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1.
Einstein (Sao Paulo) ; 18: eAO5066, 2020.
Artículo en Inglés, Portugués | MEDLINE | ID: mdl-32074222

RESUMEN

OBJECTIVE: To characterize storage and disposal practices associated with expired medicines in home pharmacies of Primary Care users. METHODS: Cross-sectional study based on data collected from 423 users of 15 Primary Care units located in a Brazilian city, between August 2014 and July 2016. Data were collected via face-to-face interviews. Categorical (demographic and socioeconomic characteristics) and continuous variables were expressed as proportions and means and standard deviations, respectively . Storage behaviors and disposal practices associated with unused and expired medicines were described as frequencies. RESULTS: Most (83%) interviewees were female and approximately 70% had completed high school. The kitchen was the most common medicine storage place (58.6%). Approximately 75% of participants reported inappropriate medicine disposal practices. CONCLUSION: This study revealed high rates of inappropriate medicine disposal practices with direct impacts on pharmacological treatment and the environment. Continuing education of healthcare professionals and the general public is required to raise awareness about proper medicine use and disposal.


Asunto(s)
Almacenaje de Medicamentos/estadística & datos numéricos , Familia/psicología , Conocimientos, Actitudes y Práctica en Salud , Eliminación de Residuos Sanitarios/estadística & datos numéricos , Brasil , Estudios Transversales , Escolaridad , Ambiente , Femenino , Humanos , Masculino , Eliminación de Residuos Sanitarios/métodos , Farmacias/estadística & datos numéricos , Encuestas y Cuestionarios
2.
Int J Pharm Compd ; 24(1): 14-19, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32023211

RESUMEN

The U.S. Food and Drug Administration regulates outsourcing facilities with the same stringency they apply towards drug manufacturers. This means that outsourcing facilities, who must navigate the changing regulatory landscape to achieve and maintain 503B status, must now focus on qualifying container closure systems for their intended use. This article, the second in a two-part series, examines component selection and methods for demonstrating that the container closure system will protect and maintain the quality of the compounded drug and ensure that the compounded drug can be safely administered to a patient.


Asunto(s)
Embalaje de Medicamentos , Almacenaje de Medicamentos , Humanos , Estados Unidos , United States Food and Drug Administration
3.
Int J Pharm Compd ; 24(1): 64-68, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32023217

RESUMEN

In order to avoid fluid overload, more concentrated drug solutions in intensive care units are commonly used. This study evaluated the physicochemical stability of concentrated solution of isosorbide dinitrate in polypropylene syringes during 28 days at 5°C ± 3°C with protection from light. Five syringes of 50 mL, containing 0.60 mg/mL of isosorbide dinitrate in sodium chloride 0.9% were prepared and stored at 5°C ± 3°C with protection from light during 28 days. Immediately after preparation and periodically during the storage, isosorbide dinitrate concentration was measured by an ultra-performance liquid chromatography. Spectrophotometric absorbance at different wavelengths, pH measurements, and microscopic observations were also performed. All solutions were physicochemically stable during the whole period storage at 5°C ± 3°C. No color change, turbidity, precipitation or opacity, significant pH variations, or optic densities were observed in the solutions. Any crystals were seen by microscopic analysis. The concentration of isosorbide dinitrate remained above 90% of the initial concentration during the 28 days of storage. Solutions of isosorbide dinitrate 0.60 mg/mL in syringe of sodium chloride 0.9 % injection can be considered physically and chemically stable for 28 days when stored in syringes at 5°C ± 3°C with protection from light and may be prepared in advance by a centralized intravenous additive service.


Asunto(s)
Polipropilenos , Jeringas , Estabilidad de Medicamentos , Almacenaje de Medicamentos , Unidades de Cuidados Intensivos , Dinitrato de Isosorbide
4.
PLoS One ; 15(1): e0227231, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-31923260

RESUMEN

A platform capable of specifically delivering an antiviral drug to the liver infected with hepatitis B is a major concern in hepatology. Vaccination has had a major effect on decreasing the emerging numbers of new cases of infection. However, the total elimination of the hepatitis B virus from the body requires prolonged therapy. In this work, we aimed to target the liver macrophages with lipid polymer hybrid nanoparticles (LPH), combining the merit of polymeric nanoparticles and lipid vesicles. The hydrophilic antiviral drug, entecavir (E), loaded LPH nanoparticles were optimized and physicochemically characterized. A modulated lipidic corona, as well as, an additional coat with vitamin E were used to extend the drug release enhance the macrophage uptake. The selected vitamin E coated LPH nanoparticles enriched with lecithin-glyceryl monostearate lipid shell exhibited high entrapment for E (80.47%), a size ≤ 200 nm for liver passive targeting, extended release over one week, proven serum stability, retained stability after refrigeration storage for 6 months. Upon macrophage uptake in vitro assessment, the presented formulation displayed promising traits, enhancing the cellular retention in J774 macrophages cells. In vivo and antiviral activity futuristic studies would help in the potential application of the ELPH in hepatitis B control.


Asunto(s)
Antivirales/farmacología , Sistemas de Liberación de Medicamentos/métodos , Guanina/análogos & derivados , Hepatitis B/metabolismo , Lípidos/química , Macrófagos/efectos de los fármacos , Nanopartículas/química , Polímeros/química , Vitamina E/química , Animales , Antivirales/administración & dosificación , Antivirales/uso terapéutico , Línea Celular Tumoral , Supervivencia Celular/efectos de los fármacos , Liberación de Fármacos , Estabilidad de Medicamentos , Almacenaje de Medicamentos , Eritrocitos/efectos de los fármacos , Guanina/administración & dosificación , Guanina/farmacología , Guanina/uso terapéutico , Hepatitis B/tratamiento farmacológico , Masculino , Ratones , Ratas
5.
AAPS PharmSciTech ; 21(2): 41, 2020 Jan 02.
Artículo en Inglés | MEDLINE | ID: mdl-31898765

RESUMEN

Coamorphous formulation, a homogeneous monophasic amorphous system composed of multiple components, has been demonstrated as an effective approach for delivering drugs with poor aqueous solubility. In this study, we prepared the coamorphous system composed of two poorly soluble drugs febuxostat (FEB) and indomethacin (IMC) by using cryogenic milling. The combination of these two drugs in the coamorphous form can attain a synergistic effect, especially on gout therapy. Coamorphous solid of FEB and IMC in 1:1 molar ratio exhibited superior physical stability compared with the individual amorphous components, as evidenced by X-ray powder diffractions after 30 days of storage at ambient and elevated temperature. In addition, the FEB-IMC coamorphous system has been demonstrated to show enhanced dissolution performance. The intrinsic dissolution rates of two components in the coamorphous system exhibited the synchronized drug release. Based on the FT-IR spectroscopy, the excellent physical stability and synchronized release of FEB-IMC coamorphous system could be attributed to the heterodimer structure formed by strong hydrogen bonding interactions between these drugs. Furthermore, the supersaturation potential of FEB-IMC coamorphous solids was also investigated through the cosolvent quenching method. The FEB-IMC coamorphous system can effectively inhibit the fast crystallization of FEB in the supersaturated solution. However, the maximum achievable supersaturation of IMC in the coamorphous system decreases to only one fifth of that achieved for the pure amorphous IMC. These results are relevant for understanding the physical stability and complex solution behaviors of the coamorphous formulation.


Asunto(s)
Febuxostat/química , Supresores de la Gota/química , Indometacina/química , Cromatografía Líquida de Alta Presión , Combinación de Medicamentos , Composición de Medicamentos , Estabilidad de Medicamentos , Almacenaje de Medicamentos , Febuxostat/administración & dosificación , Supresores de la Gota/administración & dosificación , Enlace de Hidrógeno , Indometacina/administración & dosificación , Polvos , Solubilidad , Espectroscopía Infrarroja por Transformada de Fourier , Difracción de Rayos X
6.
Eur J Pharm Sci ; 141: 105102, 2020 Jan 01.
Artículo en Inglés | MEDLINE | ID: mdl-31655210

RESUMEN

PURPOSE: To assess the physico-chemical stability of Voriconazole Eye-Drops (VED), when stored frozen and refrigerated once thawed, in 3 containers: Amber glass with a Low-Density PolyEthylene (LDPE) eyedropper, and two types of LDPE bottles: one classical and one with an innovative insert that maintains sterility after opening (Novelia® from Nemera). METHODS: Three batches of 1% VED (10 mL) were aseptically compounded from marketed injectable voriconazole (Vfend®) diluted in sterile water for injection. VEDs were stored for three months at -20 °C in amber glass (n = 32), classical LDPE (n = 32) or innovative LDPE (n = 31) bottles. Stability-indicating (HPLC-UV-DAD) and chiral chromatography methods were developed. The stability study was conducted according to GERPAC-SFPC guidelines. At each study time, the following parameters were controlled: visual aspect, voriconazole concentration, pH and osmolality. In addition, non-visible particle count, sterility and absence of racemisation (impurity D - (2S,3R)-voriconazole) were assessed at the beginning and end of the study. Results are expressed as mean ± standard deviation. Statistical analyses were performed using non-parametric tests (α < 5%) to compare containers. RESULTS: When stored frozen, concentration was between 95.2 ±â€¯1.4% and 103.6 ±â€¯1.3% of the initial concentration (C0) with no difference between the three containers (p = 0.564; non-significant). Fifteen days after thawing, concentration was between 97.1 ±â€¯1.6% and 98.6 ±â€¯0.8% of C0 with no difference between containers (p = 0.278 and 0.368 for VED thawed at room temperature and at 2-8 °C, respectively). pH remained stable between each time. Osmolality was slightly higher in glass (533.17 ±â€¯8.93 mOsm/Kg) than in plastic containers (522.17±3.31mOsm/Kg, classical LDPE; 517.5 ±â€¯12.42 mOsm/Kg, innovative LDPE) (p = 0.022). Sterility was preserved. Degradation product areas increased slightly but remained below the limit of quantification. Impurity D was never detected. CONCLUSION: We have demonstrated that the ability of the innovative container Novelia® to maintain VED physicochemical and microbiological stability does not differ from that of amber glass and classical LDPE containers. Real life studies are required to find out if there is a potential difference between Novelia® and other containers in terms of sterility preservation.


Asunto(s)
Antifúngicos/química , Soluciones Oftálmicas/química , Voriconazol/química , Embalaje de Medicamentos , Estabilidad de Medicamentos , Almacenaje de Medicamentos , Congelación , Vidrio/química , Polietileno/química
7.
J Pharm Biomed Anal ; 177: 112839, 2020 Jan 05.
Artículo en Inglés | MEDLINE | ID: mdl-31505430

RESUMEN

Parenteral amino acid solutions containing tryptophan tend to develop a yellow colouration upon storage. Hence, the aim of the present study was to find out whether tryptophan degradation products are the reason for the yellowing. The degree of discolouration and tryptophan degradation was examined by visual examination and UV/Vis measurements with respect to oxygen presence, pH value, and duration of steam sterilization. LC-UV analyses of autoclaved tryptophan solutions indicated eight degradation products, namely R,R/R,S 2-amino-3-(oxoindolin-3-yl)propanoic acid, R,R/R,S 2-amino-3-hydroxy-2-oxoindolin-3-yl)propanoic acids, cis/trans 3a-hydroxy-1,2,3,3a,8,8a-hexahydropyrrolo[2,3-b]indole-2-carboxylic acid, N´-formylkynurenine, and kynurenine. The proposed degradation products were confirmed by spiking of synthesized degradation products and LC-UV/MS analyses. The LC-UV analysis method was optimized and validated according to the ICH guideline Q2 (R1). Tryptophan stability in commercially available parenteral amino acid formulations was evaluated over a storing period of 12 months in two common types of primary packaging after autoclave procedure.


Asunto(s)
Color , Soluciones para Nutrición Parenteral/química , Control de Calidad , Espectrometría de Masa por Ionización de Electrospray/métodos , Triptófano/química , Cromatografía Líquida de Alta Presión/métodos , Embalaje de Medicamentos/métodos , Embalaje de Medicamentos/normas , Estabilidad de Medicamentos , Almacenaje de Medicamentos/normas , Oxidación-Reducción , Soluciones para Nutrición Parenteral/normas
8.
J Pharm Biomed Anal ; 177: 112881, 2020 Jan 05.
Artículo en Inglés | MEDLINE | ID: mdl-31542419

RESUMEN

The present study was to investigate the degradation profile of sorafenib tosylate (SORA), a potent oral multi-kinase inhibitor under various stress conditions as per ICH (Q1A (R2)) guidelines. Separation of SORA and its degradation products (DP-1-DP-5) was achieved on Acquity UPLC BEH C18 (100 mm × 2.1 mm × 1.7 µm) column using a gradient elution of 0.1% formic acid and acetonitrile at a flow rate of 0.3 mL/min within 12 min. High resolution quadruple time-of-flight mass spectrometer (Q-TOF/MS) was utilized for characterization of all DPs. In ESI/CID-MS/MS experiments, the protonated DP-1 and DP-2 exhibited few interesting product ions which provide a compelling evidence for the compounds to undergo gas phase rearrangement reaction justified by its mechanistic explanation in support with density functional theory (DFT). In-source collision-induced dissociation (IS-CID) fragmentation using ESI/APCI-MS analysis exhibited the formation of N-deoxygenated product ion peak corresponds to pyridine N-oxide moiety as in DP-5. Further, major hydrolytic DPs (DP-2 and DP-3) were isolated on preparative HPLC and structural elucidation was done using ID NMR (1H, 13C and DEPT-135) experiments. In vitro cytotoxicity study for SORA and its isolated DPs were assessed by observing morphological changes in HepG2 cell lines under phase-contrast microscopy and MTT assay. Taken together, it was known that DP-2 and DP-3 were less potent with a cell viability of more than 90% and IC50 >50 µM in comparison with SORA (IC50 = 2.99 ±â€¯0.35 µM). The developed method was validated in terms of specificity, limit of detection, limit of quantification, linearity, accuracy, precision and robustness.


Asunto(s)
Antineoplásicos/química , Química Farmacéutica/métodos , Sorafenib/química , Antineoplásicos/farmacología , Apoptosis/efectos de los fármacos , Supervivencia Celular/efectos de los fármacos , Cromatografía Líquida de Alta Presión/métodos , Estabilidad de Medicamentos , Almacenaje de Medicamentos , Células Hep G2 , Humanos , Hidrólisis , Concentración 50 Inhibidora , Límite de Detección , Espectroscopía de Resonancia Magnética/métodos , Sensibilidad y Especificidad , Sorafenib/farmacología , Espectrometría de Masa por Ionización de Electrospray/métodos , Espectrometría de Masas en Tándem/métodos
9.
J Pharm Biomed Anal ; 177: 112880, 2020 Jan 05.
Artículo en Inglés | MEDLINE | ID: mdl-31546137

RESUMEN

Hepatitis E, which is caused by infection with hepatitis E virus (HEV), is a global health problem in both developed and developing countries. An efficacious hepatitis E vaccine was licensed (by China) in 2011 with a trade name of Hecolin®. The antigen contained in this vaccine is a truncated version of the sole capsid protein encoded by open reading frame 2, which is designated p239. In this study, the real-time and real-condition stability and accelerated stability of five lots of hepatitis E vaccine products at the end of the designated shelf life, were assessed by a well-established quality analysis platform. The protein integrity of p239 that was recovered from the vaccine lots was demonstrated using CE-SDS, LC-MS and MALDI-TOF MS. The particle characteristics of the recovered vaccine antigen were assessed by TEM and HPSEC. The immunogenicity of hepatitis E vaccines was assessed by a mouse potency assay, which is part of product release and stability testing. Several methods were employed to assess the antigenicity of vaccines with or without adjuvant dissolution. Specifically, the well-established methods of sandwich ELISA and surface plasma resonance (SPR)-based BIAcore were used with unique murine monoclonal antibodies. Most interesting, two 'dissolution-free' immunoassays were also used for in situ antigenicity assessment of the vaccines. In addition to the confirmation of vaccine stability at the end of expiry dating, i.e., after storage in recommended conditions (2-8 °C) for 36 months, the mouse potency assay and sandwich ELISA were used to assess the accelerated stability of prefilled syringes to demonstrate the feasibility of out-of-cold-chain storage. In summary, molecular and functional characterization confirmed the shelf life stability of the vaccine at the end of expiry dating and the feasibility of transporting the hepatitis E vaccine for a given period of time out of cold chains.


Asunto(s)
Anticuerpos Antihepatitis/sangre , Virus de la Hepatitis E/inmunología , Hepatitis E/prevención & control , Vacunas Sintéticas/inmunología , Vacunas contra Hepatitis Viral/inmunología , Animales , Estabilidad de Medicamentos , Almacenaje de Medicamentos , Estudios de Factibilidad , Femenino , Anticuerpos Antihepatitis/inmunología , Antígenos de la Hepatitis/inmunología , Hepatitis E/virología , Humanos , Inmunoensayo/métodos , Inmunogenicidad Vacunal , Ratones , Modelos Animales , Temperatura , Factores de Tiempo , Vacunas Sintéticas/administración & dosificación , Vacunas Sintéticas/química , Vacunas contra Hepatitis Viral/administración & dosificación , Vacunas contra Hepatitis Viral/química
10.
Pharm Res ; 37(1): 11, 2019 Dec 23.
Artículo en Inglés | MEDLINE | ID: mdl-31873825

RESUMEN

PURPOSE: Loss of vaccine potency due to extreme temperature exposure during storage and transport remains a significant obstacle to the success of many vaccines, including the Bacille Calmette-Guérin (BCG) vaccine, the only vaccine available against Mycobacterium tuberculosis. BCG is a live, attenuated vaccine requiring refrigerated storage for viability. In this study, we formulated a temperature-stable BCG dry powder using the spray drying technique. METHODS: We employed a factorial design to optimize our formulation of stabilizing excipients that included L-leucine, bovine serum albumin, polyvinylpyrrolidone, mannitol, and trehalose. Powders were characterized for their particle size, yield, water retention and uptake, glass transition temperature, and aerosol performance. Three optimal powder carrier mixtures were selected from the factorial design for BCG incorporation based on their stability-promoting and powder flow characteristics. Vaccine powders were also assessed for BCG viability and in vivo immunogenicity after long-term storage. RESULTS: Live BCG was successfully spray-dried using the optimized carriers. Dry powder BCG showed no loss in viability (25°C, up to 60% relative humidity; RH) and ~2-log loss in viability (40°C, 75% RH) after one year of storage. The aerodynamic size of the powders was in the respirable range. Further, when healthy mice were immunized intradermally with reconstituted BCG powders (storage for 2 years), the vaccine retained its immunogenicity. CONCLUSION: We developed a spray-dried BCG vaccine that was viable and antigenic after long-term storage. To our knowledge, this is a first study to show room temperature stability of live BCG vaccine without any loss in viability for 12 months.


Asunto(s)
Vacuna BCG/química , Vacuna BCG/farmacología , Composición de Medicamentos/métodos , Excipientes/química , Polvos/química , Aerosoles/química , Animales , Línea Celular , Supervivencia Celular , Desecación/métodos , Estabilidad de Medicamentos , Almacenaje de Medicamentos , Femenino , Humanos , Leucina/química , Manitol/química , Ratones Endogámicos C57BL , Mycobacterium bovis/citología , Povidona/química , Albúmina Sérica Bovina/química , Temperatura , Distribución Tisular , Trehalosa/química
11.
J Opioid Manag ; 15(5): 353-354, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31849024
12.
Int J Pharm Compd ; 23(6): 454-461, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31751941

RESUMEN

The U.S. Food and Drug Administration regulates outsourcing facilities with the same stringency they apply towards drug manufacturers. This means that outsourcing facilities, who must navigate the changing regulatory landscape to achieve and maintain 503B status, need to focus on qualifying container closure systems for their intended use. Container closure systems must be fit-for-purpose (i.e., suitable for in-use conditions relative to drug product stability over intended shelf-life and storage conditions). This article, the first of a two-part series, addresses the critical aspect of how to qualify systems for intended use regarding container closure integrity. The second part will address component selection.


Asunto(s)
Embalaje de Medicamentos , Estabilidad de Medicamentos , Almacenaje de Medicamentos , Estados Unidos , United States Food and Drug Administration
13.
Int J Pharm Compd ; 23(6): 519-527, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31751949

RESUMEN

Amlodipine besylate is an antihypertensive agent recommended for the management of hypertension in children and adolescents. The commercially available 2.5-mg, 5-mg, and 10-mg amlodipine besylate tablets do not provide the necessary flexibility in dosing needed for treating children. This flexibility is readily achieved using an oral, liquid dosage form. However, no commercial liquid dosage form of amlodipine currently exists. An extemporaneously compounded suspension from pure drug powder or commercial tablets would provide a convenient option to meet unique patient needs. The purpose of this study was to determine the physicochemical stability of extemporaneously compounded amlodipine besylate suspensions in the PCCA Base, SuspendIt. This base is a sugar-free, paraben-free, dye-free, and gluten-free thixotropic vehicle containing a natural sweetener obtained from the monk fruit. The study design included two amlodipine besylate concentrations to provide stability documentation over a bracketed concentration range for eventual use by compounding pharmacists. A robust stabilityindicating high-performance liquid chromatographic assay for the determination of the chemical stability of amlodipine besylate in SuspendIt was developed and validated. Suspensions of amlodipine were prepared in SuspendIt at 0.5-mg/mL and 10.0-mg/mL concentrations, selected to represent a range within which the drug is commonly dosed. Samples were stored in plastic amber prescription bottles at two temperature conditions (5°C and 25°C). Samples were assayed initially, and at the following time points: 7 days, 14 days, 29 days, 46 days, 60 days, 90 days, 120 days, and 180 days. Physical data such as pH, viscosity, and appearance were also noted. All measurements were obtained in triplicate. A stable extemporaneous product is defined as one that retains at least 90% of the initial drug concentration throughout the sampling period. This study demonstrates that amlodipine besylate is physically and chemically stable in SuspendIt for 90 days in the refrigerator and 7 days at room temperature, retaining 90% of the label claim (initial drug concentration) at both concentrations. The pH values did not change significantly. The viscosity of the refrigerated samples at both concentrations decreased slightly, while that of the room temperature samples showed a marked increase in viscosity. This study provides a viable, compounded alternative for amlodipine in a liquid dosage form, with an adequate beyond-use-date to meet patient needs. The study further provides stability documentation over a bracketed amlodipine concentration range of 0.5 mg/mL to 10.0 mg/mL, allowing compounding pharmacists more flexibility in customizing their formulations.


Asunto(s)
Amlodipino , Antihipertensivos , Cromonas , Composición de Medicamentos , Administración Oral , Adolescente , Amlodipino/química , Antihipertensivos/química , Niño , Cromatografía Líquida de Alta Presión , Estabilidad de Medicamentos , Almacenaje de Medicamentos , Humanos , Suspensiones
14.
BMC Public Health ; 19(1): 1433, 2019 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-31675948

RESUMEN

BACKGROUND: Maintaining quality of vaccines is one of the main challenges of immunization programs in Ethiopia. The objective of this study is to assess the factor affecting vaccine cold chain management practice in immunization health institutions in East Gojam zone of Amhara region, Ethiopia. METHOD: An institutional based cross-sectional study was conducted from March to April 2017 in ten districts of East Gojam zone of Amhara Region. Descriptive statistics and Logistic regression analysis were carried out to identify factors related to the practice of cold chain management. RESULT: Among 60 health institutions, only 46(76.7%) had functional refrigerators. Twenty-one (35%) had a functional generator for backup service and 28(46.6%) had a car/motorbike for transportation of vaccines in case of refrigerator/power failure. Twenty-nine (48.3%) had known the correct vaccine storage temperature (2 °C - 8 °C) in the refrigerator and the results of this study revealed that only 23(38.3%) of respondents had sufficient knowledge about vaccine cold chain management. The finding of this study also revealed that 35(58.3%) had appropriate vaccine cold chain management practice and the rest 25(41.7%) had inappropriate practice. Logistic regression showed us the knowledge gap and profession were significantly associated with vaccine cold chain management practice at P < 0.05. CONCLUSION: This study indicates that there was a knowledge gap of health workers who are working on cold chain management. There is an urgent need to improve knowledge and practice on cold chain management through improved supervision and training at a different level of health care system.


Asunto(s)
Almacenaje de Medicamentos/métodos , Refrigeración/normas , Vacunas , Estudios Transversales , Etiopía , Femenino , Conocimientos, Actitudes y Práctica en Salud , Personal de Salud/psicología , Personal de Salud/estadística & datos numéricos , Humanos , Masculino , Salud Pública
15.
Adv Exp Med Biol ; 1174: 265-290, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31713202

RESUMEN

Amyloids are highly organized cross ß-sheet protein nanofibrils that are associated with both diseases and functions. Thermodynamically amyloids are stable structures as they represent the lowest free energy state that proteins can attain. However, recent studies suggest that amyloid fibrils can be dissociated by a change in environmental parameters such as pH and ionic strength. This reversibility of amyloids can not only be associated with disease, but function as well. In disease-associated amyloids, fibrils can act as reservoirs of cytotoxic oligomers. Recently, in higher organisms such as mammals, hormones were found to be stored in amyloid-like state, where these were reported to act as a reservoir of functional monomers. These hormone amyloids can dissociate to monomers upon release from the secretory granules, and subsequently bind to their respective receptors and perform their functions. In this book chapter, we describe in detail how these protein nanofibrils represent the densest possible peptide packing and are suitable for long-term storage. Thus, mimicking the feature of amyloids to release functional monomers, it is possible to formulate amyloid-based peptide/protein drugs, which can be used for sustained release.


Asunto(s)
Péptidos , Amiloide/química , Animales , Almacenaje de Medicamentos , Nanofibras/química , Hormonas Peptídicas/química , Péptidos/química , Vesículas Secretoras/metabolismo
16.
Afr Health Sci ; 19(2): 1993-1999, 2019 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-31656482

RESUMEN

Background: Rotavirus infection and its associated hospitalization of children less than 5 years old in middle- and low-income countries remains a public health challenge. We hypothesized that the Rotarix®potency is affected by non-optimal temperatures which translates into reduced vaccine effectiveness in these settings. Objective: To assess the effect of non-optimal temperatures on the potency of the Rotarix® vaccine in South Africa. Methods: Rotarix® vaccine was exposed to temperatures reflecting breaches in the cold chain. Vero cells (ATCC CCL-81) grown in a 24-well tissue culture plates were infected with Rotarix® vaccine viruses after exposure to non-optimal temperatures and the potency of the vaccine was determined using the plaque assay. Results: Exposure of the Rotarix® vaccine to seasonal temperatures in KwaZulu-Natal for 6 hours and to extreme temperatures of 40oC for 72 hours as well as to -20°C and -80°C for 12 hours did not affect the potency of the vaccine beyond its expected standard of >7 x 105 PFU/ml. Conclusion: This study revealed that the Rotarix® vaccine remains potent even after exposure to non-optimal temperatures. However, this study only explored the effect of a constant 'adverse' temperature on vaccine potency and not the effect of temperature fluctuations.


Asunto(s)
Estabilidad de Medicamentos , Calor , Vacunas contra Rotavirus/química , Potencia de la Vacuna , Almacenaje de Medicamentos , Humanos , Refrigeración , Infecciones por Rotavirus/prevención & control , Sudáfrica
18.
Int J Pharm Compd ; 23(5): 414-417, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31513540

RESUMEN

Furosemide parenteral solutions are routinely used in our hospital. However, the stability in transparent syringes is unknown. In this study, transparent polypropylene syringes were filled with 8 mL and 50 mL of furosemide 5-mg/mL solution. The furosemide was analyzed by high-performance liquid chromatography and assays were performed up to 35 days of storage of the syringes at 4°C protected from light, plus 24 hours at 20°C exposed to daylight. In addition, the appearance and pH of the solutions were determined. A microbiological assay using tryptic soy broth was also performed. Both types of syringes remained colorless, clear, and free from visible particles throughout the study period. The pH did not change, and concentrations remained between 95% and 105% of the stated concentration. None of the syringes filled with culture media exhibited bacterial or fungal growth. In conclusion, ready-to-administer furosemide 5-mg/mL, 8-mL, and 50-mL polypropylene syringes are stable for up to 35 days when stored in a refrigerator at 4°C protected from light, plus 24 hours at 20°C unprotected from light. These results allow maximum storage time in stock and the ability of 24-hour continuous infusion at ambient room temperature without protecting the syringe against light.


Asunto(s)
Furosemida/química , Polipropilenos , Jeringas , Cromatografía Líquida de Alta Presión , Estabilidad de Medicamentos , Almacenaje de Medicamentos , Polipropilenos/química
19.
Washington, D.C.; OPAS; 2019-09-20. (OPAS/CDE/19-002).
en Portugués | PAHO-IRIS | ID: phr-51562

RESUMEN

Seguindo a recomendação da OMS, de setembro de 2015, de que a “profilaxia pré-exposição (PrEP) oral deve ser oferecida como uma escolha adicional de prevenção para pessoas com risco substancial de contrair o HIV como parte das abordagens de prevenção combinada do HIV”, parceiros de diversos países indicaram a necessidade de terem orientações práticas sobre como considerar introduzir a PrEP e iniciar a implementação da profilaxia. Atendendo a este pedido, a OMS organizou esta série de módulos informativos para auxiliar a implementação da PrEP para diferentes segmentos populacionais em contextos diversos… Módulo 6: Farmacêuticos. Este módulo destina-se a farmacêuticos e pessoas que trabalham em farmácias. Contém informações sobre os medicamentos usados na PrEP, incluindo as condições de armazenamento. Sugere como se pode monitorar a adesão à PrEP e apoiar o uso dos medicamentos com regularidade.


Asunto(s)
VIH , Farmacéuticos , Almacenaje de Medicamentos , Infecciones por VIH , Profilaxis Pre-Exposición
20.
Am J Health Syst Pharm ; 76(1): 50-56, 2019 Jan 01.
Artículo en Inglés | MEDLINE | ID: mdl-31381099

RESUMEN

PURPOSE: Results of a study to evaluate medication storage, distribution, and safety outcomes after addition of 23.4% sodium chloride to a hospital formulary and development of a novel distribution process incorporating safeguards allowing for urgent medication removal from an automated dispensing cabinet (ADC) are reported. SUMMARY: A retrospective review of 23.4% sodium chloride injection doses dispensed during a 38-month period was performed at an academic medical center to evaluate times from order entry to pharmacist verification, dispensing, and administration; adverse events related to dispensing or administration; and other outcomes. Seventy doses of 23.4% sodium chloride injection were administered to 60 patients during the study period. The mean times from order entry to pharmacist verification, medication removal from an ADC, and administration were 8, 25, and 43 minutes, respectively, when the ADC override function was not used. After 23.4% sodium chloride injection's addition to the ADC override list, 16 of 30 doses were removed "on override," with order entry performed retrospectively for 9 of these doses. There were no documented adverse events related to medication distribution and 2 adverse effects possibly related to medication administration. CONCLUSION: Novel storage and distribution processes for 23.4% sodium chloride injection were implemented at a large academic medical center to optimize safety related to the medication-use process. A retrospective review of 70 administered doses found the process of maintaining this medication in ADCs to be a safe and efficient method of storing and dispensing a high-alert medication.


Asunto(s)
Utilización de Medicamentos/estadística & datos numéricos , Tratamiento de Urgencia/métodos , Errores de Medicación/prevención & control , Sistemas de Medicación en Hospital/organización & administración , Solución Salina Hipertónica/administración & dosificación , Centros Médicos Académicos/organización & administración , Centros Médicos Académicos/estadística & datos numéricos , Adulto , Almacenaje de Medicamentos/estadística & datos numéricos , Tratamiento de Urgencia/efectos adversos , Femenino , Humanos , Inyecciones Intravenosas/efectos adversos , Masculino , Sistemas de Entrada de Órdenes Médicas/organización & administración , Sistemas de Entrada de Órdenes Médicas/estadística & datos numéricos , Sistemas de Medicación en Hospital/estadística & datos numéricos , Persona de Mediana Edad , Servicio de Farmacia en Hospital/normas , Servicio de Farmacia en Hospital/estadística & datos numéricos , Estudios Retrospectivos , Solución Salina Hipertónica/efectos adversos
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