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2.
AAPS PharmSciTech ; 21(2): 70, 2020 Jan 17.
Artículo en Inglés | MEDLINE | ID: mdl-31953771

RESUMEN

Synthetic peptides used as therapeutic medicines is continuing to grow as an area of focus within the pharmaceutical industry due to specificity and potency. As such, quality control areas need to continue to advance their capabilities to ensure that appropriate analyses are being performed, and that the data generated are both accurate and precise. One area which poses a significant challenge compared with traditional small molecule drug products is having a highly robust, low variability method of quantifying the assay of the active substance. As many peptide therapeutics are formulated as liquid drug products for injection and preparation procedures to make these samples amenable to traditional chromatographic analysis are inherently low variability (i.e., a simple dilution), potential sources of variance derived from the preparation of the analytical standards used to quantify the assay of the product must be investigated. Here, a fully nested ANOVA experimental design was utilized to examine this process. Such a design allowed for multiple variables to be interrogated as well as the potential interplay of such differences. It was determined that sonication of the standards contributed the most variance, while the balance used and scale on which the standard preparation procedure was performed also contributed significantly. Finally, different procedures for introducing the material into a coulometric Karl Fischer (KF) titration device to quantify the water content of the drug substance were compared and showed that indirect quantification by anhydrous methanol extraction is a significantly more variable method than using an Oven KF autosampler.


Asunto(s)
Cromatografía Líquida de Alta Presión/normas , Liofilización , Péptidos/análisis , Preparaciones Farmacéuticas/análisis , Estándares de Referencia , Análisis de Varianza , Cromatografía Líquida de Alta Presión/métodos , Composición de Medicamentos/normas , Control de Calidad , Reproducibilidad de los Resultados , Sonicación , Agua/análisis
3.
J Pharm Biomed Anal ; 177: 112851, 2020 Jan 05.
Artículo en Inglés | MEDLINE | ID: mdl-31499427

RESUMEN

A high performance liquid chromatographic method was developed for the simultaneous determination of the related substances (R-ivabradine, dehydro-S-ivabradine, N-demethyl-S-ivabradine, ((S)-3,4-dimethoxy-bicyclo[4.2.0]octa-1,3,5-triene-7-yl-methyl)-methyl-amine) and 1-(7,8-dimethoxy-1,3,4,5-tetrahydro-2H-3-benzazepine-2-on-3-yl)-3-chloro-propane) of the heart-rate lowering drug, ivabradine. The separation capability of seven different polysaccharide-type chiral columns (Lux Amylose-1, Lux i-Amylose-1, Lux Amylose-2, Lux Cellulose-1, Lux Cellulose-2, Lux Cellulose-3 and Lux Cellulose-4) was investigated with a mobile phase consisting of 0.1% diethylamine in methanol, 2-propanol and acetonitrile. During the screnning experiments the best results were obtained on Lux Cellulose-2 (based on cellulose tris(3-chloro-4-methylphenylcarbamate) column with methanol with an ideal case, where all the impurities eluted before the S-ivabradine peak. Chromatographic parameters (flow rate, temperature and mobile phase constituents) were optimized by a full factorial screening design. Using optimized parameters (Lux Cellulose-2 column with 0.06% (v/v) diethylamine in methanol/acetonitrile 98/2 (v/v) with 0.45 mL/min flow rate at 12 °C) baseline separations were achieved between all compounds. The optimized method was validated according to the International Council on Harmonization Q2(R1) guideline and proved to be reliable, linear, precise and accurate for determination of at least 0.05% for all impurities in S-ivabradine samples. Method application was tested on a commercial tablet formulation and proved to be suitable for routine quality control of both chiral and achiral related substances of S-ivabradine.


Asunto(s)
Composición de Medicamentos/normas , Contaminación de Medicamentos/prevención & control , Ivabradina/análisis , Control de Calidad , Celulosa/análogos & derivados , Celulosa/química , Química Farmacéutica , Cromatografía Líquida de Alta Presión/instrumentación , Ivabradina/química , Fenilcarbamatos/química , Estereoisomerismo , Comprimidos , Temperatura
4.
J Pharm Biomed Anal ; 177: 112846, 2020 Jan 05.
Artículo en Inglés | MEDLINE | ID: mdl-31522097

RESUMEN

The ß-lactam core is a key structure responsible for inducing both IgE-mediated acute-onset hypersensitivity and T-cell-mediated delayed-onset hypersensitivity with penicillins in humans. There is essentially no clinically significant immunologic cross-reactivity noted between the ß-lactam cores of penicillins and cephalosporins based on challenge studies in humans. The side-chains appear to be more important in inducing IgE-mediated acute-onset hypersensitivity and T-cell delayed-onset hypersensitivity with cephalosporins in humans. Despite these clinical findings, the U. S. Food and Drug Administration (FDA) still requires the level of ß-lactam-related antibiotic residues to be controlled at very low levels in manufacturing facilities. Ceftolozane is Merck & Co., Inc., Kenilworth, NJ, USA's (MSD's) 5th generation broad spectrum cephalosporin antibiotic against gram-negative bacteria. In searching for the optimal decontamination method of ceftolozane, most methods were found to be very slow in opening the ß-lactam ring in ceftolozane. Moreover, most of the previously reported decontamination methods applied analytical methods that only monitored the disappearance of the parent molecule as the endpoint of degradation. In this way, many of the ß-lactam-containing degradation products could be overlooked. In order to develop an efficient decontamination solution for ceftolozane, a sensitive ultra high performance liquid chromatography-high resolution-electrospray ionization-tandem mass spectrometry (UHPLC-HRMS/MS) method was first developed to ensure the detection of the ß-lactam ring in all degradation products. Through online UHPLC-UV-HRMS monitoring, 2.5 N KOH in 50% aqueous MeOH or 50% aqueous EtOH was identified as the best condition to fully degrade the ß-lactam ring in ceftolozane. This decontamination could be done within 15 min, even at 100 mg/mL concentration, and thus enable a quick turnaround time for equipment cleaning in the ß-lactam manufacturing facility. This method was also successfully applied to 12 other commercially available ß-lactam antibiotics.


Asunto(s)
Antibacterianos/análisis , Cefalosporinas/análisis , Descontaminación/métodos , Composición de Medicamentos/instrumentación , Contaminación de Equipos/prevención & control , Antibacterianos/química , Antibacterianos/toxicidad , Cefalosporinas/química , Cefalosporinas/toxicidad , Cromatografía Líquida de Alta Presión/métodos , Composición de Medicamentos/métodos , Composición de Medicamentos/normas , Etanol/química , Hidróxidos/química , Metanol/química , Compuestos de Potasio/química , Solventes/química , Espectrometría de Masa por Ionización de Electrospray/métodos , Espectrometría de Masas en Tándem/métodos
5.
J Pharm Biomed Anal ; 177: 112868, 2020 Jan 05.
Artículo en Inglés | MEDLINE | ID: mdl-31539713

RESUMEN

Traditional Chinese Medicine Injection (TCMI) was restricted due to the batch-to-batch variability caused by the variable compositions of botanical raw materials and complexities of the current manufacturing process. To evaluate and control the quality of Kudiezi Injection (KDZI), a comprehensive and practical method based on multidimensional chromatographic fingerprint associated with multivariate statistical analysis was proposed. The multidimensional chromatographic fingerprint was established by integrating three kinds of chromatographic fingerprints, including High Performance Liquid Chromatography-Ultraviolet spectrum (HPLC-UV), Gas Chromatography-Mass Spectrometer (GC-MS) and High performance ion-exchange chromatography (HPIEC), which were used to detect flavones, nucleosides, organic acids, amino acids and saccharides in KDZI. In addition, four main multivariate statistical analyses were compared to assess the batch-to-batch consistency of samples. Results showed that the cosine method, which has been widely used in the quality evaluation of TCM, failed to distinguish the differences among batches based on neither chromatographic peaks' area nor contents information. t-test and Bayes' theorem could reveal the content difference among batches, while hierarchical clustering analysis could differentiate KDZI batches, and Luteolin-7-O-ß-D-glucuronopyranoside, Tau, Ser, guanine and allose were the main indicators. In conclusion, multidimensional chromatographic fingerprints could reflect the quality information of KDZI comprehensively and hierarchical clustering analysis was suitable to identify the differences among batches. This could provide an integrated method for consistency evaluation of TCMI, process improvement of TCMI and solving similar problems in TCMI.


Asunto(s)
Composición de Medicamentos/normas , Medicamentos Herbarios Chinos/análisis , Control de Calidad , Cromatografía Líquida de Alta Presión/métodos , Medicamentos Herbarios Chinos/química , Cromatografía de Gases y Espectrometría de Masas/métodos , Medicina Tradicional Mongoliana/métodos
6.
BMC Pharmacol Toxicol ; 20(Suppl 1): 82, 2019 12 19.
Artículo en Inglés | MEDLINE | ID: mdl-31852534

RESUMEN

BACKGROUND: The presence of impurities in some drugs may compromise the safety and efficacy of the patient's treatment. Therefore, establishing of the biological safety of the impurities is essential. Diabetic patients are predisposed to tissue damage due to an increased oxidative stress process; and drug impurities may contribute to these toxic effects. In this context, the aim of this work was to study the toxicity, in 3 T3 cells, of the antidiabetic agents sitagliptin, vildagliptin, and their two main impurities of synthesis (S1 and S2; V1 and V2, respectively). METHODS: MTT reduction and neutral red uptake assays were performed in cytotoxicity tests. In addition, DNA damage (measured by comet assay), intracellular free radicals (by DCF), NO production, and mitochondrial membrane potential (ΔψM) were evaluated. RESULTS: Cytotoxicity was observed for impurity V2. Free radicals generation was found at 1000 µM of sitagliptin and 10 µM of both vildagliptin impurities (V1 and V2). A decrease in NO production was observed for all vildagliptin concentrations. No alterations were observed in ΔψM or DNA damage at the tested concentrations. CONCLUSIONS: This study demonstrated that the presence of impurities might increase the cytotoxicity and oxidative stress of the pharmaceutical formulations at the concentrations studied.


Asunto(s)
Composición de Medicamentos/normas , Contaminación de Medicamentos , Fibroblastos/efectos de los fármacos , Hipoglucemiantes/toxicidad , Fosfato de Sitagliptina/toxicidad , Vildagliptina/toxicidad , Células 3T3 , Animales , Supervivencia Celular/efectos de los fármacos , Daño del ADN , Fibroblastos/metabolismo , Fibroblastos/patología , Hipoglucemiantes/química , Potencial de la Membrana Mitocondrial/efectos de los fármacos , Ratones , Óxido Nítrico/metabolismo , Especies Reactivas de Oxígeno/metabolismo , Fosfato de Sitagliptina/química , Vildagliptina/química
7.
AAPS PharmSciTech ; 21(1): 1, 2019 Nov 11.
Artículo en Inglés | MEDLINE | ID: mdl-31712905

RESUMEN

The SeDeM diagram expert system has been applied to study Zidovudine and some excipients. From the obtained diagrams, a pharmaceutical formula has been designed. SeDeM diagram ascertains the critical parameters that are suitable for a direct compression. The formula is compressed using a rotary tablet press simulator which emulates rotary tablet press' compression profiles. From these compressions, we study the formula behavior under different industrial production conditions but saving a huge amount of material. The study is done at different compression forces and compression speeds and taking into account the influence of the pre-compression force. The differences observed between the compression profiles are hereby described. The results indicate that the formulation is able to be compressed adequately with the emulated compression profiles and no differences are observed between the final products. Therefore, we can assure that the SeDeM diagram expert system is accurate and robust. Moreover, its results are comparable with the compression results in a rotary tablet press, which has never been described in the pharmaceutical literature before. From the obtained results, it is possible to select the best rotary press to scale-up this formulation.


Asunto(s)
Fármacos Anti-VIH/administración & dosificación , Composición de Medicamentos/instrumentación , Composición de Medicamentos/métodos , Sistemas Especialistas , Comprimidos , Zidovudina/administración & dosificación , Composición de Medicamentos/normas , Industria Farmacéutica , Excipientes , Pruebas de Dureza , Polvos
9.
Am J Health Syst Pharm ; 76(19): 1481-1491, 2019 Sep 16.
Artículo en Inglés | MEDLINE | ID: mdl-31532506

RESUMEN

PURPOSE: Risks and vulnerabilities of the medication-use process in nonpediatric institutions that also serve pediatric patients are reviewed, and guidance on risk mitigation strategies is provided. SUMMARY: There are many risks and vulnerabilities in the medication-use process as it relates to pharmacotherapy for pediatric patients admitted to adult institutions. Mitigation of these risks is critical and should encompass various available resources and strategies. Special emphasis should be placed on use of technology to improve overall safety. Available literature recommends optimization of technology and resource use, institutional support for pediatric pharmacists' involvement in managing pediatric medication use, and provision of early exposure to pediatric patients in pharmacist training programs as additional methods of mitigating risks associated with pediatric medication use in adult institutions. Adult hospitals that provide care for pediatric patients should assess their processes in order to identify hospital-specific interventions to promote pediatric medication safety. CONCLUSION: Pediatric medication safety frameworks in U.S. adult institutions vary widely. Treating pediatric patients involves risks in all areas of the medication-use process. Optimizing technology, utilizing external resources, supporting a pediatric pharmacist, and providing early-career exposure to pediatric patients are methods to mitigate risks in institutions that primarily serve adult patients.


Asunto(s)
Errores de Medicación/prevención & control , Administración del Tratamiento Farmacológico/organización & administración , Farmacéuticos/organización & administración , Servicio de Farmacia en Hospital/organización & administración , Administración de la Seguridad/normas , Adulto , Factores de Edad , Niño , Sistemas de Información en Farmacia Clínica/organización & administración , Sistemas de Información en Farmacia Clínica/normas , Composición de Medicamentos/normas , Cálculo de Dosificación de Drogas , Educación en Farmacia , Educación Continua en Farmacia , Humanos , Sistemas de Entrada de Órdenes Médicas/organización & administración , Sistemas de Entrada de Órdenes Médicas/normas , Administración del Tratamiento Farmacológico/normas , Farmacéuticos/normas , Servicio de Farmacia en Hospital/normas , Guías de Práctica Clínica como Asunto , Rol Profesional
10.
Am J Health Syst Pharm ; 76(19): 1492-1510, 2019 Sep 16.
Artículo en Inglés | MEDLINE | ID: mdl-31532507

RESUMEN

PURPOSE: Current clinical practice guidelines on management of enteral nutrition (EN) and parenteral nutrition (PN) in pediatric patients are reviewed. SUMMARY: The provision of EN and PN in pediatric patients poses many unique considerations and challenges. Although indications for use of EN and PN are similar in adult and pediatric populations, recommended EN and PN practices differ for pediatric versus adult patients in areas such as selection of EN and PN formulations, timing of EN and PN initiation, advancement of nutrition support, and EN and PN goals. Additionally, provision of EN and PN to pediatric patients poses unique compounding and medication administration challenges. This article provides a review of current EN and PN best practices and special nutrition considerations for neonates, infants, and other pediatric patients. CONCLUSION: The provision of EN and PN to pediatric patients presents many unique challenges. It is important for pharmacists to keep current with pediatric- and neonatal-specific guidelines on nutritional management of various disease states, as well as strategies to address compounding and medication administration challenges, in order to optimize EN and PN outcomes.


Asunto(s)
Desarrollo Infantil/fisiología , Nutrición Enteral/normas , Necesidades Nutricionales/fisiología , Nutrición Parenteral/normas , Servicio de Farmacia en Hospital/organización & administración , Adulto , Factores de Edad , Niño , Preescolar , Composición de Medicamentos/normas , Humanos , Lactante , Recién Nacido , Recien Nacido Prematuro/fisiología , Farmacéuticos/organización & administración , Servicio de Farmacia en Hospital/normas , Guías de Práctica Clínica como Asunto
11.
Int J Pharm Compd ; 23(5): 399-402, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31513539

RESUMEN

Water is the most abundant substance on earth, covering about 70% of the earth's surface. Life is dependent upon water and the water cycles involved. In pharmaceutical compounding, water is the most widely used excipient employed as a solubilizing agent and as a vehicle; it is also used medicinally. With the variety in dosage forms, there are different types of waters that are used, some with specific uses and some more general. For the different types or categories of water, there are different methods of preparation, different characteristics, and different properties that can be used as an advantage in compounding. This article describes the different categories of waters, their use, preparation, characteristics, and water chemistry in general.


Asunto(s)
Excipientes , Agua , Composición de Medicamentos/normas
12.
Int J Pharm Compd ; 23(5): 428-433, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31513543

RESUMEN

Compounding for veterinarians is regulated by the U.S. Food and Drug Administration, but day-to-day regulation is deferred to the state authorities. Veterinarians must meet certain standards when prescribing or dispensing a compounded medication. Veterinarians are expected to maintain current knowledge of the benefit of compounded preparations and prescribe and dispense in keeping with the best evidence related to animal and human health. Whether veterinarians recognize or adhere to these standards is unknown. A self-administered survey was distributed electronically to 30,000 email addresses on record with the Veterinary International Network. The survey asked questions about the regulations and standards associated with the use of or prescription of compounded medications. Of the distributed surveys, 1,520 survey responses were received, for a 5.1% response rate. All surveys were included in the final analysis. Respondents with a higher training level in compounding had a greater perceived skill level regarding compounding of medications (r = 0.26, P<0.0001). Similarly, respondents with a higher training level had a greater knowledge of state laws and regulations (r = 0.14, P<0.0001). Those with formal training had better scores on the assessment questions than those with informal or no training (P=0.01). Approximately one-third of the respondents felt that they were not knowledgeable at all about compounding rules and regulations. The most common compounded medications used in practice by veterinarians are methimazole, metronidazole, and doxycycline. Veterinarians mostly recognized that compounding backordered, commercially available products is permitted. Formal training improves familiarity with compounding rules, regulations, and current practices. Therefore, efforts should be directed at improving veterinary knowledge of laws and regulations surrounding the practice of compounding medications.


Asunto(s)
Metronidazol/farmacología , Veterinarios , Animales , Composición de Medicamentos/normas , Humanos , Metronidazol/química , Estados Unidos , United States Food and Drug Administration/normas
13.
Glob Heart ; 14(3): 327-333, 2019 09.
Artículo en Inglés | MEDLINE | ID: mdl-31451241

RESUMEN

BACKGROUND: Widespread access to good quality antihypertensive medicines is a critical component for reducing premature cardiovascular disease (CVD) mortality. Poor-quality medicines pose serious health concerns; however, there remains a knowledge gap about the quality of cardiovascular medicines available in low- and middle-income countries. OBJECTIVES: The aim of this study was to determine the quality of generic antihypertensive medicines available in the retail market of a developing country. METHODS: Samples of the 2 most commonly prescribed classes of antihypertensive medicines were collected from 3 states in 3 different geopolitical zones in Nigeria following a semirandom sampling framework. Medicine samples were purchased by mystery shoppers from 22 pharmacy outlets from 6 local government areas across the 3 states. Medicine quality was determined by measuring the amount of stated active pharmaceutical ingredient using high-performance liquid chromatography with photodiode array detection and classified according to their compliance to the specified pharmacopeia tolerance limits for each antihypertensive drug. RESULTS: Amlodipine and lisinopril were identified as the most commonly prescribed antihypertensive drugs in Nigeria. In total, 361 samples from 22 pharmacies were collected and tested. In total, 24.6% of amlodipine and 31.9% of lisinopril samples were of substandard quality and significantly more samples purchased in rural (59 of 161, 36.7%) compared with urban (32 of 200, 16%) outlets were found to be of substandard quality (p < 0.001). No falsified samples of either amlodipine or lisinopril were detected. There was large variation in price paid for the antihypertensive medicines (range ₦150 to ₦9,750). Of the 24 pharmacy outlets surveyed, 46% stated that patients did not always require a prescription and 21% had previously reported a medicine as falsified or substandard. CONCLUSIONS: More than one-quarter of some commonly prescribed antihypertensive medicines available in Nigeria may be of substandard quality. Enhanced quality assurance processes in low- and middle-income countries, such as Nigeria, are needed to support optimum management.


Asunto(s)
Amlodipino/normas , Antihipertensivos/normas , Medicamentos Genéricos/normas , Lisinopril/normas , Amlodipino/química , Antihipertensivos/química , Composición de Medicamentos/normas , Medicamentos Genéricos/química , Humanos , Lisinopril/química , Nigeria , Farmacias/estadística & datos numéricos , Salud Rural , Salud Urbana
14.
Am J Health Syst Pharm ; 76(9): 591-598, 2019 Apr 17.
Artículo en Inglés | MEDLINE | ID: mdl-31361828

RESUMEN

PURPOSE: The surface contamination levels of 5 commonly used hazardous drugs in hospital pharmacies are summarized, identifying practice patterns associated with contamination. METHODS: Contamination testing data were compiled to evaluate surface contaminants of 5 hazardous drugs (docetaxel, paclitaxel, cyclophosphamide, ifosfamide, and 5-fluorourcil). Data from 5,842 wipes over 6 years were collected from 338 hospital pharmacies. The contamination level for each drug was categorized as nondetectable (ND; ≤10 ng/ft2), low (between 10 and ≤100 ng/ft2), medium (between 100 and ≤1,000 ng/ft2) or high (>1,000 ng/ft2). Surface exposures for each drug were summarized based on location, contamination at first and subsequent wipe events, and the use of a closed system transfer device (CSTD). RESULTS: The majority of contamination results corresponded to locations at or near hazardous drug preparation, but also occurred in areas where hazardous drugs were not prepared. There was a higher incidence of contamination levels (high, medium, and low, respectively) at first wipe event (10.2%, 17.4%, and 17.7%) compared to subsequent wipe events (5.8%, 12.2%, and 13.6%) (p < 0.0001). There was a lower incidence of contamination levels at institutions that used CSTDs (6.3%, 12.8%, and 14.4%) compared to institutions that did not use CSTDs (14.2%, 17.9%, and 17.3%) (p < 0.0001). CONCLUSIONS: The majority of highest contamination levels corresponded to locations where hazardous drugs were prepared. While the rate of contamination was lower at subsequent wipe events and at institutions that used CSTDs, contamination was not completely eliminated in either scenario.


Asunto(s)
Antineoplásicos/análisis , Contaminación de Equipos/prevención & control , Sustancias Peligrosas/análisis , Servicio de Farmacia en Hospital/normas , Composición de Medicamentos/métodos , Composición de Medicamentos/normas , Monitoreo del Ambiente/métodos , Equipos y Suministros de Hospitales/normas , Humanos , Servicio de Farmacia en Hospital/métodos
15.
Am J Health Syst Pharm ; 76(9): 599-607, 2019 Apr 17.
Artículo en Inglés | MEDLINE | ID: mdl-31361829

RESUMEN

PURPOSE: This study investigates the use of a canopy-connected recirculating class II type A2 biological safety cabinet (BSC) as an alternative to the B2 when preparing volatile, sterile compounded preparations. Selection of the appropriate BSC for processes that use subgram levels of volatile chemicals is difficult due to a lack of quantitative containment evidence by cabinet type. There is a perception that hazardous compounding must be done in a B2 cabinet due to the potential for vapors, and this study seeks to challenge that perception. METHODS: In total, 5 tests, 3 prequalification tests and 2 containment capability tests, were conducted on a single cabinet of each type at sterile compounding pharmacies. Prequalification tests were performed to verify that each BSC was operating properly. Each cabinet was certified to NSF-ANSI 49-2016, particle counted per ISO 14644-1:1999, and subjected to a qualitative video smoke study. Once these tests confirmed the expected working conditions, 2 containment capability tests were conducted. The containment testing included tracer gas testing per ASHRAE 110:2016 section 8.1.1 through 8.1.13, and cyclophosphamide sampling during sterile compounding of the drug material. RESULTS: Both cabinets passed all the prequalification tests. During the ASHRAE tracer gas testing the A2 cabinet was able to contain a tracer gas 92% to 160% as effectively as the B2 cabinet depending on the position of the gas ejection. During sterile compounding the airborne cyclophosphamide sampling captured samples of less than 1.0 ng at all locations for both the A2 and B2 cabinets. CONCLUSION: The data generated from this study demonstrate that use of an A2 for hazardous compounding can provide a comparable level of safety for the environment, users, and product while having less stringent airflow requirements relative to a B2. The simpler requirements for an A2 make them an appealing alternative as they have the potential to reduce the overall operating costs associated with a compounding pharmacy while maintaining safe levels of containment.


Asunto(s)
Contención de Riesgos Biológicos/instrumentación , Composición de Medicamentos/instrumentación , Servicios Farmacéuticos/normas , Antineoplásicos Alquilantes/análisis , Contención de Riesgos Biológicos/normas , Ciclofosfamida/análisis , Composición de Medicamentos/normas , Contaminación de Equipos/prevención & control , Sustancias Peligrosas/análisis , Humanos
17.
J Oncol Pharm Pract ; 25(8): 1979-1986, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31203716

RESUMEN

BACKGROUND: Onkofar Health Devices Inc. offers solutions and service for safe and accurate preparation of anticancer agents. Due to the necessity of specific instructions for the drug preparation systems and the widespread use of services including personnel, the company has to train the personnel employed as oncology pharmacy practitioner technicians. PURPOSE: This study aimed to investigate the contribution of the training program to the theoretical knowledge and the opinions of the participants about the training by retrospectively analyzing the related data. METHODS: The training program consisted of a comprehensive theoretical part and an applied practical part. Participants took pre-tests and post-tests and filled out a standard training evaluation form. Between November 2014 and September 2018, 100 people participated in the training. This study included 71 participants' pre-test and post-test results and 72 participants' evaluation forms. RESULTS: The test results showed that the post-test score was higher in all participants. There was a 34% increase between the average of scores. The improvement percentage was at least 9%, whereas the most considerable improvement was 61%. Overall, almost all of the participants conveyed their positive thoughts about the training. The participants' interest seemed to be mostly related to their applied practice. CONCLUSIONS: Increased post-test scores showed an increase in theoretical knowledge level. The training was found to meet the expectations and needs to a great extent. Participants' opinions contributed to the shaping of the educational content for future training programs. This study showed that the training program provided improvement and value for participants.


Asunto(s)
Composición de Medicamentos/normas , Servicios Farmacéuticos/organización & administración , Farmacias/organización & administración , Técnicos de Farmacia/organización & administración , Antineoplásicos/administración & dosificación , Humanos , Evaluación de Programas y Proyectos de Salud , Estudios Retrospectivos
18.
AAPS PharmSciTech ; 20(5): 208, 2019 Jun 03.
Artículo en Inglés | MEDLINE | ID: mdl-31161450

RESUMEN

Individualized medicines for pediatrics are a useful alternative if there is no correct dosage marketed for this segment (easy to swallow, adequate volume and content, correct composition for pediatrics, good organoleptic properties, etc.). Its validation process must ensure quality testing: its content uniformity, physical (homogeneity after shaking), chemical, and microbiological stability. Some of these attributes are checked by the recommendations of European Pharmacopoeia (Ph. Eur.), International Conference of Harmonization (ICH), and National Formularies but others are not. The aim of this study is to develop a general high-demanding strategy to ensure the final quality of liquid dosage forms testing and developing standard operating processes (SOPs) for the elaboration of individualized oral liquid medicines for pediatric use. Furosemide was used as an example of the validation of an individualized liquid solution for pediatric use. Three SOPs were selected according to their composition and the recommendations of liquid dosage forms for pediatric use. Quality attributes according to National Formularies, Ph. Eur., and ICH were tested: pH, organoleptic properties, uniformity of mass of delivered dose from multidose containers, and chemical stability. In this study, a general high-demanding strategy was elaborated to validate oral liquid dosage forms, including validation of the analytical method used to test their quality. A second part focuses on the elaboration of liquid formulations for pediatrics with the highest standards of quality taking into account CQAs that were not contemplated by official compendial such as content uniformity and physical stability.


Asunto(s)
Excipientes/normas , Furosemida/normas , Pediatría/normas , Medicina de Precisión/normas , Administración Oral , Niño , Diuréticos/administración & dosificación , Diuréticos/normas , Composición de Medicamentos/métodos , Composición de Medicamentos/normas , Excipientes/administración & dosificación , Furosemida/administración & dosificación , Humanos , Pediatría/métodos , Soluciones Farmacéuticas/administración & dosificación , Soluciones Farmacéuticas/normas , Medicina de Precisión/métodos
19.
Drug Dev Ind Pharm ; 45(9): 1523-1536, 2019 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-31215822

RESUMEN

The aim of this work was to investigate the mean fill weight control of a continuous capsule-filling process, whether it is possible to derive controller settings from an appendant process model. To that end, a system composed out of fully automated capsule filler and an online gravimetric scale was used to control the filled weight. This setup allows to examine challenges associated with continuous manufacturing processes, such as variations in the amount of active pharmaceutical ingredient (API) in the mixture due to fluctuations of the feeders or due to altered excipient batch qualities. Two types of controllers were investigated: a feedback control and a combination of feedback and feedforward control. Although both of those are common in the industry, determining the optimal parameter settings remains an issue. In this study, we developed a method to derive the control parameters based on process models in order to obtain optimal control for each filled product. Determined via rapid automated process development (RAPD), this method is an effective and fast way of determining control parameters. The method allowed us to optimize the weight control for three pharmaceutical excipients. By conducting experiments, we verified the feasibility of the proposed method and studied the dynamics of the controlled system. Our work provides important basic data on how capsule filler can be implemented into continuous manufacturing systems.


Asunto(s)
Composición de Medicamentos/métodos , Modelos Teóricos , Control de Calidad , Cápsulas , Composición de Medicamentos/normas , Excipientes , Estudios de Factibilidad , Polvos
20.
Int J Pharm Compd ; 23(2): 123-130, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31085778

RESUMEN

Process analytical technology was introduced by the U. S. Food and Drug Administration about 20 years ago to assist the pharmaceutical industry in making changes that should reduce batch failures, ensure performance, and enhance quality. Its premise is that "quality cannot be tested into preparations; it must be built-in or should be by design." One proposed advantage was to reduce end-product testing by ensuring each process was functioning properly. In compounding, there are a number of processes that could be advantageously incorporated into process analytical technology since end-product testing is not generally done due to the nature of compounding. The purpose of this article is simply to introduce the concept of process analytical technology into compounding with the understanding that it will take a number of years for it to be evaluated and implemented, even on a small scale. It is not feasible to do it all at once; just one step at a time. Since patient safety is uppermost in compounding, this concept should be considered.


Asunto(s)
Composición de Medicamentos , Contaminación de Medicamentos , Esterilización , Composición de Medicamentos/normas , Contaminación de Medicamentos/prevención & control , Industria Farmacéutica , Humanos , Control de Calidad , Esterilización/normas , Estados Unidos , United States Food and Drug Administration
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