Search results for "Mace"

Application of LA-ICP-MS as a rapid tool for analysis of elemental impurities in active pharmaceutical ingredients.

2014

The control of inorganic contaminants in active pharmaceutical ingredients has a significant role in the quality control of drug products. The concentration limits for metal residues in drug products have been defined by various regulatory guidelines. Laser ablation inductively coupled plasma mass spectrometry (LA-ICP-MS) is a powerful and fast analytical technique for multi-elemental analysis. A disadvantage in using LA-ICP-MS method is the lack of matrix reference materials for validation and calibration purposes. This article focuses on the handling strategy of laboratory-made matrix calibration standards for the quantification of elemental impurities in an active pharmaceutical ingredie…

Trehalose-hydroxyethylcellulose microspheres containing vancomycin for topical drug delivery.

2001

Abstract A new formulation, in which vancomycin is entrapped into trehalose and hydroxyethylcellulose (Natrosol ® ) spherical matrices, is described. Microspheres were produced by the solvent evaporation method. The entrapped drug was fully recovered following microspheres dissolution. Differential scanning calorimetry analyses proved that Natrosol maintains trehalose in its amorphous form. The stabilizing effects of trehalose on vancomycin were evaluated even after long storage and heating of microspheres. Calorimetric data indicated no decomposition of the entrapped drug. In vitro drug release, already performed by using a general two-compartment linear time-invariant open model, suggests…

Pefloxacine mesilate- and ofloxacin-loaded polyethylcyanoacrylate nanoparticles: characterization of the colloidal drug carrier formulation.

1995

The entrapment of fluoroquinolones, perfloxacine mesilate (PFX) and ofloxacin (OFX), in polyalkylcyanoacrylate (PECA) nanoparticles could offer some advantages for their biological application; for examples, increasing their bioavailability, controlling the drug time-release in blood, and reducing the formation of bacterial resistance. To load these two drugs in PECA polymeric bulk, the incorporation or adsorption method was performed. These two methods were capable of influencing nanoparticle size, molecular weight, release profile, and drug–polymer association. The incorporation method, particularly for the OFX system, achieved PECA nanoparticle suspensions with a mean size value three ti…

The impact of the EMA change in definition of "dose" on the BCS dose-solubility ratio: a review of the biowaiver monographs.

2013

The Biopharmaceutics Classification System (BCS) defines the solubility characteristics of an active pharmaceutical substance based on its dose-solubility ratio: for highly soluble drugs this ratio is less than 250 mL over a defined pH range. Prior to the revision of the European Medicines Agency (EMA, formerly EMEA) guideline in 2010, the "dose" in this ratio was consistently defined by the US FDA, the EMA, and the WHO biowaiver guidelines as the highest dosage strength. However, in the revised EMA guideline, the dose is defined as the highest single dose administered according to the Summary of Product Characteristics. The new EMA criterion for highly soluble may be closer to the actual c…

2006

Trends in individual reimbursement of orphan drugs in Latvia in 2008–2011

2014

Orphan drugs (ODs) are medicinal products intended for diagnosis, prevention or treatment of life-threatening or very serious diseases affecting less than 5 in 10 000 people in the European Union (EU). These drugs are called “orphans” because the pharmaceutical industry has little interest, under normal market conditions, in developing and marketing products intended for only a small number of patients suffering from very rare conditions. Because of the small market, ODs are often very expensive. Whereas decisions surrounding orphan designation and marketing authorization of ODs are taken at the EU level, decisions governing pricing and reimbursement of ODs are a member state responsibility…

OHP-041 Formulary Decision-Making For Biosimilars: Considerations For Hospital Pharmacists

2013

Background It has been 6 years since the first biosimilar was approved for use in the European Union (EU). Given the likelihood that biosimilar monoclonal antibodies will be approved in Europe in the near future, it is timely to review the formulary selection criteria for biologicals and biosimilars. The European Medicines Agency (EMA) has issued guidelines that define the regulation of biosimilars in Europe and recommend approaches to establish biosimilarity. However, several questions regarding the assessment of biosimilars for formulary inclusion remain unanswered, including those related to manufacturing and drug supply. Purpose To aid hospital pharmacists in developing evaluation crite…

Targeted-lung delivery of dexamethasone using gated mesoporous silica nanoparticles. A new therapeutic approach for acute lung injury treatment

2021

Acute lung injury (ALI) is a critical inflammatory syndrome, characterized by increased diffuse inflammation and severe lung damage, which represents a clinical concern due to the high morbidity and mortality in critical patients. In last years, there has been a need to develop more effective treatments for ALI, and targeted drug delivery to inflamed lungs has become an attractive research field. Here, we present a nanodevice based on mesoporous silica nanoparticles loaded with dexamethasone (a glucocorticoid extensively used for ALI treatment) and capped with a peptide that targets the TNFR1 receptor expressed in pro-inflammatory macrophages (TNFR-Dex-MSNs) and avoids cargo leakage. TNFR-D…

Analgetische Wirkstoffe, 11. Mitt. Diacylderivate des Butyroguanamins

1986

Die Synthese vono-Acylamino-β-dimethylamino-propiophenonen. 4. Mitt.: Synthese der primären Mannich-Basen

1972

Das durch Umsetzung von 2-Acetamino-β-dimethylamino-propiophenon (IVb) mit Dibenzylamin darstellbare 2-Acetamino-β-dibenzylamino-propiophenon (XXVII) kann hydrogenolytisch mit tels Palladium-Aktivkohle in die entsprechende, nur am aromatischen Stickstoff acetylierte primare Mannich-Base ubergefuhrt werden. In analoger Weise sind auch in 5-Stellung substituierte Derivate des 2-Acetamino-β-amino-propiophenons (XXVIII) zuganglich. Synthesis of 2-Acylamino-β-amino-propiophenones 2-Acetamino-β-dibenzylamino-propiophenone (XXVII) and its derivatives, substituted in 5-position, can be synthetized by reaction of 2-acetamino-β-dimethylamino-propiophenone (IVb) with dibenzylamine. By hydrogenolysis i…