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Pharmacodynamic Equivalence of Ovine Enoxaparin to Porcine Enoxaparin (Lovenox®) In Healthy Volunteers: A Randomized, Open-Label, 2-Way Cross-Over, Single Dose Study

Aim: to demonstrate the PK/PD equivalence of an ovine enoxaparin to the reference product, the originator porcine enoxaparin, Lovenox® from Sanofi, and to assess its safety and tolerability in healthy volunteers with s.c. administration. Methods: a randomized, open-label, 2-way cross-over, single-dose study with 7 days wash-out period was conducted in healthy volunteers of both sexes. A single s.c. injection of 6,000 IU ovine enoxaparin from Metiska Farma (the test drug, T) or Lovenox® from Sanofi (the reference drug, R) was given randomly to each subject in fasting condition. The PD endpoints measured were anti-FXa and anti-FIIa activities in plasma, whereas the PD parameters determined for these endpoints were AUEC0-t (area under the effect curve from time 0 to the last measured activity (t)) and Amax (maximum activity). Bioequivalence (BE) is based on anti-FXa activity, the 90% CIs for GMR T/R (geometric means ratio of Test/ Reference) of AUEC0-t and Amax must fall within the BE limits of 80.00 – 125.00%. The anti-FIIa data are in vivo supportive evidence only. Results: a total of 23 healthy volunteers completed this study. The 90% CIs for GMR T/R of AUEC0-t and Amax for anti-FXa were 107.55 – 116.33% and 110.17 – 117.68%, respectively, while those for anti-FIIa were 100.93 – 122.56% and 105.19 – 124.44%, respectively. All parameters fell within the BE criteria of 80.00 – 125.00%. One AE (adverse event) occurred in one volunteer after s.c. injection of ovine enoxaparin, i.e. bruising which disappeared after a few days. Conclusions: the ovine enoxaparin from Metiska Farma was bioequivalent to the reference porcine enoxaparin (Lovenox®) from Sanofi. Both enoxaparin products were shown to have high safety and tolerability after a single dose in healthy volunteers. This is the first study showing BE of a nonporcine enoxaparin to the reference porcine enoxaparin in Indonesia, a Moslem country
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A Review on Veterinary Medical Waste Disposal and Management

The purpose of this review is to highlight environmentally sound disposal methods of veterinary pharmaceutcals wastes and the risks associated with its improper disposal, with a systematic review. Pharmaceuticals are produced and used in large volumes increasingly every year throughout the world. Medicinal waste products are medicinal products which are not fit for sale or supply. Waste produced in veterinary practice in common with other medical disciplines can be broken down into general waste similar to household waste, clinical waste and hazardous waste. Disposal of pharmaceutical compounds is becoming a complex environmental issue. The safety and health of the environment is directly affected by the disposal methods. Improper medical waste disposal and management causes all types of pollution (air, soil, and water). Proper waste management have to be undertaken to ensure that it does not affect the environment and not cause health hazards to the people living there. Different types of medical waste require different disposal techniques. The appropriate safe disposal method recommended will depend principally on the pharmaceutical dosage form of the drugs. One of the best advisable veterinary waste disposal practices is to store the waste properly before collection and transportation. Some general medical waste can be disposed of in landfill, others require specialist treatment such as a medical incinerator. Appropriate safety precautions, which minimize the risk to the health and safety of pharmacy staff, should be taken when handling medicinal waste products. Extra precautions should be taken by staff in high-risk groups as they may be at increased risk if they come into contact with particular substances. The cost of pharmaceuticals waste disposal comprises of direct costs of supplies and materials used for collection, transport, storage, treatment, disposal, decontamination and cleaning, the cost of labor and material for training and maintenance, and will vary depending on the treatment method chosen, the capacity of the treatment facility and according to the waste quantity and quality.
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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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Potential COVID-19 Therapeutics: A Perspective on Pharmacological Properties and Safety

There are no guidelines for pharmacological treatment of COVID-19 disease, but several drugs are being tested every day in search of an optimal therapeutic strategy. The drugs that have been tested, so far, include some antiviral drugs such as danoprevir, favipiravir, darunavir, nelfinavir, remdesivir, umifenovir and the combination lopinavir/ritonavir. Others are drugs targeting inflammatory mediators such as meplazumab, siltuximab, tocilizumab, azithromycin and corticosteroids. Also included in this array of tested drugs are those with pleiotropic actions against SARS-CoV-2 infection like chloroquine/hydroxychloroquine, ivermectin and nitazoxanide, postulated as inhibitors of several phases of virus life cycle. Upon diagnosis of SARS-CoV-2 infection, it is pertinent to embark on a treatment approach based on potential antiviral options, adequately managed under proper medical situation. We suggest that, in addition to the antiviral option efforts, drugs targeting inflammatory mediators should be considered.
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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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How Nurse Education Impacts Her Career?

A great proportion of healthcare services need high-quality medication and nursery. For high-quality nursery needs best nurses and their education. Gradually, different types of nursery education systems can impact their life and career. In the future, more parameters can be used for judging the quality and promotion of nurses. This editorial addresses different educational efforts for their progresses in medical knowledge promotion, technical capability improvement and salary promotion.
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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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Pharmacokinetics Bridging Study of a 400 Mg Extended Release Formulation of the Novel Fumaric Acid Ester PPC-06 (Tepilamide Fumarate) in Healthy Male Volunteers

Tepilamide fumarate (PPC-06) is a new, patented prodrug of monomethyl fumarate (MMF), belonging to the fumaric acid esters (FAEs) class of drugs. The efficacy and safety of a 400 mg PPC-06 dose administered twice daily, achieved thus far through concomitant intake of two tablets of 200 mg, was demonstrated previously in two Phase 2 clinical trials on patients with moderate to severe chronic plaque-type psoriasis.
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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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Charles Bonnet Syndrome: Rapid Resolution of Visual Hallucinations with Low Dose Risperidone

Charles Bonnet syndrome (CBS) comprises of complex visual hallucinations secondary to visual impairment in the presence of preserved cognition. Age related macular degeneration and other factors causing visual deterioration lead to visual hallucinations in 10-15% of patients. Sensory deprivation and social isolation are risk factors for development of CBS. The distressing hallucinations are underreported by patients and to date there are no robust evidence based guidelines to manage these hallucinations. Since visual hallucinations are associated with multiple psychiatric disorders as well, these patients are often referred to mental health providers. Here, we present the case of CBS development after macular degeneration. Rapid and sustained resolution of visual hallucinations and associated distress was observed with low dose Risperidone.
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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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Editorial Board Members Related to Pharma

Sue Hudson Duran

Professor
Auburn University
United States

FRANCISCO FERNANDEZ CAMPOS

Professor Adjuant
Department of Pharmaceutical Technology
University of Barcelona
Spain

A. F. M. Motiur Rahman

Associate Professor
Department of Pharmaceutical Chemistry
College of Pharmacy, King Saud University
Saudi Arabia

Huangui Xiong

Professor
Department of Pharmacology and Experimental Neuroscience
University of Nebraska Medical Center
United States

N. S. NEKI

Professor of Medicine
Government Medical College and Guru Nanak Dev Hospital
Amritsar
India

Antoine Trzcinski

Lecturer in Water and Environmental Engineering
Faculty of Engineering
University of Southern Queensland
Australia

Chi-Rei Wu

Associate Professor
Department of Chinese pharmaceutical sciences
China medical university
China

BADER MUBARAK W. AL-JAEID

Faculty of Pharmacy
King Abdulaziz University
Saudi Arabia

SANJEEV KUMAR SINGH

Professor
Department of Bioinformatics
Alagappa University
India

David Ilki Min

Professor
Pharmacy Practice and Administration
Western University of Health Sciences
United States
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