Search results for "Pharmaceutical Solutions"
showing 10 items of 14 documents
A novel technique for intraduodenal administration of drug suspensions/solutions with concurrent pH monitoring applied to ibuprofen formulations
2019
Characterization of dissolution of solid suspended drug particles in vivo is important for developing biopredictive in vitro tests. Therefore, methods to gain deeper insights into particle dissolution in vivo are needed. The soft Bioperm intubation method, a well established tool for investigation of permeability, absorption, metabolism, and drug interactions at predefined locations in the gastroinstinal tract, was modified. The novel intubation method involved pump-controlled infusion of pharmaceutical suspensions as well as simultaneous pH monitoring. This technique was used in a proof of concept study in healthy humans. Plasma sampling and non-compartmental analysis allowed comparison of…
Phase 1B Study of the Pharmacokinetics and Safety of Posaconazole Intravenous Solution in Patients at Risk for Invasive Fungal Disease
2014
ABSTRACT This was a phase 1B, dose-ranging, multicenter, pharmacokinetics, and safety study of cyclodextrin-based posaconazole intravenous (i.v.) solution administered through a central line to subjects at high risk for invasive fungal disease (part 1 of a 2-part study [phase 1B/3]). Initially, the safety and tolerability of single-dose posaconazole i.v. 200 mg ( n = 10) were compared with those of a placebo ( n = 11). Subsequently, 2 doses were evaluated, posaconazole i.v. 200 mg once daily (q.d.) ( n = 21) and 300 mg q.d. ( n = 24). The subjects received twice-daily (b.i.d.) posaconazole i.v. on day 1, followed by 13 days of posaconazole i.v. q.d., then 14 days of posaconazole oral suspen…
Patient and physician views on the quality of care in inflammatory bowel disease: Results from SOLUTION-1, a prospective IG-IBD study
2014
Remarkable differences in quality of care (QoC) might be observed in different countries, affecting quality of life of inflammatory bowel disease (IBD) patients. The aim of this study was to assess patient and physician perceptions of the QoC in Italy.A multicentre observational study on the quality of care in IBD (SOLUTION-1) was conducted in 36 IG-IBD (Italian Group for Inflammatory Bowel Disease) centres in Italy. The QUOTE-IBD (Quality of Care Through the Patient's Eyes) questionnaire was administered to IBD patients and to the attending physicians. The Quality Impact (QI) score summarises the QUOTE-IBD questionnaire, and a QI9 is considered satisfactory.Nine-hundred-ninety-two patients…
Three simultaneous dissolution profiles on a solid pharmaceutical formulation by a FIA manifold provided with a single spectrophotometric detector.
2003
This article deals with the simultaneous determination of three dissolution profiles in the same pharmaceutical formulation. The officially proposed procedure from the pharmacopoeias is adapted to the FIA methodology to obtain the officially recommended profile or "global profile", and two "individual" profiles, corresponding to dissolution rate of two different active principles present in the formulation; both drugs have overlapped UV-vis spectra. The simultaneous determination of several profiles is based on the derivative spectra and the zero crossing mathematical procedure for the "individual" profiles of an active principle; the "global" profile of the formulation is obtained from the…
Stability of tacrolimus ophthalmic solution
2017
Purpose The stability of 0.3-mg/mL tacrolimus ophthalmic solution at different storage temperatures was studied. Methods A sterile ophthalmic solution of 0.3 mg/mL tacrolimus was prepared in triplicate under aseptic conditions by diluting tacrolimus in eye drops. Three aliquots of this solution were transferred into polypropylene bottles and stored at 25, 2–8, or −15 to −25 °C. Samples were collected immediately after preparation and at selected time points and assayed in triplicate using high-performance liquid chromatography (HPLC). Samples were also visually examined for macroscopic changes. The 0.3-mg/mL tacrolimus solution was also exposed to acidic treatment and heat to force its degr…
Physico-chemical stability of eribulin mesylate containing concentrate and ready-to-administer solutions.
2013
Objectives The aim of this study was to determine the stability of commercially available eribulin mesylate containing injection solution as well as diluted ready-to-administer solutions stored under refrigeration or at room temperature. Methods Stability was studied by a novel developed stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) assay with ultraviolet detection (detection wavelength 200 nm). Triplicate test solutions of eribulin mesylate containing injection concentrate (0.5 mg/mL) and with 0.9% sodium chloride solution diluted ready-to-administer preparations (0.205 mg/mL eribulin mesylate in polypropylene (PP) syringes, 0.020 mg/mL eribulin mesyl…
Effects of Ethanol to Water Ratio in Feed Solution on the Crystallinity of Spray-Dried Lactose
2002
In the present study, the effects of ethanol to water ratio in feed solution on the physical properties of spray-dried alpha-lactose monohydrate were evaluated. Crystallinity of the spray-dried lactose was determined by isothermal microcalorimetry (IMC) and by differential scanning calorimetry (DSC). Water content of the spray-dried lactose was determined by thermogravimetric analysis and the surface area was evaluated by Brunauer, Emmett, and Teller (BET) method. The crystallinity of spray-dried lactose varied from 0% to 100%, depending on the ratio of ethanol to water in the feed solution. Lactose spray dried from pure ethanol was 100% crystalline and contained hydrate water. Lactose spra…
In-use physicochemical and microbiological stability of biological parenteral products
2015
Pharmaceutical scientists in the biotechnology industry have traditionally focused on achieving acceptable shelf lives of drug products in their original, unopened product unit configuration (e.g., two years stored at 2–8 °C). However, it is now clear that stability considerations extend beyond
Physicochemical compatibility of mixtures of dornase alfa and tobramycin containing nebulizer solutions
2008
Patients suffering from cystic fibrosis (CF) often need to inhale multiple doses of different nebulizable drugs per day. Patients attempt to shorten the time consuming administration procedure by mixing drug solutions/suspensions for simultaneous inhalation. The objective of this experimental study was to determine whether mixtures of the nebulizer solution dornase alfa (Pulmozyme) with tobramycin nebulizer solutions (TOBI and GERNEBCIN 80 mg) are physico-chemically compatible. Drug combinations were prepared by mixing the content of one respule Pulmozyme with either one respule TOBI or one ampoule GERNEBCIN 80 mg. Test solutions were stored at room temperature and exposed to light. Dornase…
Physicochemical compatibility and stability of nebulizable drug admixtures containing Dornase alfa and tobramycin.
2012
The objective of this in-vitro study was to determine whether admixtures of the inhalation solutions Pulmozyme(®) (Dornase alfa) and either Bramitob(®) or Tobi(®) (both containing Tobramycin) are physicochemically compatible and to analyze the aerodynamic parameters of these admixtures. After mixing, test solutions were stored at room temperature and under ambient light conditions over a period of 24 h. Tobramycin concentrations were determined by using a fluorescence immunoassay. Stability of dornase alfa was determined by size-exclusion high performance liquid chromatography, ultraviolet spectroscopy, sodium dodecyl sulfate polyacrylamide gel electrophoresis and tentacle strong cation-exc…