression technique with a vision to augment patient compliance and rapid onset of action.Methods: Nine orodispersible formulations of propranolol were formulated by direct compression method using sodium starch glycolate, crospovidone and croscarmellose sodium as the super disintegrants. The prepared formulations were evaluated for wetting time, drug content, in vitro disintegration time, dispersion time, dissolution time and also projected to kinetic treatment to know the pattern of drug release. Further, the discovered promising formulation was subjected to stability studies.Results: Based on the results obtained, formulation F9 containing6 mg of croscarmellose sodium exhibited good wetting time, dispersion time, and disintegration time and drug release compared to orodispersible tablets prepared with other super disintegrants. The stability studies piloted as per International Conference on Harmonisation guidelines on the promising formulationF9disclosedno significant changes in the colour (white), drug content (94.87±0.141 mg), hardness (2.93±0.18 kg/cm2), disintegration time (17.11±0.089 s), and drug release after 4 w. After 60 s, the percentage drug release of F9 was found to be 98.52 % and 96.30 % after 1 and 4 w, respectively.Conclusion: Orodispersible tablets of propranolol hydrochloride were formulated successfully by employing direct compression technique. From the investigation, it can be reasonably concluded that F9 batch orodispersible tablets of propranolol with 6 mg of crospovidone exhibited maximum cumulative drug release in 60 s.


2019 ◽  
Vol 7 (3) ◽  
pp. 46-53
Author(s):  
Anupam Kumar Sachan

Objective: The main objective of this study is comparative study of natural and synthetic superdisintegrants in orodispersible Metformin tablet by using direct compression method and wet granulation method. Method: Orodispersible Metformin tablet were prepared by wet granulation method and direct compression method by using different synthetic and natural superdisintegrants. Orodispersible tablets (ODTs) have received more interest in the pharmaceutical industry for their easy to use and self medication. ODTs overcome the problem of dysphagia (difficulty in swallowing) in the all group age of patients and advantage particularly for the paediatric and geriatric patients. Metformin hydrochloride (Hcl) is an orally administered antihyperglycemic agent, used in the management of non-insulin dependent (type-2) diabetes mellitus. Metformin orodispersible tablet is prepared by using two methods i.e. direct compression method and wet granulation method. Both methods are applied to prepare Orodispersible Metformin tablet. Orodispersible tablet of Metformin was prepared by using superdisintegrants from both natural and synthetic origin. In natural superdisintegrants we used the mucilage of Fenugreek and Lepidium sativum. In synthetic superdisintegrants we used crospovidone and sodium starch glycolate. Conclusion: In direct compression and wet granulation method final blend and granules were evaluated the flow properties like bulk density, tapped density, compressibility index, hausner’s ratio and angle of repose. The values of precompression parameter evaluated were found to be within the prescribed limit and indicated good flow properties. The data obtained from the post compression methods was studied. Other parameters such as wetting time, water absorption ratio were also evaluated. The formulation (F5) containing 10% crospovidone prepared by wet granulation method was found the optimize formulation. Keywords: Metformin Hcl, Orodispersible tablets, Superdisintegrants, Direct Compression, and Wet granulation Objective: The main objective of this study is comparative study of natural and synthetic superdisintegrants in orodispersible Metformin tablet by using direct compression method and wet granulation method. Method: Orodispersible Metformin tablet were prepared by wet granulation method and direct compression method by using different synthetic and natural superdisintegrants. Orodispersible tablets (ODTs) have received more interest in the pharmaceutical industry for their easy to use and self medication. ODTs overcome the problem of dysphagia (difficulty in swallowing) in the all group age of patients and advantage particularly for the paediatric and geriatric patients. Metformin hydrochloride (Hcl) is an orally administered antihyperglycemic agent, used in the management of non-insulin dependent (type-2) diabetes mellitus. Metformin orodispersible tablet is prepared by using two methods i.e. direct compression method and wet granulation method. Both methods are applied to prepare Orodispersible Metformin tablet. Orodispersible tablet of Metformin was prepared by using superdisintegrants from both natural and synthetic origin. In natural superdisintegrants we used the mucilage of Fenugreek and Lepidium sativum. In synthetic superdisintegrants we used crospovidone and sodium starch glycolate. Conclusion: In direct compression and wet granulation method final blend and granules were evaluated the flow properties like bulk density, tapped density, compressibility index, hausner’s ratio and angle of repose. The values of precompression parameter evaluated were found to be within the prescribed limit and indicated good flow properties. The data obtained from the post compression methods was studied. Other parameters such as wetting time, water absorption ratio were also evaluated. The formulation (F5) containing 10% crospovidone prepared by wet granulation method was found the optimize formulation. Keywords:


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