scholarly journals The Challenges of Producing Bilayer Tablet: A Review

2021 ◽  
Vol 11 (4-S) ◽  
pp. 171-175
Author(s):  
Abhay Singh ◽  
Sudip Das ◽  
Sabnam Gupta ◽  
Suman Ghosh
Keyword(s):  
Single Dose ◽  
Effective Treatment ◽  
Patient Compliance ◽  
Immediate Release ◽  
Bilayer Tablet ◽  
Advanced Form ◽  
Technological Stage ◽  
Tablet Manufacturing ◽  
State Of Art ◽  
Selection Of

Bilayer tablets are the advanced form of conventional immediate release tablet system, which consist of either two similar or different drugs combined in a single dose for effective treatment of the disease improving patient compliance. However, the multilayer tablet technology is demanding It also necessitates meticulous selection of excipients and manufacturing conditions for each technological stage. The aim of this review is to provide an outline of state of art of bilayer tablet technology and emphasise the difficulties experienced during Bilayer tablet manufacturing along with its  intend solutions for these challenges. Keyword: Bilayer tablet, Conventional release, Challenges encountered, Compliance.

Technologies in Bilayer Tablet Manufacturing: A Review

2021 ◽  
pp. 253-258
Author(s):  
Mayuri B. Patil ◽  
Priyanka M. Salve ◽  
Shital V. Sonawane ◽  
Avish D. Maru ◽  
Jayshree S. Bhadane ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Controlled Release ◽  
Immediate Release ◽  
Successful Development ◽  
Release Formulation ◽  
The Past ◽  
Bilayer Tablet ◽  
Release Drug ◽  
Tablet Manufacturing ◽  
The Cost

Bilayer tablet is a recent time for the successful development of controlled release formulation along with various quality to provide a way of the successful drug delivery system. Over the past 30 years stated that the cost and complications involved in marketing new drug entities have increased, with consequent recognition of therapeutic advantages of controlled drug delivery, greater attention has been concentration on development of sustained or controlled release drug delivery systems. Bilayer tablet it is used in the different aspect for anti-inflammatory and analgesic. Bilayer tablet incidental release of two drugs in combination, separate two incompatible substance and also for sustained release tablet in which one layer is immediate release as initial dose and second layer is maintenance dose. Bilayer tablet is enhancing beneficial technology to control the shortcoming of the single layered tablet. There is various application used in the bilayer tablets.

scholarly journals DEVELOPMENT OF BILAYER TABLETS FOR IMMEDIATE AND CONTROLLED RELEASE OF ALLICIN

2017 ◽  
Vol 9 (4) ◽  
pp. 153
Author(s):  
Manoj Kr. Das ◽  
Bhanu P. Sahu ◽  
Jahan Nur Rahman Hazarika
Keyword(s):  
Controlled Release ◽  
Sustained Release ◽  
Effective Treatment ◽  
In Vitro Release ◽  
Immediate Release ◽  
Optimum Result ◽  
Bilayer Tablet ◽  
Weight Variation ◽  
Formulation Parameters

Objective: The purpose of this study was to develop and evaluate bilayer tablet for the immediate and controlled release of Allicin (Garlic Extract) for effective treatment of Hypertension.Methods: The immediate release layer was prepared by using super disintegrants-sodium starch glycolate and binder used xantham gum and the sustained release layer was prepared by using hydrophilic polymer like HPMC K 100 and PVP. Before preparation of the tablets, all the pre-formulation parameters were checked and the tablet of Allicin were prepared by direct compression method and was evaluated for physical characteristics like hardness, weight variation, drug content and friability. In vitro release of drug was performed USP type II dissolution test apparatus using phosphate buffer (pH 7.4) as dissolution media and dissolution was continued for 8 hrs for the sustained release layer.Results: It was found that all the formulations were within the limit of the standard. The drug release of the tablet was in the range of 66%-83% in 8 h.Conclusion: It was concluded that the F4 formulation showed the optimum result as a bilayer tablet for the effective treatment of hypertension. 

Development of Bilayer Tablet Containing Saxagliptin Immediate Release and Metformin Sustained Release using Quality by Design Approach

2021 ◽  
Vol 16 ◽  
Author(s):  
Amit Kaushal ◽  
Sandeep Arora ◽  
Neelam Sharma ◽  
Sukhbir Singh
Keyword(s):  
Drug Release ◽  
Sustained Release ◽  
Patient Compliance ◽  
Numerical Optimization ◽  
Quality By Design ◽  
Immediate Release ◽  
Magnesium Stearate ◽  
Fixed Dose ◽  
Bilayer Tablet ◽  
Independent Parameters

Objective: Adequate glycemic control in diabetes patients requires oral combination therapy. Saxagliptin is a dipeptidyl peptidase-4 inhibitor having less adverse effects and metformin is a first line medicine for diabetes treatment. The aim of this research work is to develop a bilayer tablet of saxagliptin and metformin in fixed dose combination (FDC) using quality by design (QbD) to acquire immediate release of saxagliptin and sustained release of metformin from bilayer tablet to ultimately achieve superior patient compliance. Methods: The development of the bilayer tablet was done in four stages using QbD. In first step, quality target product profile (QTPP) of bilayer tablet was defined and critical quality attributes (CQAs) were identified by risk estimation matrix and taguchi design, an immediate release saxagliptin layer was optimized in second step, optimization of sustained release metformin layer was carried out in third step and in final step bilayer tablet was prepared and characterized. The effect of independent parameters i.e. magnesium stearate level (X1), kneading time (X2) and lubrication time (X3) on Carr’s Index (Y1), percentage relative standard deviation of content uniformity (Y2) and drug release at 30 minute (Y3) were estimated for optimization of immediate release saxagliptin layer using Box-Behnken design (BBD). The effect of independent parameters i.e. hydroxypropyl methyl cellulose level (X4), compritol level (X5) and magnesium stearate level (X6) on Carr’s Index (Y4), drug release at 2 h (Y5), drug release at 5 h (Y6) and drug release at 10 h (Y7) were estimated for optimization of sustained release metformin layer using BBD. Results: The optimized composition of immediate release saxagliptin layer estimated using numerical optimization by Design expert was 0.88% (X1), 15 minutes (X2) and 3.85 minutes (X3) with predicted variables i.e. 10.59% (Y1), 3.16% (Y2) and 85% (Y3). The optimized composition of sustained release saxagliptin layer predicted through numerical optimization was 30% (X4), 3.36% (X5) and 0.9% (X6) having 10.89 % (Y4), 43.44 % (Y5), 60% (Y6) and 85.14% (Y7). In-vitro dissolution study of bilayer tablet showed immediate release of Saxagliptin (approximately 85% in 30 minute) and sustained release of metformin illustrating 43.21±1.21, 60.86±2.96 and 86.26±1.38% drug release at 2, 5 and 10 h, respectively. The release exponent for Korsmeyer-Peppas model for Saxagliptin and metformin was 0.237 (<0.45) and 1.536 (n>0.85) indicating Fickian and super case II transport drug release behavior, respectively. Conclusion: By QbD approach, bilayer tablet containing saxagliptin and metformin was successfully developed and influence of various formulation parameters on CQAs of drug products was understood with fewer experiments. This leads to conclusion that cost can be reduced using QbD in development of FDC for improving patient compliance.

Update on the Treatment of Bacterial Urinary Tract Infections

1981 ◽  
Vol 15 (10) ◽  
pp. 738-750 ◽  
Author(s):  
Neil Massoud
Keyword(s):  
Biological Activity ◽  
Single Dose ◽  
Urinary Tract ◽  
Patient Compliance ◽  
Urinary Tract Infections ◽  
Antimicrobial Agents ◽  
Complex Problem ◽  
Tract Infections

The treatment of urinary tract infections (UTIs) has become a complex problem for the clinical practitioner. An understanding of the pharmacology, pharmacokinetics, and in vivo biological activity of antimicrobial agents is needed, as is an understanding of the variables that may influence patient compliance with medication regimens. Although UTIs are usually treated for 10 to 14 days, shorter treatment schedules of seven to ten days or even single-dose regimens are possible. Guidelines for the treatment of UTIs are presented along with suggestions for increased patient compliance.

scholarly journals 81 Bioequivalence of a Manipulation-Resistant Immediate-Release Amphetamine Sulfate Formulation Compared with Reference Standard

CNS Spectrums ◽  
2019 ◽  
Vol 24 (1) ◽  
pp. 216-216
Author(s):  
Steve Caras ◽  
Terrilyn Sharpe
Keyword(s):  
Single Dose ◽  
Healthy Volunteers ◽  
Peak Concentration ◽  
Immediate Release ◽  
Open Label ◽  
Time Curve ◽  
Time To Peak ◽  
Amphetamine Sulfate ◽  
Quantifiable Concentration ◽  
Funding Acknowledgements

AbstractStudy ObjectivesWe compared the bioavailability of racemic amphetamine (d-amphetamine and l-amphetamine) from a manipulation-resistant immediate-release (IR) amphetamine sulfate capsule (AR19) versus amphetamine sulfate IR tablets (reference).MethodIn this open-label, randomized, two-period, two-treatment, two-sequence, crossover study, 36 healthy volunteers aged 18–45 received a single dose (20-mg capsule) of AR19 in one period and a single dose (2 x 10-mg tablets) of reference in another period, after a 10-hour overnight fast. Each drug administration was separated by a washout period of at least 6days. Bioequivalence for d- and l-amphetamine was assessed using time to peak concentration (Tmax), peak concentration in plasma (Cmax), and area under the plasma concentration–time curve from time-zero to the time of the last quantifiable concentration (AUClast) and extrapolated to infinity (AUCinf).ResultsAll 36 volunteers completed both treatment sequences. Mean (standard deviation; SD) Tmax for d- and l-amphetamine was similar for AR19 (2.84[1.05]; 3.05[1.22], respectively) and reference (2.52[0.75]; 2.75[1.00], respectively). The geometric least-squares mean ratios and 90% confidence intervals were within the boundary of 80%–125% for bioequivalence for Cmax (d-amphetamine, 98.35% [96.12–100.64]; l-amphetamine, 98.82% [96.42–101.28]), AUClast (d-amphetamine, 99.45% [96.92–102.05]; l-amphetamine, 99.29% [96.55–102.10]), and AUCinf (d-amphetamine, 99.50%[96.77–102.30]; l-amphetamine, 99.23% [96.06–102.50]). A total of 13 mild adverse events were reported by 7 volunteers (AEs; AR19, n=5; reference, n=8). No serious AEs were reported.ConclusionAR19 was well tolerated and was bioequivalent to reference when administered as a 20-mg dose in healthy volunteers.Funding Acknowledgements: This study was funded by Arbor Pharmaceuticals, LLC.

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