Application of a Compaction Simulator to the Design of a High-Dose Tablet Formulation. Part I

1996 ◽  
Vol 22 (9-10) ◽  
pp. 967-975 ◽  
Author(s):  
Mandana Asgharnejad ◽  
David E. Storey
Keyword(s):  
Tablet Formulation ◽  
High Dose ◽  
Compaction Simulator ◽  
Dose Tablet

Stability Indicating HPTLC Method for Simultaneous Determination of Amlodipine Besylate and Lisinopril in Combined Dose Tablet Formulation

2021 ◽  
pp. 6250-6256
Author(s):  
Sagar B. Wankhede ◽  
Deepak S. Khobragade ◽  
Sukeshini B. Lote ◽  
S. Patil
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
Degradation Products ◽  
Cost Effective ◽  
Tablet Formulation ◽  
Simultaneous Estimation ◽  
Amlodipine Besylate ◽  
Stability Indicating ◽  
Limit Of Quantitation ◽  
Dose Tablet

A combined dose tablet formulation containing Amlodipine besylate and Lisinopril is used for the treatment of essential hypertension. The present study reports development and validation of stability indicating high performance thin layer chromatographic method for simultaneous estimation of these drugs in combined dose tablet formulation. The two drugs were satisfactorily resolved on aluminum plates precoated with silica gel 60F254 using n-butanol : methanol: ammonia (4:4:1 v/v/v) as mobile phase. The Rf value for lisinopril and amlodipine besylate were 0.27±0.02 and 0.62±0.02, respectively. Densitometric evaluation of the separated bands was performed at 215nm. The calibration curves for lisinopril and amlodipine besylate were found to be linear in the concentration range of 1000-6000ng/band. The method was validated as per ICH guidelines for accuracy, precision, robustness, specificity, limit of detection and limit of quantitation. Statistical analysis proves that the method is suitable for simultaneous analysis of Lisinopril and Amlodipine besylate in pharmaceutical formulation without any interference from the excipients/degradant. The developed method offers several advantages such as sensitive, rapid, cost effective and less time consuming as compared to the reported methods. As the method could effectively separate the drugs from its degradation products, it can be employed as a stability indicating method.

Application of Melt Granulation Technology Using Twin-screw Extruder in Development of High-dose Modified-Release Tablet Formulation

2011 ◽  
Vol 100 (5) ◽  
pp. 1923-1934 ◽  
Author(s):  
Madhav Vasanthavada ◽  
Yanfeng Wang ◽  
Thomas Haefele ◽  
Jay P. Lakshman ◽  
Manisha Mone ◽  
...  
Keyword(s):  
Tablet Formulation ◽  
High Dose ◽  
Twin Screw Extruder ◽  
Modified Release ◽  
Screw Extruder ◽  
Twin Screw ◽  
Granulation Technology ◽  
Melt Granulation ◽  
Release Tablet

Lopinavir/Ritonavir Pharmacokinetics in a Substitution of High-Dose Soft-Gelatin Capsule to Tablet Formulation

2009 ◽  
Vol 49 (2) ◽  
pp. 155-161 ◽  
Author(s):  
Mark W. Hull ◽  
Marianne Harris ◽  
Viviane Lima ◽  
Silvia Guillemi ◽  
P. Richard Harrigan ◽  
...  
Keyword(s):  
Tablet Formulation ◽  
High Dose ◽  
Gelatin Capsule ◽  
Soft Gelatin Capsule

scholarly journals Comparison of drug release and mechanical properties of tramadol-hydrochloride matrix tablets prepared with selected hydrophilic polymers

2015 ◽  
Vol 21 (3) ◽  
pp. 369-378
Author(s):  
Nenad Nikolic ◽  
Djordje Medarevic ◽  
Jelena Djuris ◽  
Dragana Vasiljevic
Keyword(s):  
Mechanical Properties ◽  
Drug Release ◽  
Large Scale ◽  
Mechanical Characteristics ◽  
Matrix Tablets ◽  
Hydrophilic Polymers ◽  
High Dose ◽  
Compression Pressure ◽  
Tramadol Hydrochloride ◽  
Compaction Simulator

This study investigates using of high molecular weight hydrophilic polymers, hypromellose and hydroxypropylcellulose, for the preparation of sustained release matrix tablets containing high dose, highly soluble drug, tramadol HCl. Proportion of polymer, type of insoluble filler, proportion of tramadol HCl, amount of drug in the tablet and compression pressure were recognized as critical formulation and process parameters and their influence on drug release and tablet mechanical properties was evaluated. Tensile strength was used as indicator of mechanical properties of the tablets. Experiments were performed with utilization of compaction simulator as a device which simulates compaction profiles of large scale rotary tablet presses. In formulations with both polymers proportion of tramadol HCl was the most critical formulation parameter wherein increasing of the tramadol HCl proportion increased its release rate in early stages of drug release. Regarding the tablet mechanical characteristics, the influence of the filler type has the most pronounced effect in formulations with both polymers. Higher tensile strengths were obtained with Avicel PH 102 as filler in formulations with both HPMC and HPC.

Sign in / Sign up

Export Citation Format

Share Document