Articles Related to Pharma

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.

View complete article: PDF  |  Full-text

In literature are reported various use of activated charcoal AC and derivates in biopharmaceutical purifications.Aim of this work is to verify impurity proficle when using this technology.Various commercial products are reported here but it is not the scope of this work put in relation with any toxicological reaction: only to describe the technique used in this field.Because various drugs and bioproduct need purification steps it is if of interest to see some material science peculiarity

View complete article: PDF  |  Full-text

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

View complete article: PDF  |  Full-text

Proper use of medicine or taking medicine in correct order is essential to cure any disease. According to the WHO, lack of adherence to treatment regimens leads to major problems among patients, mostly with chronic illnesses

View complete article: PDF  |  Full-text

View complete article: PDF  |  Full-text

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

View complete article: PDF  |  Full-text

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.

View complete article: PDF  |  Full-text

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.

View complete article: PDF  |  Full-text

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.

View complete article: PDF  |  Full-text

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,

View complete article: PDF  |  Full-text

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.

View complete article: PDF  |  Full-text

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.

View complete article: PDF  |  Full-text

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.

View complete article: PDF  |  Full-text

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.

View complete article: PDF  |  Full-text

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.

View complete article: PDF  |  Full-text