DESIGN AND EVALUATION OF DOMPERIDONE FAST DISINTEGRATING TABLETS BY WET GRANULATION TECHNIQUES USING PLANTAGO OVATA MUCILAGE

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (06) ◽  
pp. 49-54
Author(s):  
S M Shahidulla ◽  
◽  
Mohib Khan ◽  
K N Jayaveera

In the present study, fast disintegrating tablets of domperidone were prepared to enhance patient compliance by wet granulation method. In the study, fast disintegrating tablets of the drug using, Plantago ovata mucilage and Crospovidone were used as superdisintegrants (2.5 to 10 % w/w) along with starch paste as a binder. The disintegrant was incorporated during the wet granulation process as an extra granular incorporation. The prepared tablets were evaluated for hardness, friability, drug content uniformity, wetting time, water absorption ratio and in vitro dispersion time. Based on in vitro dispersion time (approximately 12 s), the two formulations were tested for in vitro drug release, short term stability (at 40o /75 % RH for 3 months) and drug excipient interaction (IR spectroscopy). Among the two promising formulations, the formulations prepared by using 10% w/w of Plantago ovata mucilage and 32% w/w of starch paste emerged as the overall best formulation (t50 % 2.90 min) compared to conventional commercial tablets formulations (t50% 7.85 min). Short-term stability studies on the formulations indicated that there are no significant changes in drug content and in vitro dispersion time (p<0.05).

Author(s):  
SARIPILLI RAJESWARI ◽  
M. YERNI KUMARI

Objective: The main aim of the present research work was to formulate fast dissolving tablets of famotidine by direct compression method and to evaluate the effect of synthetic super disintegrating agent on drug release pattern. Methods: The fast dissolving tablets were prepared by using crospovidone, croscarmellose sodium, sodium starch glycolate as superdisintegrants (2, 4 and 6 %w/w), mannitol 20 % and microcrystalline cellulose (44, 46 and 48 % w/w) as a directly compressible vehicle. All the prepared tablets were evaluated for hardness, friability, drug content uniformity, weight variation, disintegrating time, wetting time and in vitro drug release studies. Results: All the prepared fast dissolving tablets formulations were within the Pharmacopoeial standards limits. Based on in vitro drug release studies (>90 % within 30 min), the optimised formulations were optimised tested for the short term stability (at 40 ˚C/75% RH for 3 mo) and drug excipient interaction (fourier transform infrared spectroscopy). Conclusion: Hence, formulation prepared with 6 % w/w of crosspovidine and 44 % w/w of microcrystalline cellulose as emerged as the overall best formulation (>90 % within 30 min) compared to marketed product (>70 % within 30 min). Short-term stability studies on the formulations indicated that there are no significant changes in drug content and in vitro drug release (p<0.05).


2015 ◽  
Vol 4 (8) ◽  
pp. 415-419
Author(s):  
S. M. Shahidulla ◽  
Mohib Khan ◽  
K. N. Jayaveera

The present work was carried out to study the disintegrant property of plantago ovata mucilage. The objective of the work was to formulate Fast disintegrating tablets of Domperidon with a view to enhance patient compliances and dissolution rate by direct compression method using 3² full factorial design. Plantago ovata mucilage (2-10% w/w) was used as natural superdisintegrant and microcrystalline cellulose (0-30% w/w) was used as diluent, along with directly compressible mannitol to enhance mouth feel. The tablets were evaluated for hardness, friability, thickness, drug content uniformity, in vitro dispersion time, wetting time and water absorption ratio. Based on in vitro dispersion time (approximately 10s); the formulation containing 10% w/w Plantago ovata mucilage and 30%w/w microcrystalline cellulose was found to be promising and tested for in vitro drug release pattern (in 0.1 N HCl), short-term stability (at 40º/75% RH for 3 month) and drug-excipient interaction. Surface response plots are presented to graphically represent the effect of independent variables (concentrations of Plantago ovata mucilage and microcrystalline cellulose) on the in vitro dispersion time. The validity of the generated mathematical model was tested by preparing two extra-design check point formulations. The optimized tablet formulation was compared with conventional commercial tablet formulation for drug release profiles. This formulation showed nearly four-fold faster drug release (t50% 2.85 min) compared to the conventional commercial tablet formulation (t50% 7.85 min). Short-term stability studies on the formulation indicated that there are no significant changes in drug content and in vitro dispersion time (p < 0.05).Shahidulla et al., International Current Pharmaceutical Journal, July 2015, 4(8): 415-419


1970 ◽  
Vol 7 (1) ◽  
pp. 7-10 ◽  
Author(s):  
MA Momoh ◽  
MU Adikwu ◽  
SO Eraga

Orodispersible tablets of carbamazepine were prepared with a view to enhance patient compliance by direct compression method using 3² full factorial design. Crospovidone (2-10% w/w) was used as superdisintegrant and microcrystallinecellulose (0-30% w/w) was used as diluent, along with directly compressible mannitol to enhance mouth feel. The tablets were evaluated for hardness, friability, thickness, drug content uniformity, in vitro dispersion time, wetting time and water absorption ratio. Based on in vitro dispersion time (approximately 10 s); the formulation containing 2% w/w crospovidone and 30%w/w microcrystallinecellulose was found to be promising and tested for in vitro drug release pattern (in pH 6.8 phosphate buffer), short-term stability (at 40º/75 % RH for 3 w) and drug-excipient interaction. This formulation showed four-fold faster drug release (t25%) compared to the conventional commercial tablet formulation. Short-term stability studies on the formulation indicated that there are no significant changes in drug content and in vitro dispersion time (p < 0.05).  Key words: mucin, Prosopis gum, cicatrin, healingDOI = 10.3329/dujps.v7i1.1200Dhaka Univ. J. Pharm. Sci. 7(1): 7-10, 2008 (June)


INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (01) ◽  
pp. 34-40
Author(s):  
V.L Narasaiah ◽  
◽  
Ch. Praneetha ◽  
P Mallika ◽  
K. Pullamma ◽  
...  

The aim of this project was to develop fast dissolving tablets (FDT) of aceclofenac by wet granulation using super disintegrating agents such as cross carmellose sodium (CCS), Crospovidone (CP) and sodium starch glycolate (SSG) were formulated and evaluated. The tablets evaluated for thickness, hardness, friability weight variation, drug content, water absorption ratio, wetting time, disintegration time and in vitro dissolution studies. The in vitro release studies were conducted in pH 7.4 phosphate buffer. Different release models like zero order, first order, Higuchi and Korsmeyer-Peppas were applied to in vitro drug release data in order to evaluate drug release mechanisms and kinetics. The formulation ‘F4’ showed satisfactory physico-chemical properties and drug content uniformity. The formulation ‘F4’ follows first order kinetics and the mechanism of drug release was governed by Higuchi. The ‘n’ value showed between <0.5, it was followed that Fickian transport. The FTIR studies were conducted and it shows that there is no interaction between drug and excipients.


1970 ◽  
Vol 7 (1) ◽  
pp. 1-5
Author(s):  
PV Swamy ◽  
SM Shahidulla ◽  
SB Shirsand ◽  
SN Hiremath ◽  
Md Younus Ali

Orodispersible tablets of carbamazepine were prepared with a view to enhance patient compliance by direct compression method using 3² full factorial design. Crospovidone (2-10% w/w) was used as superdisintegrant and microcrystallinecellulose (0-30% w/w) was used as diluent, along with directly compressible mannitol to enhance mouth feel. The tablets were evaluated for hardness, friability, thickness, drug content uniformity, in vitro dispersion time, wetting time and water absorption ratio. Based on in vitro dispersion time (approximately 10 s); the formulation containing 2% w/w crospovidone and 30%w/w microcrystallinecellulose was found to be promising and tested for in vitro drug release pattern (in pH 6.8 phosphate buffer), short-term stability (at 40º/75 % RH for 3 w) and drug-excipient interaction. This formulation showed four-fold faster drug release (t25%) compared to the conventional commercial tablet formulation. Short-term stability studies on the formulation indicated that there are no significant changes in drug content and in vitro dispersion time (p < 0.05).Key words: Orodispersible tablets, carbamazepine, crospovidone, micro crystallinecellulose, 3² full factorial designDOI = 10.3329/dujps.v7i1.1199Dhaka Univ. J. Pharm. Sci. 7(1): 1-5, 2008 (June)


Author(s):  
Suresh Kulkarni ◽  
Ranjit P. ◽  
Nikunj Patel ◽  
Someshwara B. ◽  
Ramesh B. ◽  
...  

The present investigation deals with the formulation of fast disintegrating tablets of Meloxicam that disintegrate in the oral cavity upon contact with saliva and there by improve therapeutic efficacy. Meloxicam is a newer selective COX-1 inhibitor. The tablets were prepared by wet granulation procedure. The influence of superdisintegrants, crosspovidone, croscaremellose sodium on disintegration time, wetting time and water absorption ratio were studied. Tablets were evaluated for weight and thickness variation, disintegration time, drug content, in vitro dissolution, wetting time and water absorption ratio. The in vitro disintegration time of the best fast disintegrating tablets was found to be 18 sec. Tablets containing crospovidone exhibit quick disintegration time than tablets containing croscaremellose sodium. The fast disintegrating tablets of Meloxicam with shorter disintegration time, acceptable taste and sufficient hardness could be prepared using crospovidone and other excipients at optimum concentration.


2010 ◽  
Vol 103 (02) ◽  
pp. 461-465 ◽  
Author(s):  
Martina Böhm-Weigert ◽  
Thomas Wissel ◽  
Heidrun Muth ◽  
Bettina Kemkes-Matthes ◽  
Dirk Peetz

Summary In vitro D-dimer stability in plasma is widely assumed, but has not yet been documented by systematic studies using samples covering a wide range of D-dimer. We investigated the short- and long-term stability of D-dimer in clinical citrated plasma samples with normal and pathological levels. The short-term stability was analysed by measuring D-dimer fresh, after storage of plasma for 4 hours at room temperature (RT) and after an additional 24 h storage at +2 to +8°C (n=40). Long-term stability samples (n=40) were measured fresh and after storage for 19, 25 and 36 months at ≤-60°C. The effect of repeated freezing was analysed by measuring samples (n=50) fresh and after four consecutive freeze-thaw cycles. D-dimer was measured on the BCS System using the INNOVANCE D-Dimer assay (Siemens Healthcare Diagnostics Products GmbH, Marburg, Germany). D-dimer values at baseline ranged from 0.23–22.2 mg/l FEU. The mean percentage change after storage for 4 hours at RT and additional 24 hours at +2 to +8°C was +3.8% and +2.7%, respectively. The mean percentage change after frozen storage for 19, 25 and 36 months at ≤-60°C was –11.7%, –4.8% and –9.3%, respectively. The small decrease of D-dimer values after frozen storage was not time-dependent. Repeated freezing did not significantly alter D-dimer values (mean change ≤5%). The data demonstrate stability of D-dimer in plasma prior to freezing for up to 4 hours at RT and for up to 24 hours at +2 to +8°C as well as in plasma stored for up to three years at ≤-60°C.


2019 ◽  
Vol 9 (6) ◽  
pp. 90-94
Author(s):  
Ashish Gupta ◽  
Juhi Bhadoria ◽  
G.N. Darwhekar

Orodispersible tablets (ODTs), also known as fast melt, quick melts, fast disintegrating have the unique property of disintegrating in the mouth in seconds without chewing and the need of water. Oral bioavailability of Atorvastatin Calcium is low (14%) and shows extensive intestinal clearance and first-pass metabolism, which is the main cause for the low systemic availability. In the present work, orodispersible tablets of Atorvastatin calcium were prepared by direct compression method using Hibiscus rosa sinesis mucilage as natural superdisintegrant with a view to enhance patient compliance and to avoid hepatic first pass metabolism and to improve its bioavailability. The prepared batches of tablets were evaluated for hardness, friability, drug content uniformity, wetting time, water-absorption ratio and in-vitro dispersion time. Short-term stability studies on the promising formulation indicated that there are no significant changes in drug content and in vitro dispersion time. Keywords: Orodispersible tablet, Atorvastatin Calcium, lipid-lowering agent, Superdisintegrant, Hibiscus Rosa Sinensis, Bioavailability, solubility. 


2020 ◽  
Vol 64 (4) ◽  
pp. 391-400 ◽  
Author(s):  
Balázs Démuth ◽  
Gergő Fülöp ◽  
Márk Kovács ◽  
Lajos Madarász ◽  
Máté Ficzere ◽  
...  

Homogeneous ultralow-dose (30 mg) tablets were prepared from perfectly free-flowing granules manufactured by continuous Twin-Screw Wet Granulation. The gravimetrically fed mixture of lactose and potato starch of low particle size was successfully agglomerated and the size enlargement technology proved to be very robust. Since the incorporated drug was dissolved in ethanol-based granulation liquid, the resulting homogeneity largely depended on the dosing of the applied liquid administering units.A peristaltic pump generated higher deviation of the drug content in tablets (Relative Standard Deviation (RSD): 7.7 %) compared to a syringe pump (RSD: 2.3 %) or a piston pump (RSD: 4.6 %). This is due to the pulsation of the liquid flow generated by the peristaltic pump according to the real-time measured mass of the fed liquid. A good correlation was found between the RSD of the liquid mass flow (calculated from the recorded masses) and the RSD of the drug content. Based on the results, the goodness of Content Uniformity, as the most relevant critical quality attribute of low-dose products, was determined by the characteristics of the applied dosing units. The feeding characteristic of the different pumps could be easily measured by the introduced balance-based method and therefore, the applicability of the pumps could be evaluated.


Author(s):  
P. V. Swamy ◽  
Laeeq Farhana ◽  
S. B. Shirsand ◽  
Md.Younus Ali ◽  
Ashokgoud Patil

Carvedilol (non-cardio selective b-blocker) is an antihypertensive used in management of hypertension, angina pectoris and heart failure.  But its oral bioavailability is about 25-35% only due to significant degree of first pass metabolism.  It has gastrointestinal side effects such as diarrhea, gastric pain and irritation.  Hence, rectal suppositories of carvedilol were developed by using different water-soluble polymeric bases like gelatin and agar-agar using propylene glycol as plasticizer. The gelatin suppositories were disintegrating/dissolving type while gelatin–agar based suppositories were non-disintegrating/non-melting. All the formulations were evaluated for various physical parameters like weight variation,  drug content uniformity, liquefaction time, micro-melting range, in vitro dissolution, short-term stability and drug-excipient interaction (FTIR).  The mechanism of drug release was diffusion controlled and follows first order kinetics in majority of cases. The results suggested that when gelatin is replaced up to 25% w/w with agar, liquefaction time and drug release were not appreciably affected; higher proportions of agar exhibited incomplete and slow release.  Stability studies conducted at 25±3º C and 60±5% relative humidity for three months indicated that the formulations were stable in the drug-content and in vitro drug release rate (p<0.05).


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