scholarly journals THE THE METHOD OF RANDOM BALANCE FOR STUDYING THE INFLUENCE OF EXCIPIENTSʼ QUANTITIES ON TECHNOLOGICAL PARAMETERS OF METFORMIN ORODISPERSIBLE TABLETS

Author(s):  
MARIANA DEMCHUK ◽  
MARIANA CHUBKA ◽  
TARAS HROSHOVYI

Objective: The present investigation was undertaken with an objective of analyzing the influence of excipientsʼ amount on the technological parameters of metformin orodispersible tablets using the method of random balance. Methods: The tablets were prepared by using direct compression method. The formulations were designed according to the method of random balance. The technological parameters of metformin orodispersible tablets have been studied as a function of quantitative factors: crospovidone (Polyplasdone XL-10®), magnesium aluminometasilicate (Neusilin US2®), microcrystalline cellulose (MCC Sanaq® burst), lactose monohydrate, magnesium stearate (Tablube® MgSt micronized vegetable) and talc.    Results: The flowability results were ranging from excellent to good according to the quantities of Neusilin US2® and Polyplasdone XL-10® crospovidone, which used. Results of bulk density and tapped density of the powder mixtures for pressing depended from the quantities of Neusilin US2® and talc. The obtained tablets had uniform weight from 0.93 to 2.30 %. The increase in the amount of Polyplasdone XL-10® crospovidone and the decrease in the amount of talk improved the uniformity of tablets’ weights. All of the prepared tablets showed acceptable hardness and friability which were improved with decrease in the amount of MCC Sanaq®burst and increase in the amount of Neusilin US2®. The rapid disintegration and wetting time for all formulations of tablets were obtained by using the Polyplasdone XL-10® crospovidone and MCC Sanaq®burst.  Conclusion: Oral disintegrating tablets of metformin were successfully prepared by direct compression method. The random balance method enabled us to identify the most significant quantitative factors and stabilize them at optimal values.

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.


2021 ◽  
pp. 35-42
Author(s):  
O. I. Hordiienko ◽  
T. A. Hroshovyi

The available range of phytopreparations for topical use in the oral cavity does not fully meet the needs of patients as mainly medicinal plant raw materials and tinctures of domestic production represent it. Therefore, we developed a pharmaceutical composition in the form of tablets based on dry extracts herb of Geranium sanguineum L., Geranium sibiricum L. and essential oil of Salvia sclare. To optimize the composition of the tablets it is necessary to study and select the necessary excipients and their quantities, which was the purpose of the work. In order to study the influence of 10 quantitative factors on the properties of powder masses and the main quality indicators of tablets with plant extracts and essential oil, the method of random balance was used. The obtained powder mixtures and tablets based on them were subjected to the determination of the following pharmaco-technological parameters: bulk density, tapped density, flowability, the angle of repose, the uniformity of weight, tablet hardness testing, the friability test, disintegration time, desirability function. The pharmaco-technological index of bulk density improves with an increase in the amount of Pregelatinized Starch, Mannitol 60, Emcompress, as well as a decrease in the amount of Neusilin UFL2 and Neusilin US2. Regarding the tapped density, Neusilin US2 significantly affects it, with the increase of which this indicator decreases. With the introduction of more Neusilin US2, Mannitol 60, Pregelatinized Starch, Ludipress, Emcompress and Magnesium Stearate, the value of the angle of repose is improved. The average mass has the greatest influence on fluidity, at its decrease this indicator improves. The same happens with the introduction of Neusilin UFL2, Neusilin US2, Pregelatinized Starch and Magnesium Stearate. The uniformity of weight of all series of tablets fluctuates within ± 5%, and friability to 1%, which meets the requirements of the State Pharmacopoeia of Ukraine. Also, despite the results obtained, all series of tablets were very strong, with the lowest tablet hardness testing – 159 N. The disintegration of the tablets varies within 6 minutes. After evaluating the results of the scattering diagrams of all pharmaco-technological parameters as well as the desirability function, Neusilin US2, МCC 102, Sodium croscarmellose, Mannitol 60 and Magnesium Stearate were selected for further research. The average weight of tablets should be increased to 0.55 g.


2021 ◽  
pp. 73-81
Author(s):  
Svitlana Chernetska ◽  
Natalia Beley ◽  
Mariana Demchuk

The aim. The aim of the research was to study the influence of excipients amount on the technological parameters of the compression mixture and tablets based on dry extract of Origanum vulgare L. herb using the method of random balance. Materials and methods. Objects of the study – Origanum vulgare L. herb dry extract, 8 excipients that have been studied at two quantitative levels. The tablets were prepared by direct compression method. The formulations were designed according to the method of random balance. The technological parameters of the compression mixture and tablets based on Origanum vulgare L. herb dry extract have been studied as a function of quantitative factors: silicon, magnesium carbonate basic, dioxide magnesium aluminometasilicate (Neusilin S1®), isomalt (GalenIQ™720), F-melt® Type C (co-spray dried excipients), sucralose, berry flavor and citric acid. Results and discussion. The increase in the amount of Neusilin S1®, GalenIQ™720 and F-melt®, and the decrease in the amount of magnesium carbonate basic and silicon dioxide improved the flowability expressed by the Hausner ratio. Results of bulk density and tapped density of the compression mixture depended on the quantities of GalenIQ™720 and F-melt®. All formulations of the prepared tablets had the rapid disintegration and ranging from 6 to 15 minutes. Resistance for crushing and friability tablets’ were improved with a decrease in the amount of silicon dioxide and increase in the amount of Neusilin S1®, F-melt® and sucralose. Higher resistance to moisture of tablets based on Origanum vulgare L. dry extract was obtained by using Neusilin S1®, F-melt® and sucralose on the upper levels. Conclusions. The tablets based on Origanum vulgare L. herb dry extract were successfully manufactured by direct compression method. The random balance method enabled us to identify the most significant quantitative factors to optimize their composition in the tablets based on the dry extract of Origanum vulgare L. herb.


2017 ◽  
Vol 9 (4) ◽  
pp. 92
Author(s):  
Hrishav Das Purkayastha ◽  
Bipul Nath

Objective: The aim of the present investigation was to design and evaluate orally disintegrating tablet (ODT) of Ibuprofen, a NSAID drug used for the treatment of arthritis with a view to improve its oral bioavailability. The focus of the current study was to develop ODT of Ibuprofen using super disintegrants for ease of administration and its physicochemical characterization.Methods: Tablets were made from blends by direct compression method. All the ingredients were passed through mesh no. 80. All the ingredients were co-ground in a pestle motor. The resulting blend was lubricated with magnesium stearate and compressed into tablets using the Cadmach single punch (round shaped, 8 mm thick) machine.Results: Physicals parameters of the prepared tablets like Hardness, Weight variation, Friability, thickness, drug content etc. found within the limits. The disintegration time of prepared ODTs was in the range of 45 to 55 seconds. In vitro dispersion time was found to be 22 to 52 seconds which may be attributed to faster uptake of water due to the porous structure formed by super disintegrants. Short disintegration and faster release of ibuprofen were observed with Cross carmellose sodium as compared to sodium starch glycollate.Conclusion: It is concluded that F3 offered the relatively rapid release of Ibuprofen when compared with other formulations. The increase in the concentrations of super disintegrants may lead to increase in the drug release. The formulation prepared with cross carmellose sodium was offered the relatively rapid release of Ibuprofen when compared with other concentrations of both the super disintegrant. 


Author(s):  
Krishna Mohan Chinnala ◽  
Sirish Vodithala

Objective: In the present study, efforts were taken to develop fast disintegrating tablets of Cinitapride hydrogen tartrate, is a gastro-prokinetic agent and antiulcer agent with an objective to achieve rapid disintegration, and further improving the bioavailability of the drug. Also, to resolve the swallowing problems (Dysphasia) in pediatric, geriatric patients by rapid disintegration in saliva and improve the patient compliance.Methods: Fast disintegrating tablets were prepared by direct compression method using superdisintegrants like crospovidone (CP), croscarmellose sodium (CCS), sodium starch glycolate (SSG) and combination of super-disintegrants in different concentrations. The prepared formulations were evaluated for the pre-compression parameters like bulk density, tapped density, Carr’s compressibility, Hausner’s ratio and angle of repose. The prepared batches of fast disintegrating tablets of Cinitapride hydrogen tartarate were evaluated for hardness, weight variation, thickness, friability, drug content, disintegration time, wetting time, water absorption ratio, and in vitro dissolution profile.Results: Bulk density and tapped density were found in the range of 0.412–0.432 g/cc and 0.507–0.528 g/cc respectively. In all formulations, tablet weight and thickness were within mean±9.5% and mean±5% respectively. Wetting time values lie between 19.76 to 39.53 sec. Water absorption ratio ranged from 57.30 to 78.82 %. The in vitro disintegration time for all the 12 formulations varied from 17.43 to 38.61 seconds. Formulation F8 which contained crosspovidone have recorded drug release 96.94±0.47% at the end of 30 min.Conclusion: The formulation containing crospovidone (F8) showed better performance in terms of disintegration time and drug release when compared to other formulations.


2015 ◽  
Vol 14 (1) ◽  
pp. 11-16
Author(s):  
T Mamatha ◽  
Md Zubair ◽  
N Sarah Nasreen ◽  
Md Ahmeduddin

The purpose of present research was to formulate and evaluate oro dispersible tablets (ODTs) of fosinopril sodium (FS). It has been developed at 20 mg dose and was prepared using different types of superdisintegrants such as (sodium starch glycolate, Ac-Di-Sol, crospovidone (CP), different types of subliming agents such as ammonium bicarbonate (AB) and camphor at different concentrations by direct compression method. The formulations were evaluated for uniformity of weight, content, hardness, friability, wetting time, in vitro dispersion time and dissolution rate. All formulations showed satisfactory mechanical strength, uniform weight, uniform drug content, and lesser wetting time and dispersion time. All the formulations showed more than 90% of drug release within 15 minutes. Among 10 formulations, formulation A5 (consisting of 2 % CP) and F4 (consisting of 15 % AB) were found to yield best results in terms of wetting time, in vitro dispersion time and dissolution rate.Dhaka Univ. J. Pharm. Sci. 14(1): 11-16, 2015 (June)


2020 ◽  
Vol 13 (4) ◽  
pp. 341-349
Author(s):  
B. M. Kadu ◽  
S. Bhasme ◽  
R. D. Bawankar ◽  
D. R. Mundhada

A. Rapimelt tablet of Lorazepam was prepared by direct compression method using Indion 414, Cross Carmellose Sodium and sodium starch glycolate as superdisintegrants with aim to get rapid onset of action, improve bioavailability and to give pleasant taste and better mouth feel. The tablets prepared were evaluated for various parameters like various density parameters, thickness, hardness, friability, disintegration time, wetting time and invitro dissolution time and were found to be within limits as per Indian Pharmacopoeia. FT-IR spectra of physical mixture of Lorazepam with Indion 414showedretention of basic peaks of Lorazepam. The developed formulation of Lorazepam batch F5 (10% Indion 414) showed good palatability and dispersed within 30 seconds as compared to Crosscarmellose Sodium batches F1-F3 and Sodium starch glycolate batches F6-F9.


2021 ◽  
Vol 9 (10) ◽  
pp. 1277-1286
Author(s):  
Sarvesh Patel ◽  
◽  
Jai Narayan Mishra ◽  
Dhaneswar Kumar Vishwakarma ◽  
◽  
...  

Finally in the project work Atenolol is an anti-hypertensive drug. It has been formulated into fast dissolving tablets by direct compression method by using the Excipients like lactose, sucrose magnesium stearate, sodium lauryl and sulphate and many type super disintegrates such as crosscarmellose and sodium starch glycolate and the prepared by the tablets were evaluated for the pre-compression parameter such as angle of repose, bulk density, tapped density, % index, Hausners ratio, partition coefficients, melting points, UV spectroscopy, % assay, TLC, loss on drying and post compression parameter such as thickness, hardness, friability, drugs contents, weight variation, water absorbance ratio, Invitro disintegrating time , Invitro dissolution studies. All the parameter shows good results. FDTs are prepared by direct compression method are results found to be that the among of nine formulation as the F9 to be best as its shows 87.10% (direct compression method) maximum drug release respectively. The stability testing of manufactured tablets have being at 400 c having 75% relativity humidity for 1month and found to be stable. Prepared fast dissolving tablets of Atenolol 10 mg was found to be under fasting federal condition.


Author(s):  
A. HARI OM PRAKASH RAO ◽  
R. SANTOSH KUMAR ◽  
SHAMBHAVI KANDUKURI ◽  
M. RAMYA

Objective: To synthesize, characterize and evaluate starch glycolate as a superdisintegrant in the formulation of Glipizide fast dissolving tablets by employing 23 factorial designs. Methods: Starch glycolate was prepared and its physical and micromeritic properties were performed to evaluate it. The fast dissolving tablet of Glipizide was prepared by employing starch crotonate as a superdisintegrant in different proportions in each case by direct compression method using 23 factorial design for the evaluation of tablet parameters like disintegration and dissolution efficiency in 5 min. Results: The starch glycolate prepared was found to be fine, free-flowing and amorphous. Starch glycolate exhibited good swelling in water with a swelling index (10%). The study of starch glycolate was shown by fourier transform infrared spectra (FTIR). The drug content (100±5%), hardness (3.5–4 kg/sq. cm), and friability (<0.15%) was been effective with regard to all the formulated fast dissolving tablets employing starch glycolate. The disintegration time of all the formulated tablets was found to be in the range of 13±0.015 to 180±0.014 sec. The optimized formulation F8 had the least disintegration time i.e., 13±0.015 sec. The wetting time of the tablets was found to be in the range of 8±0.015 to 95±0.013 sec. The In vitro wetting time was less (i.e., 8±0.015s) in optimized formulation F8. The water absorption ratio of the formulated tablets was found to be in the range of 75±0.012 to 150±0.014%. The percent drug dissolved in the optimized formulation F8 was found to be 99.95% in 5 min. Conclusion: Starch glycolate was an efficient superdisintegrant for fast-dissolving tablets. The disintegration and dissolution efficiency of the fast dissolving tablets of glipizide was good and depended on the concentration of superdisintegrant employed i.e., starch glycolate, sodium starch glycolate, crospovidone. The formulated fast dissolving tablets of glipizide exhibited good dissolution efficiency in 5 min which can be used for the fast therapeutic action of glipizide.


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).


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