scholarly journals Development and biopharmaceutical evaluation of extended release formulation of tramadol hydrochloride based on osmotic technology

2009 ◽  
Vol 59 (1) ◽  
pp. 15-30 ◽  
Author(s):  
Pramod Kumar ◽  
Sanjay Singh ◽  
Brahmeshwar Mishra
Keyword(s):  
Drug Release ◽  
Extended Release ◽  
Relative Bioavailability ◽  
Pharmacokinetic Parameters ◽  
Healthy Human ◽  
Tramadol Hydrochloride ◽  
Release Formulation ◽  
Extended Release Formulation

Development and biopharmaceutical evaluation of extended release formulation of tramadol hydrochloride based on osmotic technologyExtended release formulation of tramadol hydrochloride (TRH) based on osmotic technology was developed and evaluated. Target release profile was selected and different variables were optimized to achieve it. Formulation variables such as the level of swellable polymer, plasticizer and the coat thickness of semipermeable membrane (SPM) were found to markedly affect drug release. TRH release was directly proportional to the levels of plasticizer but inversely proportional to the levels of swellable polymer and coat thickness of SPM. Drug release from developed formulations was independent of pH and agitation intensity but dependent on osmotic pressure of the release media.In vivostudy was also performed on six healthy human volunteers and various pharmacokinetic parameters (cmax,tmax,AUC0-24,MRT) and relative bioavailability were calculated. Thein vitroandin vivoresults were compared with the performance of two commercial TRH tablets. The developed formulation provided more prolonged and controlled TRH release compared to the marketed formulation.In vitro-in vivocorrelation (IVIVC) was analyzed according to the Wagner-Nelson method. The optimized formulation (batch IVB) exhibited good IVIV correlation (R= 0.9750). The manufacturing procedure was found to be reproducible and formulations were stable over 6 months of accelerated stability testing.

In vitro and in vivo release of dinalbuphine sebacate extended release formulation: Effect of the oil ratio on drug release

2017 ◽  
Vol 531 (1) ◽  
pp. 306-312 ◽  
Author(s):  
Chan-Jung Li ◽  
Mei-Yun Ku ◽  
Chia-Yin Lu ◽  
Yu-En Tien ◽  
Wendy H. Chern ◽  
...  
Keyword(s):  
Drug Release ◽  
Extended Release ◽  
Release Formulation ◽  
Extended Release Formulation ◽  
In Vivo Release

scholarly journals In Vitro and In Vivo Evaluation of pH-Sensitive Hydrogels of Carboxymethyl Chitosan for Intestinal Delivery of Theophylline

2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Hemant Kumar Singh Yadav ◽  
H. G. Shivakumar
Keyword(s):  
Drug Release ◽  
Sustained Release ◽  
Extended Release ◽  
Carboxymethyl Chitosan ◽  
Ph Sensitive ◽  
Acidic Ph ◽  
Release Formulation ◽  
Nocturnal Asthma

Chitosan is a natural polymer which has limited solubility. Chitosan gets solubilized at acidic pH but is insoluble at basic pH. In the present study, carboxymethyl chitosan (CMC) was prepared which shows high swelling in basic pH and thus can delay the drug release and can act as matrix for extended release formulation. CMC was characterized by FTIR and NMR. pH-sensitive hydrogels of theophylline were formulated using CMC and carbopol 934. Hydrogels were evaluated for swelling, drug content in vitro drug release studies, and in vivo studies on rabbit. The swelling studies have shown little swelling in acidic pH 432% at the end of two hours and 1631% in basic pH at the end of 12 hours. The release profile of the formulation I containing CMC and carbopol in 1 : 1 ratio showed sustained release. In vivo studies showed that the release of theophylline from the prepared hydrogel formulation (Test) exhibit better prolonged action when compared to (standard) marketed sustained release formulation. The studies showed that the pH-sensitive hydrogel of CMC can be used for extended release of theophylline in intestine and can be highly useful in treating symptoms of nocturnal asthma.

Development of an Extended-Release Formulation of Capecitabine Making Use of In Vitro–In Vivo Correlation Modelling

2014 ◽  
Vol 103 (2) ◽  
pp. 478-484 ◽  
Author(s):  
Jelte Meulenaar ◽  
Ron J. Keizer ◽  
Jos H. Beijnen ◽  
Jan H.M. Schellens ◽  
Alwin D.R. Huitema ◽  
...  
Keyword(s):  
Extended Release ◽  
Release Formulation ◽  
Extended Release Formulation ◽  
Correlation Modelling

scholarly journals Vomiting is a Potential Adverse Drug Reaction for Levomilnacipran

2017 ◽  
Vol 9 (05) ◽  
Author(s):  
Atreyee Sarkar ◽  
Shivanand Dhanure
Keyword(s):  
Adverse Drug Reaction ◽  
Adverse Reaction ◽  
Extended Release ◽  
Pharmacokinetic Parameters ◽  
Regulatory Requirements ◽  
Healthy Human ◽  
Release Formulation ◽  
Extended Release Formulation ◽  
Human Volunteers ◽  
The Us

Levomilnacipran is a drug used to treat depression. Micro Labs is a generic drug company which had developed an extended release formulation of Levomilnacipran 120 mg capsule. Two studies were conducted to assess the safety, tolerability and bioequivalence of the extended release formulation of 120 mg Levomilnacipran capsules. A total of 42 subjects had been included for each of the fasting and fed studies. Out of them, 30 subjects completed the fasting study and 28 subjects completed the fed study. Pharmacokinetic parameters like Cmax, AUC0-t, AUC0-inf, Tmax, Kel, t1/2 and %AUCextra were calculated for Levomilnacipran in order to compare the bioavailability of the test and reference formulations. The studies were conducted in healthy human volunteers in both fasting and fed conditions as per the US regulatory requirements for conduct of bioequivalence studies. The formulations were found to be bioequivalent to each other. Vomiting was observed as a major adverse reaction.

scholarly journals Development of an Extended-Release Formulation for Apremilast and a Level A in Vitro–in Vivo Correlation Study in Beagle Dogs

2016 ◽  
Vol 64 (11) ◽  
pp. 1607-1615 ◽  
Author(s):  
Meiqiong Tang ◽  
Ping Hu ◽  
Shigui Huang ◽  
Qiang Zheng ◽  
Hao Yu ◽  
...  
Keyword(s):  
Extended Release ◽  
Correlation Study ◽  
Beagle Dogs ◽  
Release Formulation ◽  
Extended Release Formulation
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