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Takao Saruta - One of the best experts on this subject based on the ideXlab platform.
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comparison of efficacy and safety between Bisoprolol transdermal patch ty 0201 and Bisoprolol Fumarate oral formulation in japanese patients with grade i or ii essential hypertension randomized double blind placebo controlled study
Journal of Clinical Hypertension, 2013Co-Authors: Hiroaki Matsuoka, Iwao Kuwajima, Kazuyuki Shimada, Hideo Mitamura, Takao SarutaAbstract:TY-0201 (TY) is a new drug absorbed by the transdermal delivery system developed for the treatment of hypertension, which contains the free base of Bisoprolol Fumarate that is widely used. An 8-week randomized, double-blind, placebo-controlled study was conducted in hypertensive patients to evaluate the superiority of TY 8 mg to placebo and the noninferiority of TY 8 mg to Bisoprolol Fumarate oral formulation (BO) 5 mg. Changes in diastolic blood pressure (BP) (primary endpoint) from baseline in the TY 8 mg group, the BO 5 mg group, and the placebo group were −12.2 mm Hg, −11.8 mm Hg, and −3.7 mm Hg, respectively, with TY 8 mg demonstrating superiority to placebo and noninferiority to BO 5 mg. Changes from baseline for systolic BP and pulse rate produced significant reductions compared with placebo. TY is expected to serve as a new treatment approach for hypertensive patients.
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Comparison of Efficacy and Safety Between Bisoprolol Transdermal Patch (TY‐0201) and Bisoprolol Fumarate Oral Formulation in Japanese Patients With Grade I or II Essential Hypertension: Randomized, Double‐Blind, Placebo‐Controlled Study
Journal of clinical hypertension (Greenwich Conn.), 2013Co-Authors: Hiroaki Matsuoka, Iwao Kuwajima, Kazuyuki Shimada, Hideo Mitamura, Takao SarutaAbstract:TY-0201 (TY) is a new drug absorbed by the transdermal delivery system developed for the treatment of hypertension, which contains the free base of Bisoprolol Fumarate that is widely used. An 8-week randomized, double-blind, placebo-controlled study was conducted in hypertensive patients to evaluate the superiority of TY 8 mg to placebo and the noninferiority of TY 8 mg to Bisoprolol Fumarate oral formulation (BO) 5 mg. Changes in diastolic blood pressure (BP) (primary endpoint) from baseline in the TY 8 mg group, the BO 5 mg group, and the placebo group were −12.2 mm Hg, −11.8 mm Hg, and −3.7 mm Hg, respectively, with TY 8 mg demonstrating superiority to placebo and noninferiority to BO 5 mg. Changes from baseline for systolic BP and pulse rate produced significant reductions compared with placebo. TY is expected to serve as a new treatment approach for hypertensive patients.
Hiroaki Matsuoka - One of the best experts on this subject based on the ideXlab platform.
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comparison of efficacy and safety between Bisoprolol transdermal patch ty 0201 and Bisoprolol Fumarate oral formulation in japanese patients with grade i or ii essential hypertension randomized double blind placebo controlled study
Journal of Clinical Hypertension, 2013Co-Authors: Hiroaki Matsuoka, Iwao Kuwajima, Kazuyuki Shimada, Hideo Mitamura, Takao SarutaAbstract:TY-0201 (TY) is a new drug absorbed by the transdermal delivery system developed for the treatment of hypertension, which contains the free base of Bisoprolol Fumarate that is widely used. An 8-week randomized, double-blind, placebo-controlled study was conducted in hypertensive patients to evaluate the superiority of TY 8 mg to placebo and the noninferiority of TY 8 mg to Bisoprolol Fumarate oral formulation (BO) 5 mg. Changes in diastolic blood pressure (BP) (primary endpoint) from baseline in the TY 8 mg group, the BO 5 mg group, and the placebo group were −12.2 mm Hg, −11.8 mm Hg, and −3.7 mm Hg, respectively, with TY 8 mg demonstrating superiority to placebo and noninferiority to BO 5 mg. Changes from baseline for systolic BP and pulse rate produced significant reductions compared with placebo. TY is expected to serve as a new treatment approach for hypertensive patients.
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Comparison of Efficacy and Safety Between Bisoprolol Transdermal Patch (TY‐0201) and Bisoprolol Fumarate Oral Formulation in Japanese Patients With Grade I or II Essential Hypertension: Randomized, Double‐Blind, Placebo‐Controlled Study
Journal of clinical hypertension (Greenwich Conn.), 2013Co-Authors: Hiroaki Matsuoka, Iwao Kuwajima, Kazuyuki Shimada, Hideo Mitamura, Takao SarutaAbstract:TY-0201 (TY) is a new drug absorbed by the transdermal delivery system developed for the treatment of hypertension, which contains the free base of Bisoprolol Fumarate that is widely used. An 8-week randomized, double-blind, placebo-controlled study was conducted in hypertensive patients to evaluate the superiority of TY 8 mg to placebo and the noninferiority of TY 8 mg to Bisoprolol Fumarate oral formulation (BO) 5 mg. Changes in diastolic blood pressure (BP) (primary endpoint) from baseline in the TY 8 mg group, the BO 5 mg group, and the placebo group were −12.2 mm Hg, −11.8 mm Hg, and −3.7 mm Hg, respectively, with TY 8 mg demonstrating superiority to placebo and noninferiority to BO 5 mg. Changes from baseline for systolic BP and pulse rate produced significant reductions compared with placebo. TY is expected to serve as a new treatment approach for hypertensive patients.
Chhanda Das - One of the best experts on this subject based on the ideXlab platform.
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rp hplc method for simultaneous estimation of Bisoprolol Fumarate and hydrochlorothiazide in tablet formulation
Journal of Pharmaceutical and Biomedical Analysis, 2010Co-Authors: Sneha J Joshi, Pradnya A Karbhari, Suvarna I Bhoir, K S Bindu, Chhanda DasAbstract:Abstract A simple, precise and stability-indicating HPLC method was developed and validated for the simultaneous determination of Bisoprolol Fumarate and hydrochlorothiazide in pharmaceutical dosage form. The method involves the use of easily available inexpensive laboratory reagents. The separation was achieved on an Inertsil ODS 3V (25 cm × 4.6 mm) 5 μm column with isocratic flow. The mobile phase at a flow rate of 1.0 mL min −1 , consisted of 0.1 M potassium dihydrogen phosphate buffer and acetonitrile (70:30, v/v). The UV detection was carried out at 228 nm. A linear response was observed over the concentration range 2.5–50 μg mL −1 of Bisoprolol Fumarate and the concentration range 6.25–125 μg mL −1 of hydrochlorothiazide. Limit of detection and limit of quantitation for Bisoprolol Fumarate were 0.01 and 0.03 μg mL −1 , respectively and for hydrochlorothiazide were 0.01 and 0.05 μg mL −1 , respectively. The method was successfully validated in accordance to ICH guidelines acceptance criteria for specificity, linearity, accuracy, precision, robustness, ruggedness and system suitability. Individual drugs (Bisoprolol Fumarate and hydrochlorothiazide), their combinations and the tablets were exposed to thermal, photolytic, hydrolytic and oxidative stress conditions. The resultant stressed samples were analyzed by the proposed method. The method gave high resolution among the degradation products and the analytes. The peak purity of analyte peaks in the stressed samples was confirmed by photodiode array detector. The method was used for accelerated stability study on marketed and in-house formulations. The analysis concluded that the method was selective for simultaneous estimation of Bisoprolol Fumarate and hydrochlorothiazide and was stability-indicating.
Alina Diana Panainte - One of the best experts on this subject based on the ideXlab platform.
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New modified release tablets of Bisoprolol Fumarate for the treatment of hypertension: characterization and in vitro evaluation
Journal of Drug Delivery Science and Technology, 2019Co-Authors: Alina Diana Panainte, Carmen Gafitanu, Iulian Stoleriu, Liliana Mititelu Tarțău, Maria-cristina Popescu, Gabriela Lisa, E.g. PopaAbstract:Abstract Objectives The purpose of the study was to develop sustained release tablets containing Bisoprolol Fumarate and an innovative combination of Precirol ATO5 and hydroxypropyl methylcellulose, in order to conclude upon: properties of pharmaceutical tablet formulations, drug-excipients interactions, evaluate their in vitro release behavior. Methods The tablet formulations with rate controlling polymers were prepared by melt granulation technique. The physico-chemical characterization of new tablet formulation was performed by FT-IR spectroscopy, differential scanning calorimetry, thermogravimetric analysis and X-ray diffraction. The formulations were also evaluated for in vitro dissolution test to select the optimized formulation. Results Structural evaluation indicated the presence of interactions between tablet components which did not affect drug release. The tablets displayed good mechanical properties, with friability values close to zero and drug content was found to be uniform in all formulas. Release profile showed a tendency to follow Korsmeyer-Peppas and Higuchi kinetics. Conclusions In the present study we investigated the effect of concentration of matrix former compounds (hydroxypropyl methylcellulose and glyceril palmitostearate) on the release rate of Bisoprolol Fumarate. The study evidenced the assembling through physical bonds between the excipients and the drug, which do not affect the release of the bioactive compound.
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RP-HPLC ANALYSIS METHOD OF Bisoprolol Fumarate IN A NEW TABLET FORMULATION
2018Co-Authors: Alina Diana Panainte, Madalina Vieriu, Gladiola Tantaru, Mihai Apostu, Nela Bibire, Liliana Avasilcai, Ionela Daniela MorariuAbstract:RP-HPLC ANALYSIS METHOD OF Bisoprolol Fumarate IN A NEW TABLET FORMULATION (Abstract): Aim: Development of a new HPLC method for the quantitative determination of Bisoprolol Fumarate in a novel sustained release tablet formulation. Material and methods: The sustained release matrix tablets with Bisoprolol Fumarate were formulated using an innovative combination of hydroxypropyl methylcellulose and Precirol ATO5 as excipients. The HPLC separation was done using an Agilent Eclipse XDB-C18 column (150 mm ´ 4.6 mm, 5 µm) and a mobile phase consisting of acetonitrile 10 mM and pH 4.5 phosphate buffer solution (10:90, v/v) at a flow rate of 1.0 mL/min. The method was validated according to ICH guidelines in terms of accuracy, precision, linearity and robustness. Results: Bisoprolol Fumarate was separated in less than 4 minutes with good resolution and without any tailing effect or excipient interference. The limit of detection and the limit of quantification were 2.79 and 3.07 µg/mL, respectively. The relative standard deviation evaluated for the precision of the method was lower than 1%. Conclusions: The HPLC method developed for the determination of Bisoprolol Fumarate in a novel sustained release tablet formulation was specific and simple and it could also be used for in vitro studies.
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in vitro testing of xanthan lignin hydrogels as carriers for controlled delivery of Bisoprolol Fumarate
Revista medico-chirurgicală̆ a Societă̆ţ̜ii de Medici ş̧i Naturaliş̧ti din Iaş̧i, 2015Co-Authors: Irina Elena Răschip, Alina Diana Panainte, Daniela Pamfil, Lenuta Profire, Cornelia VasileAbstract:Aim To develop sustained release matrix tablets based on xanthan as highly water-soluble, cost-effective, non-toxic, easily available, and suitable hydrophilic systems. Material and methods Xanthan and lignin epoxy-modified resin (LER) mixture were crosslinked using epichlorohydrin as crosslinking agent leading to superabsorbent hydrogels with high swelling rate in aqueous mediums. Results and conclusions These hydrogels were tested as carries by the loading/delivery behaviour of Bisoprolol Fumarate in physiological conditions and based on the obtained results these hydrogels may show interest for application in medical and pharmaceutical areas. The amount of drug loaded in polymer networks was found to be ranging between 14.4% and 19.2%. Drug release was retarded and the release mechanism of the active principle was found to depend on matrix composition.
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IN VITRO TESTING OF XANTHAN/LIGNIN HYDROGELS AS CARRIERS FOR CONTROLLED DELIVERY OF Bisoprolol Fumarate.
Revista medico-chirurgicala a Societatii de Medici si Naturalisti din Iasi, 2015Co-Authors: Irina Elena Răschip, Alina Diana Panainte, Daniela Pamfil, Lenuta Profire, Cornelia VasileAbstract:Aim To develop sustained release matrix tablets based on xanthan as highly water-soluble, cost-effective, non-toxic, easily available, and suitable hydrophilic systems. Material and methods Xanthan and lignin epoxy-modified resin (LER) mixture were crosslinked using epichlorohydrin as crosslinking agent leading to superabsorbent hydrogels with high swelling rate in aqueous mediums. Results and conclusions These hydrogels were tested as carries by the loading/delivery behaviour of Bisoprolol Fumarate in physiological conditions and based on the obtained results these hydrogels may show interest for application in medical and pharmaceutical areas. The amount of drug loaded in polymer networks was found to be ranging between 14.4% and 19.2%. Drug release was retarded and the release mechanism of the active principle was found to depend on matrix composition.
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SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF Bisoprolol Fumarate IN TABLETS
Revista medico-chirurgicala a Societatii de Medici si Naturalisti din Iasi, 2014Co-Authors: Alina Diana Panainte, Madalina Vieriu, Gladiola Tantaru, Mihai Apostu, Bibire N, DorneanuAbstract:SPECTROPHOTOMETRIC METHODS FOR ESTIMATION OF Bisoprolol Fumarate IN TABLETS (Abstract): Bisoprolol Fumarate is prescribed for the treatment of hypertension and angina pectoris. Aim: The purpose of this study was to develop a simple, sensitive, accurate, and reproducible method for estimation of Bisoprolol Fumarate in tablets. Material and methods: The proposed method was based on a yellow colored complex formed with tropaeolin 00, extractable in dichloromethane with maximum absorbance at 412 nm. The method was validated statistically. Results: The linearity domain was observed in the concentration of 5-30 µg/ml. The recovery studies confirmed the accuracy of the proposed method. Conclusions: The proposed method can be applied for the routine analysis of Bisoprolol from formulations. Keywords: Bisoprolol Fumarate, SPECTROPHOTOMETRIC METHOD, TROPAEOLIN 00. Bisoprolol is a β blocker cardiovascular drug. It is structurally similar to metoprolol, acebutolol and atenolol in that it has two substituents in the para position of the benzene ring (fig.1) which might be the reason for its β1-selectivity.
Yasuki Kihara - One of the best experts on this subject based on the ideXlab platform.
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head to head comparison of the heart rate variability between the Bisoprolol transdermal patch and Bisoprolol Fumarate tablet
Cardiovascular Therapeutics, 2018Co-Authors: Akinori Sairaku, Yukiko Nakano, Nobuo Shiode, Kazuyoshi Suenari, Nozomu Oda, Koichi Ono, Yasuki KiharaAbstract:AIM The Bisoprolol transdermal patch is a newly developed β-blocker designed to deliver its pharmaceutical ingredient through the skin surface. We aimed to compare the Bisoprolol transdermal patch and Bisoprolol Fumarate tablet using the heart rate variability (HRV). METHOD Eligible hypertensive patients received a 2-week administration with a 2.5 mg Bisoprolol Fumarate tablet, followed by 24-hour Holter monitoring. The tablet was then switched to a 4 mg Bisoprolol transdermal patch, and after 2 weeks of its administration, the Holter monitoring was repeated. Both drugs were given once daily. Endpoint was any alteration in the HRV caused by a change in the administration route for Bisoprolol. RESULTS There was no difference in the 24-hour time-domain and frequency-domain HRV measurements before and after the drug switching among patients recruited (N = 30). However, the switching significantly altered the time-course curves of the hourly HRV measurements, including the mean normal-to-normal (NN) interval (P = .004), standard deviation of the NN index (P < .001), high frequency component (P = .01), and low frequency component (P = .003). Those alternations were attributed to the slower heart rate and more decreased short-term autonomic fluctuation resulting from the administration of the Bisoprolol transdermal patch, which were observed later than 12 hours after the drug initiation. No adverse events were noted throughout the study period. CONCLUSION The pattern of the autonomic modulation may vary depending on either a transdermal or oral administration even though an equivalent dose of Bisoprolol is given.
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Head‐to‐head comparison of the heart rate variability between the Bisoprolol transdermal patch and Bisoprolol Fumarate tablet
Cardiovascular therapeutics, 2018Co-Authors: Akinori Sairaku, Yukiko Nakano, Nobuo Shiode, Kazuyoshi Suenari, Nozomu Oda, Koichi Ono, Yasuki KiharaAbstract:AIM The Bisoprolol transdermal patch is a newly developed β-blocker designed to deliver its pharmaceutical ingredient through the skin surface. We aimed to compare the Bisoprolol transdermal patch and Bisoprolol Fumarate tablet using the heart rate variability (HRV). METHOD Eligible hypertensive patients received a 2-week administration with a 2.5 mg Bisoprolol Fumarate tablet, followed by 24-hour Holter monitoring. The tablet was then switched to a 4 mg Bisoprolol transdermal patch, and after 2 weeks of its administration, the Holter monitoring was repeated. Both drugs were given once daily. Endpoint was any alteration in the HRV caused by a change in the administration route for Bisoprolol. RESULTS There was no difference in the 24-hour time-domain and frequency-domain HRV measurements before and after the drug switching among patients recruited (N = 30). However, the switching significantly altered the time-course curves of the hourly HRV measurements, including the mean normal-to-normal (NN) interval (P = .004), standard deviation of the NN index (P