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Journal of Pharmacy & Pharmaceutical... 2006The pharmacist, both in community and hospital pharmacy practice, is often challenged with the preparation of a liquid dosage form not available commercially for... (Review)
Review
The pharmacist, both in community and hospital pharmacy practice, is often challenged with the preparation of a liquid dosage form not available commercially for paediatric patients, those adults unable to swallow tablets or capsules and patients who must receive medications via nasogastric or gastrostomy tubes. Recognising the lack of information available to healthcare professionals, a general discussion of the various parameters that may be modified in preparing these dosage forms and a tabulated summary of the dosage forms presented in the literature is described, which, although not exhaustive, will provide information on the formulation and stability of the most commonly prepared extemporaneous liquid dosage forms. An extensive survey of the literature and investigation of 83 liquid dosage forms revealed that stability considerations were of concern for only 7.2% of these liquid dosage forms, extemporaneously prepared from the following commercially available products: captopril, hydralazine hydrochloride, isoniazid, levothyroxine sodium, phenoxybenzamine hydrochloride and tetracycline hydrochloride. Inclusion of the antioxidant, sodium ascorbate in the liquid dosage form for captopril resulted in improved stability at 4 degrees C. Hydralazine hydrochloride, isoniazid and phenoxybenzamine hydrochloride were adversely affected due to interactions with excipients in the formulation, while the effect of the preservative in lowering the pH in a levothyroxine sodium mixture resulted in decreased stability. Interestingly, the instability in these formulations is primarily due to interactions between the drug substance and the excipients rather than degradation of the active pharmaceutical ingredient by standard routes such as oxidation, hydrolysis, photolysis or thermolysis. This low percentage however illustrates the low risk associated with these dosage forms investigated. It may be concluded that when considering the safety and efficacy of liquid dosage forms prepared extemporaneously, it is thus important to consider not only the stability of the drug substance but the entire formulation.
Topics: Dosage Forms; Drug Compounding; Drug Stability; Humans; Pharmaceutical Solutions; Pharmacists
PubMed: 17207422
DOI: No ID Found -
Drug Delivery Nov 2017The goal of the present study is to develop polymeric matrix films loaded with a combination of free diclofenac sodium (DFS) and DFS:Ion exchange resin complexes...
PURPOSE
The goal of the present study is to develop polymeric matrix films loaded with a combination of free diclofenac sodium (DFS) and DFS:Ion exchange resin complexes (DFS:IR) for immediate and sustained release profiles, respectively.
METHODS
Effect of ratio of DFS and IR on the DFS:IR complexation efficiency was studied using batch processing. DFS:IR complex, DFS, or a combination of DFS+DFS:IR loaded matrix films were prepared by melt-cast technology. DFS content was 20% w/w in these matrix films. In vitro transcorneal permeability from the film formulations were compared against DFS solution, using a side-by-side diffusion apparatus, over a 6 h period. Ocular disposition of DFS from the solution, films and corresponding suspensions were evaluated in conscious New Zealand albino rabbits, 4 h and 8 h post-topical administration. All in vivo studies were carried out as per the University of Mississippi IACUC approved protocol.
RESULTS
Complexation efficiency of DFS:IR was found to be 99% with a 1:1 ratio of DFS:IR. DFS release from DFS:IR suspension and the film were best-fit to a Higuchi model. In vitro transcorneal flux with the DFS+DFS:IR(1 + 1) was twice that of only DFS:IR film. In vivo, DFS solution and DFS:IR suspension formulations were not able to maintain therapeutic DFS levels in the aqueous humor (AH). Both DFS and DFS+DFS:IR(3 + 1) loaded matrix films were able to achieve and maintain high DFS concentrations in the AH, but elimination of DFS from the ocular tissues was much faster with the DFS formulation.
CONCLUSION
DFS+DFS:IR combination loaded matrix films were able to deliver and maintain therapeutic DFS concentrations in the anterior ocular chamber for up to 8 h. Thus, free drug/IR complex loaded matrix films could be a potential topical ocular delivery platform for achieving immediate and sustained release characteristics.
Topics: Administration, Ophthalmic; Administration, Topical; Animals; Chemistry, Pharmaceutical; Delayed-Action Preparations; Diclofenac; Drug Delivery Systems; Eye; Ion Exchange Resins; Male; Ophthalmic Solutions; Organ Culture Techniques; Rabbits
PubMed: 28165833
DOI: 10.1080/10717544.2016.1256000 -
Journal of Diabetes Science and... Jan 2015A promising approach to treat diabetes is the development of fully automated artificial/bionic pancreas systems that use both insulin and glucagon to maintain...
A promising approach to treat diabetes is the development of fully automated artificial/bionic pancreas systems that use both insulin and glucagon to maintain euglycemia. A physically and chemically stable liquid formulation of glucagon does not currently exist. Our goal is to develop a glucagon formulation that is stable as a clear and gel-free solution, free of fibrils and that has the requisite long-term shelf life for storage in the supply chain, short-term stability for at least 7 days at 37°C, and pump compatibility for use in a bihormonal pump. We report the development of two distinct families of stable liquid glucagon formulations which utilize surfactant or surfactant-like excipients (LMPC and DDM) to "immobilize" the glucagon in solution potentially through the formation of micelles and prevention of interaction between glucagon molecules. Data are presented that demonstrate long-term physical and chemical stability (~2 years) at 5°C, short-term stability (up to 1 month) under accelerated 37°C testing conditions, pump compatibility for up to 9 days, and adequate glucose responses in dogs and diabetic swine. These stable glucagon formulations show utility and promise for further development in artificial pancreas systems.
Topics: Animals; Diabetes Mellitus, Experimental; Diabetes Mellitus, Type 1; Dogs; Drug Delivery Systems; Drug Stability; Female; Glucagon; Humans; Male; Pancreas, Artificial; Pharmaceutical Solutions; Swine
PubMed: 25352634
DOI: 10.1177/1932296814555541 -
European Journal of Hospital Pharmacy :... Sep 2020For newborn and preterm infants, standardised and individual parenteral nutrition (PN) is used. PN preparation is at risk for contamination and dosing errors. The...
BACKGROUND
For newborn and preterm infants, standardised and individual parenteral nutrition (PN) is used. PN preparation is at risk for contamination and dosing errors. The quality of PN is crucial for infants and has a direct impact on their health status and safety.
PURPOSE
The aim of this study is to evaluate the physicochemical and microbial quality of PN for newborn and preterm infants prepared on a neonatal ward.
METHODS
Sampling of various individual PN prepared by nurses on a neonatal ward was performed. Formulations included maximal four electrolytes, variable dextrose and amino acid concentrations. Depending on the sample volume, up to three quality analyses were performed: (1) test for bacterial endotoxins by kinetic-chromogenic method, (2) sterility according to the European and US Pharmacopoeia, and (3) quantification of electrolytes by capillary electrophoresis and of dextrose by ultraviolet detection after enzymatic reaction of hexokinase. The concentrations obtained were evaluated based on the US and Swiss Pharmacopoeia specifications for compounded preparations and compared to the widened pharmacy specifications.
RESULTS
The composition of 86% of the 110 analysed PN prepared by nurses on the neonatal ward corresponded to their medical prescription. 14% were out of the acceptable widened pharmacy ranges. We found no microbial contamination in the samples. All PN were free from endotoxins.
CONCLUSION
Component concentrations of PN prepared on wards by nurses differed frequently and significantly from their medical prescription, and the deviation can be critical depending on the component and its mode of action. The sample size is too small to evaluate the microbial contamination.
Topics: Drug Contamination; Electrophoresis, Capillary; Humans; Infant Health; Infant, Newborn; Infant, Premature; Nurse's Role; Parenteral Nutrition; Parenteral Nutrition Solutions; Quality Control
PubMed: 32839262
DOI: 10.1136/ejhpharm-2018-001788 -
Journal of the American Society of... Nov 2016
Topics: Hemodialysis Solutions; Renal Dialysis; Urea
PubMed: 27270443
DOI: 10.1681/ASN.2016040417 -
Brazilian Journal of Cardiovascular... Oct 2022Custodiol (histidine-tryptophan-ketoglutarate) and repetitive blood cardioplegia are the solutions for myocardial protection and cardiac arrest. In this study, we aimed... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Custodiol (histidine-tryptophan-ketoglutarate) and repetitive blood cardioplegia are the solutions for myocardial protection and cardiac arrest. In this study, we aimed to compare immunohistochemical analysis, clinical outcomes, and cardiac enzyme values of Custodiol and blood cardioplegia groups.
METHODS
This was a randomized prospective study consisting of 2 groups and 20 patients, 10 patients for each group, who underwent mitral and mitral/tricuspid valve surgery. Group 1 was formed for Custodiol cardioplegia and group 2 for blood cardioplegia. Perioperative and postoperative cardiac events were recorded, cardiac enzymes were analyzed with intervals, and myocardial samples were taken for immunohistochemical analysis. Recorded data were statistically evaluated.
RESULTS
There was no significant difference for the Custodiol and blood cardioplegia groups in perioperative and postoperative cardiac performance and adverse events. Cardiac enzyme analysis showed no significant difference between groups. However, two parameters (eNOS, Bcl-2) were in favor of the Custodiol group in immunohistochemical studies. Custodiol performed better in cellular oxidative stress resistance and cellular viability.
CONCLUSION
Clinical outcomes and cardiac enzyme analysis results were similar regarding myocardial protection. However, Custodiol performed better in the immunohistochemical analysis.
Topics: Humans; Cardioplegic Solutions; Prospective Studies; Potassium Chloride; Mannitol; Glucose; Heart Arrest, Induced
PubMed: 35244373
DOI: 10.21470/1678-9741-2020-0662 -
Indian Journal of Ophthalmology Apr 2023Dry eye disease (DED) is a common multi-factorial disease that is characterized by tear film instability. Diquafosol tetrasodium (DQS), an ophthalmic solution, has been... (Meta-Analysis)
Meta-Analysis
Dry eye disease (DED) is a common multi-factorial disease that is characterized by tear film instability. Diquafosol tetrasodium (DQS), an ophthalmic solution, has been shown to be beneficial in the treatment of DED. The goal of this study was to provide an update on the safety and efficacy of topical 3% DQS in treating DED patients. A thorough search for all the published randomized controlled trials (RCTs) up to March 31, 2022 in CENTRAL, PubMed, Scopus, and Google Scholar databases was performed. Data were reported as standardized mean difference (SMD) with 95% confidence interval (CI). Modified Jadad scale was used for sensitivity analysis. Funnel plot and Egger's regression test assessed the publication bias. Fourteen RCTs evaluating the safety and efficacy of topical 3% DQS treatment in DED patients were included. Eight included RCTs reported data on the DED after cataract surgery. Overall findings suggest that 3% DQS treatment in DED patients was associated with significantly better improvement at 4 weeks in tear breakup time, Schirmer test, fluorescein staining scores, and Rose Bengal staining score as compared to patients treated with others eye drops including artificial tears or 01% sodium hyaluronate. However, no significant difference in ocular surface disease index was observed. Our findings suggest that 3% DQS treatment is safer and had a superior efficacy compared to artificial tears or sodium hyaluronate for treating DED in general and DED after cataract surgery.
Topics: Humans; Dry Eye Syndromes; Hyaluronic Acid; Lubricant Eye Drops; Ophthalmic Solutions; Randomized Controlled Trials as Topic; Tears; Cataract Extraction; Polyphosphates; Uracil Nucleotides
PubMed: 37026262
DOI: 10.4103/IJO.IJO_268_23 -
International Journal of Molecular... Jun 2023Nanocarriers for oxygen delivery have been the focus of extensive research to ameliorate the therapeutic effects of current anti-cancer treatments and in the organ...
Nanocarriers for oxygen delivery have been the focus of extensive research to ameliorate the therapeutic effects of current anti-cancer treatments and in the organ transplant field. In the latter application, the use of oxygenated cardioplegic solution (CS) during cardiac arrest is certainly beneficial, and fully oxygenated crystalloid solutions may be excellent means of myocardial protection, albeit for a limited time. Therefore, to overcome this drawback, oxygenated nanosponges (NSs) that can store and slowly release oxygen over a controlled period have been chosen as nanocarriers to enhance the functionality of cardioplegic solutions. Different components can be used to prepare nanocarrier formulations for saturated oxygen delivery, and these include native α-cyclodextrin (αCD), αcyclodextrin-based nanosponges (αCD-NSs), native cyclic nigerosyl-nigerose (CNN), and cyclic nigerosyl-nigerose-based nanosponges (CNN-NSs). Oxygen release kinetics varied depending on the nanocarrier used, demonstrating higher oxygen release after 24 h for NSs than the native αCD and CNN. CNN-NSs presented the highest oxygen concentration (8.57 mg/L) in the National Institutes of Health (NIH) CS recorded at 37 °C for 12 h. The NSs retained more oxygen at 1.30 g/L than 0.13 g/L. These nanocarriers have considerable versatility and the ability to store oxygen and prolong the amount of time that the heart remains in hypothermic CS. The physicochemical characterization presents a promising oxygen-carrier formulation that can prolong the release of oxygen at low temperatures. This can make the nanocarriers suitable for the storage of hearts during the explant and transport procedure.
Topics: Humans; Cardioplegic Solutions; Oxygen; Heart; Myocardium; Heart Arrest
PubMed: 37373223
DOI: 10.3390/ijms241210073 -
European Journal of Hospital Pharmacy :... Nov 2022To determine the physicochemical stability of pemetrexed diarginine in original vials, and after dilution in two commonly used infusion fluids (0.9% sodium chloride, 5%...
OBJECTIVES
To determine the physicochemical stability of pemetrexed diarginine in original vials, and after dilution in two commonly used infusion fluids (0.9% sodium chloride, 5% dextrose) in polyolefin bags, stored under refrigeration (2-8°C) or at ambient temperature (22-25°C) exposed to light.
METHODS
Stability of pemetrexed diarginine injection concentrate was determined in the original glass vials with closed-system transfer device. Diluted pemetrexed diarginine infusion solutions were aseptically prepared by dilution of pemetrexed diarginine concentrate with either 0.9% sodium chloride or dextrose 5% in polyolefin bags, in amounts yielding pemetrexed diarginine concentrations of 4, 9 and 12 mg/mL. Test solutions were stored under refrigeration (2-8°C) or at ambient temperature (22-25°C) exposed to light. Pemetrexed diarginine concentrations were determined throughout a 14-day storage period using a stability-indicating HPLC assay. In addition, test solutions were visually examined for colour change and precipitation.
RESULTS
Pemetrexed diarginine injection concentrate with closed-system transfer device is shown to be physicochemically stable for up to 4 days when stored under refrigeration and for 1 day at room temperature. A browning of the pemetrexed diarginine concentrate solutions appeared 0n day 2 when stored at ambient temperature and on day 5 under refrigeration. Pemetrexed diarginine diluted in dextrose 5% and 0.9% sodium chloride was physicochemically stable for up to 4 days when stored under refrigeration and for 1 day at room temperature. A browning of the diluted solutions appeared on day 2 when stored at room temperature and on day 5 when stored under refrigeration.
CONCLUSIONS
Pemetrexed diarginine concentrate for solution stored under refrigeration with closed-system transfer device can be retained as a residual to reduce product losses. The analytical stability of pemetrexed diarginine in dextrose 5% and 0.9% sodium chloride under refrigeration enables our centralised unit to prepare this drug in advance.
Topics: Pemetrexed; Drug Storage; Drug Stability; Sodium Chloride; Drug Packaging; Pharmaceutical Solutions; Glucose
PubMed: 33658227
DOI: 10.1136/ejhpharm-2020-002620 -
Nefrologia : Publicacion Oficial de La... 2007