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Comparison of Physicochemical and Binding Properties of Novicel™ Microcrystalline Cellulose and Avicel® PH 101 in Direct Compression of Ascorbic Acid Tablets

Microcrystalline cellulose (MCC) is a key excipient in formulation and production of pharmaceutical solid dosage forms such as tablets. In this study, the microcrystalline cellulose (Novicel™) obtained from sugarcane bagasse (a waste material from sugarcane factories) was compared with Avicel PH 101 (a commercially available MCC) for its physicochemical characteristics and potential as a dry binder in direct compression of ascorbic acid tablets.
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Bioequivalence Studies of Two Formulations of Rivaroxaban 10 Mg Coated Tablets under Fasting Conditions and 20 Mg Coated Tablets Under Fed and Fast Conditions And its Pharmacokinetic Comparison In Healthy Subjects

Justificative: This trial was conducted in order to register a new generic product of Rivaroxaban. Objective: To evaluate the bioequivalence of rivaroxaban formulations manufactured by Eurofarma Laboratórios S/A and the reference drug, Xarelto (Bayer) under fasting and fed conditions. Methods: Three randomized, open label, balanced, 2 treatments, 4 periods, 2 sequences, single dose, full replicate, crossover studies in 48 healthy adult human subjects under fed and fasting conditions for rivaroxaban 10 mg and 20 mg. Rivaroxaban concentrations in plasma were determined using a validated HPLC-MS/MS method.
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A Bioequivalence Study of Two Formulations of Lacosamide

This study was conducted to compare the bioavailability of two tablet formulations containing 200 mg Lacosamide (one Lacosamide 200 mg film-coated tablet marketed in Italy as Ollat®, one Vimpat® coated tablet). 20 healthy subjects were enrolled in a single-center, randomized, single-dose, laboratory-blinded, 2-period, 2-sequence, crossover study, with a minimum washout period of 7 days. All the 20 subjects completed the study. Plasma samples were collected up to 72.0 hours post-dosing. Lacosamide levels were determined using a validated high-performance liquid chromatography with tandem mass spectrometry (HPLC/MS/MS) method
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Bioequivalence Study of Two 80 Mg Valsartan Tablets Formulations in Healthy Chinese Subjects Under Fasting and Fed Condition

Objective: The purpose of this study was to compare the bioavalability between the two 80 mg Valsartan Tablets formulations and to evaluate the bioequivalence of Reference and Test formulations of Valsartan Tablets 80 mg in Healthy adult chinese Male and Female subjects under Fasting and Fed condition.
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Randomised, 2-Sequence, 4-Period Replicate Cross-Over Bioequivalence Study of A New Riluzole Orodispersible Film Vs. A Reference Tablet in Healthy Volunteers

Purpose: The present bioequivalence study aimed at demonstrating the bioequivalence of a recently developed novel riluzole orodispersible film vs. a reference tablet. Methods: Healthy male and female volunteers received single oral doses of 50 mg of riluzole, as test and reference formulation, under fasting conditions, in each of 4 subsequent periods separated by wash-out intervals of at least 7 days, according to a 2-treatment, 4-period, replicate randomised cross-over design. Findings: Riluzole plasma concentrations were almost superimposable. Riluzole attained a similar peak concentration (315.62±124.95 ng/mL with the film and 278.81±123.32 ng/mL with the tablet) at a median tmax of 0.75 h after both treatments. Then, riluzole plasma concentrations showed a superimposable decline from the peak up to 36 h post-dose, with mean half-lives of 10.22±1.66 and 10.22±1.48 h with the film and the tablet. Mean AUC0-t was 1263.40±571.58 h*ng/mL with the film and 1135.98±514.98 h*ng/mL with the tablet. The 90% confidence intervals of Cmax, AUC0-t and AUC0-¥ of riluzole fell within the predefined range 80.00-125.00%. The treatments did not differ significantly either in tmax or t1/2. On average, the test orodispersible film dissolved on the tongue in a median time of about 2.5 min with a range of 0.7-5.7 min. Orodispersible film palatability was good or acceptable for most subjects.
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Stability Indicating Method Development and Validation for the Determination of Armodafinil in Pharmaceutical Tablet Dosage Form by RP-HPLC

The present research deals with the development of a stability indicating reverse phase HPLC with PDA detector method for the determination of Armodafinil Agilent XDB-C18, 150×4.6mm, 5µm or Equivalent column. The present research deals with the development of a stability indicating reverse phase HPLC with PDA detector method for the determination of Armodafinil Agilent XDB-C18,
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Bioequivalence Study of Donepezil 10 mg Orally Disintegrating Tablets in Healthy Thai Volunteers Under Fasting Conditions

Donepezil is a potent, selective, noncompetitive and reversible inhibitor of acetylcholinesterase, commonly used for the treatment of Alzheimer’s disease. The form of orally disintegrating tablets (ODTs) is a good alternative dosage form for patients who have a difficulty in swallowing conventional tablets or capsules.
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Comparative Bioequivalence Studies of Pantoprazole 40 mg Delayed-Release Tablet Formulations in Healthy Thai Volunteers

Pantoprazole is a H+,K+-ATPase enzyme inhibitor for the treatment of acid-related gastrointestinal diseases. The Government Pharmaceutical Organization (GPO), Thailand had developed Pantoprazole GPO® (pantoprazole 40 mg delayed-release tablets) as a generic substitute for the corresponding innovator product, CONTROLOC® 40 mg.
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Bioequivalence of Two Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate 600/200/300 mg Fixed-Dose Combination Tablets in Healthy Thai Male Volunteers under Fasting Conditions

Fixed-dose combination tablet formulation of efavirenz/emtricitabine/tenofovir disoproxil fumarate 600/200/300 mg is an antiretroviral therapy comprising one non-nucleoside reverse-transcriptase inhibitor and two nucleoside reverse-transcriptase inhibitors to control human immunodeficiency virus infection.
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Bioequivalence Evaluation of Two Clopidogrel Immediate Release Tablet Formulations in Healthy Thai Volunteers Under Fasting Conditions

Clopidogrel is used for acute coronary syndrome and prevention of atherothrombotic events. To improve clinical outcomes, patient adherence to treatment is necessary. However, continuous use of branded product may cause economic burden to patients and healthcare system. The Government Pharmaceutical Organization (GPO), Thailand had developed a generic product of clopidogrel to reduce cost of treatment and improve accessibility to medicines for Thai people.
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Bioequivalence between Two Tablets of Levetiracetam in Healthy Subjects under Fasting Condition

Bioavailability of two formulations containing levetiracetam 750 mg film-coated tablets was compared in a fasting bioequivalence study. The study was single dose, randomized, open label, and two-period crossover, with Brazilian healthy subjects, males and nonpregnant females. Blood samples were taken for 36 hours after drug administration and plasmatic concentrations were determined using a validated HPLC-MS/MS method. Confidence intervals (CI90%) for the peak plasma concentration (Cmax) and area under the concentration-time curve (AUC0-t) were determined by calculating LN-transformed data. The ratios and 90% CI for the geometric mean test/reference were 97.41% (91.45- 103.75%) for Cmax and 99.77% (97.07- 102.54%) for AUC0-t.
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Bioequivalence Study of Olanzapine 5 mg Orally Disintegrating Tablet Formulations in Healthy Thai Volunteers under Fasting Conditions

A comparative randomized, single dose, two-way crossover, open label study was carried out to assess bioequivalence and tolerability of test (ZOLAN GPO®) and reference (Zyprexa Zydis®) products of olanzapine 5 mg orally disintegrating tablets for interchange ability in the same quality and safety.
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A Bioequivalence Study of Two Formulations of Rosuvastatin

Aim of this study was to compare the bioavailability of two tablet formulations containing Rosuvastatin: Rosuvastatin tablets 40 mg manufactured by MacLeods Pharmaceuticals Ltd. (marketed in Italy with the brand name Exorta®) and CRESTOR® 40 mg tablets marketed by Astra Zeneca.
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A Bioequivalence Study of Two Formulations of Levetiracetam

This study was conducted to compare the bioavailability of 1000 mg levetiracetam film-coated tablet, marketed in Italy as Italept®, with Keppra® coated tablet.
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Bioequivalence between two extended Release Tablets of Oxycodone Hydrochloride in Healthy Subjects under Fasting and Fed Conditions

Bioavailability of different formulations of oxycodone 20 mg extended release tablets was compared in two bioequivalence studies, one under fasting conditions and the other one after a high-fat breakfast.
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Editorial Board Members Related to tablet

KETAN VINODLAL SHAH

Associate Professor
School of Pharmacy
RK University
India

ALAA EL-DEEN BAKRY YASSIN

Associate Professor
Department of Pharmaceutical Sciences
King Saud bin Abdulaziz University for Health Sciences
Saudi Arabia

TIMUCIN UGURLU

Associate Professor
Department of Pharmaceutical Technology
Marmara University
Turkey

Khalid M. El-Say

Associate professor
Department of Pharmaceutics and Industrial pharmacy
King Abdulaziz University
Saudi Arabia

NORMA RANGEL

Professor Research
Division of Graduate Studies and Research
Institute of Technology Aguascalientes (ITA)
Technological Institute of Aguascalientes (ITA)
Mexico
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