Pharmaceutical Validation Research Articles

Method Development and Validation of Stability-Indicating HPLC-UV Method for Determination of 5 -Fluorouracil

Introduction: In the realm of pharmaceutical analysis, the development and validation of a High-Performance Liquid Chromatography with Ultraviolet Detection (HPLC-UV) method for the precise determination of 5-FU stand as a crucial endeavor. Methods: This study outlines the systematic process of method development, optimization, and subsequent validation to ensure the reliability and applicability of the method in pharmaceutical quality control. Method optimization included the selection of an appropriate stationary phase, mobile phase composition, and chromatographic conditions to achieve optimum resolution, sensi-tivity, and run time. Results: A speedy, simple, and dependable HPLC technique for quantifying 5-FU on a C18 (250 4.6 mm, 5m particle size) column with solvent A included 10 mM phosphate buffer with pH 3.0 and solvent B with acetonitrile as the mobile phase. At 250 nm, the effluent was measured. Fur-ther, 5-FU had a retention time of 1.698 minutes. Conclusion: According to ICH criteria, the devised technique was validated for precision, accu-racy, linearity range, robustness, and ruggedness.

Enhancing antibiotic prescribing practices at the main military training hospital of Tunis: A study of pharmaceutical interventions

Bacterial infections have historically posed significant challenges until the discovery of antibiotics, which revolutionized infectious disease treatment. However, bacterial adaptation mechanisms over time have led to increased antimicrobial resistance, necessitating judicious antibiotic use. This study aims to comprehensively analyze pharmaceutical interventions related to antibiotic prescriptions governed by antibiotic order forms to identify and rectify medication errors, optimizing antibiotic prescribing practices. Approval for this research was obtained from the institutional review board of the Main Military Training Hospital of Tunis, Tunisia. A retrospective study was conducted at the main military training hospital of Tunis over 4 months. Pharmaceutical validation of antibiotic prescriptions through antibiotic order forms was conducted by a pharmacy resident. Pharmaceutical interventions were initiated upon detection of errors, and patient records were accessed through institutional software. Out of 1100 prescription forms analyzed, 41 pharmaceutical interventions were conducted for 7 antibiotics. Twenty-four percent of all interventions were related to antibiotic order forms, with the intensive care unit accounting for the highest number of errors. Under-dosage and prescription errors were common. Our pharmaceutical interventions related to antibiotic order forms are crucial for optimizing antibiotic therapy. Feedback mechanisms to healthcare teams are essential for enhancing prescription quality and patient care outcomes. Ongoing surveillance and improvement efforts are necessary to address medication errors and enhance antimicrobial stewardship.

Impact of pharmaceutical validation on prescribing errors in a neonatal intensive care unit. Randomised and controlled study.

To compare the frequency of electronic prescription errors when the prescription was validated by the clinical pharmacist vs. when it was not. This prospective randomised controlled study was conducted in three phases. A randomised phase, in which patients were divided into control and intervention groups, and a pre- and post-intervention phase were consecutively performed to analyse the impact of pharmaceutical validation of prescriptions in a neonatal intensive care unit (NICU). This study was performed at a highly complex NICU at a tertiary hospital. All patients born during the study period who were admitted to the NICU, with a stay lasting ≥24 h, and received active pharmacological treatment were included in the study. Pharmaceutical validation was performed according to the paediatric pharmaceutical care model. A high level of validation was selected for this study. In the intervention group, discrepancies found during the review process were communicated to the medical team responsible for the patients and resolved on the same day. In total, 240 patients were included in this study. Sixty-two patients were allocated to the pre-intervention (n = 38) or post-intervention (n = 24) groups, and 178 patients were randomly sorted into two groups, control (n = 82 newborns) and intervention (n = 96 newborns). During the randomisation phase, the number of prescription errors detected was significantly lower in the intervention group than that in the control group (129 vs. 270; p < 0.001). Similarly, prescription errors reaching the patient were significantly reduced from 40% (n = 108) in the control group to 1.6% (n = 2) in the intervention group. In the pre- and post-intervention periods, the prescription lines containing prescription errors decreased from 3.4% to 1.5% (p = 0.005). This study showed that the pharmaceutical validation process decreased both the number of errors in the electronic prescribing tools and the number of prescription errors reaching the patient.

MODELLING AND SIMULATION OF NONLINEAR DYNAMIC FLOW FIELD AND TEMPERATURE FIELD OF DEPYROGENATION TUNNEL

Nonlinear dynamics plays a crucial role particularly in equipment validation of preparation production, validation results of which will significantly influence the results and period of drug registration in drug production processes. In this research, the flow field and temperature field simulation, calculation and analysis are creatively carried out in terms of depyrogenation tunnel, a very popular preparation drying-sterilization equipment in pharmaceutical processes with strong dynamic characteristics. After construction of 3D model of this equipment using Catia and mesh generation applying ANSYS, the computational fluid dynamic (CFD) method and verification of irrelevance method are carried out regarding 6.05 million of meshes to identify the flow velocity model and heat transfer model inside the equipment, to further provide methodology for pharmaceutical process validation and to further optimize the design of control methods. After calculation and simulation, the low-velocity vortices of different sizes inside the hood and the drying chamber are identified, which could cause vials to fall down; meanwhile, vials that are farther away from the outlet receives less heat exchange effect, which would shrink the effective sterilization area, indicating an inadequate validation methodology in pharmaceutical processes.

P646 Clinical decision support in the prevention of adverse effects associated with immunosuppressive drugs in patients with Inflammatory Bowel Disease

Abstract Background With the goal of effective and early prevention and detection of medication-related adverse effects, an explosion of technological advances is taking place. However, none of these systems are currently intelligent enough to ensure safe prescribing of treatments on their own. Purpose To design and integrate clinical decision rules (CDR) to increase the safety of immunosuppressive treatments in patients with inflammatory bowel disease (IBD) into an electronic prescribing assistance software (HIGEA). Methods This is a descriptive study conducted in a tertiary university hospital in Madrid (Spain). 1. We reviewed the technical product information sheet of the immunomodulatory drugs used in the treatment of patients with IBD and the current recommendations and clinical practice guidelines on the management of IBD. 2. The CDR were developed within a multidisciplinary team of physicians and pharmacists by integrating data from pharmacogenetics, microbiology, biochemistry, immunology and haematology laboratories, the electronic medical record and the electronic prescribing programme. 3. Integration was performed using a standard language (HL7). Results The technical product information sheet of 33 immunomodulatory drugs (19 biological therapies, 6 small molecules and 8 traditional disease-modifying drugs) and the clinical practice guidelines for the treatment of IBD of the European Crohn's and Colitis organisation (ECCO) and the Spanish working group on Crohn's disease and ulcerative colitis (GETECCU) were reviewed. A total of 169 CDR were developed: 2 related to pharmacogenetics laboratory values, 26 to microbiology, 38 to biochemistry, 24 to immunology, 42 to haematology, 28 to clinical history and 9 related to concomitant use of other drugs. Of the 169 CDR, 50 (29.58 %) were related to screening prior to initiation of immunosuppressive treatment, 10 (5.92%) to drug interactions and 109 (64.5%) related to clinical conditions requiring adjustment or discontinuation of immunosuppressive treatment. Conclusion The incorporation of personalised clinical rules into the medical prescription and pharmaceutical validation process will allow the selection of patients in whom there could be a safety problem with immunosuppressive treatment, increasing the percentage of early detected and avoided adverse events. Future steps will be to evaluate the impact of the implementation of the CDR tool on increasing safety, reducing healthcare costs and improving patient health outcomes.

Exploring the complexities of drug formulation selection, storage, and shelf-life for exploration spaceflight.

Medications have been a part of space travel dating back to the Apollo missions. Currently, medical kits aboard the International Space Station (ISS) contain medications and supplies to treat a variety of possible medical events. As we prepare for more distant exploration missions to Mars and beyond, risk management planning for astronaut healthcare should include the assembly of a medication formulary that is comprehensive enough to prevent or treat anticipated medical events, remains safe and chemically stable, and retains sufficient potency to last for the duration of the mission. Emerging innovation and technologies in pharmaceutical development, delivery, quality maintenance, and validation offer promise for addressing these challenges. The present editorial will summarize the current state of knowledge regarding innovative formulary optimization strategies, pharmaceutical stability assessment techniques, and storage and packaging solutions that could enhance drug safety and efficacy for future exploration spaceflight missions.

Nirmatrelvir/ritonavir drug-drug interactions in primary care outpatients

The oral antiviral nirmatrelvir/ritonavir interacts with a range of drugs. Candidate patients to receive this antiviral agent are usually vulnerable, multipathological and polymedicated. The objective is to evaluate the pharmaceutical validation prior to the administration of the antiviral. Drug-drug interactions between nirmatrelvir/ritonavir and patients' usual treatment medications were checked in product information and in the UpToDate® and the University of Liverpool® interaction tools. We included validated prescriptions between April/2022 and April/2023 by a Primary Care pharmacist. Of the 159 study patients, 168 interactions were found in 83 individuals, which may have led to changes of their usual treatment. Statins (25.6%), anticoagulants (10.7%), and antihypertensives (10.7%) were the most frequently implicated therapeutic groups. Discontinuation (53.0%) and dose reduction (22.6%) were the most common treatment changes. Our search of potential drug interactions and subsequent dose adjustments and modifications of the patient's usual treatment has helped avoid potential toxicities ensuring a safe use of nirmatrelvir/ritonavir.

Establishment of the mechanism of purification and levigation of green chemistry-assisted biocomposites of red ochre (Gairika): synthesis, characterization, and antibacterial, prebiotic, antioxidant, and antacid activities of the traditional Ayurvedic medicine Laghu Sutashekhara Rasa

Gairika (red ochre) has a long history of influencing human civilization. Gairika is a rich source of nutrients used for reproductive and brain health. Gairika is mentioned as an antacid drug in Indian Ayurvedic medicine under Laghu Sutashekhara Rasa (LSR). However, a detailed study on LSR has not been reported to date. In the present study, LSR was prepared, and a pharmaceutical SOP (standardization procedure) was reported to obtain batch-to-batch reproducibility. LSR was characterized using FTIR, XRD, SEM-EDX, and TGA analyses. LSR was tested in vitro for its antacid activity. Advanced instrumentation revealed that LSR formation produced symmetrical particles (5–8 µm) with kaolin, kaolinite, quartz, goethite, and hematite, along with the phytoconstituents of Goghrita (clarified cow’s butter), Shunthi, and Nagawalli, as confirmed by GC-MS/MS analysis. The FTIR study revealed the formation of a chelating complex of goethite and hematite along with their phytoconstituents. XRD analysis confirmed the presence of kaolin, kaolinite, quartz, goethite, and hematite. Using in vitro antacid experiments, LSR and Shunthi demonstrated significant antacid activity as compared to antacid drugs and standards in the market, such as CaCO3. The DPPH assay revealed IC50 values of 12.16 ± 1.23 mg/mL, which is 0.0029 of Trolox-equivalent antioxidant activity. The inhibition (18 ± 4 mm) against pathogens (S. aureus, E. coli, P. aeruginosa, and B. subtilis) and the prominent growth of gut microbiota-supported strains (S. boulardii, L. paracasei, and L. plantarum) observed on LSR formulation were indicative of LSR application as a prebiotic. Here, the mechanism of purification and levigation mentioned in the classical literature of LSR was established. Overall, purification of Gairika with cow ghee and levigation with Nagawalli may enhance the solubility, bioavailability, and shelf-life of LSR through hydration and co-crystallization mechanisms. This is the first comprehensive report on the pharmaceutical validation of LSR and its characterization. The results of the present study could contribute to the development and reliable reproduction of LSR and the utility of environmental red ochre as a medicine in combination with Shunthi (Zingiber officinale Roxb.), as prescribed under Indian Ayurvedic medicine.

Cannabis as a Source of Approved Drugs: A New Look at an Old Problem

Cannabis plants have been used in medicine since ancient times. They are well known for their anti-diabetic, anti-inflammatory, neuroprotective, anti-cancer, anti-oxidative, anti-microbial, anti-viral, and anti-fungal activities. A growing body of evidence indicates that targeting the endocannabinoid system and various other receptors with cannabinoid compounds holds great promise for addressing multiple medical conditions. There are two distinct avenues in the development of cannabinoid-based drugs. The first involves creating treatments directly based on the components of the cannabis plant. The second involves a singular molecule strategy, in which specific phytocannabinoids or newly discovered cannabinoids with therapeutic promise are pinpointed and synthesized for future pharmaceutical development and validation. Although the therapeutic potential of cannabis is enormous, few cannabis-related approved drugs exist, and this avenue warrants further investigation. With this in mind, we review here the medicinal properties of cannabis, its phytochemicals, approved drugs of natural and synthetic origin, pitfalls on the way to the widespread clinical use of cannabis, and additional applications of cannabis-related products.

Development of a carbocysteine 10% + urea 5% cream for the topical treatment of congenital ichthyosis

ObjectiveOptimization of a topical formula of N-acetylcystelne and urea for the topical treatment of ichthyosis. MethodWe reviewed the chemical structure of the N-acetylcysteine molecule and its metabolic processes. A search was conducted of possible alternative molecules with a chemical structure similar to that of N-acetyl- cysteine that could have improved organoleptic properties. The following databases were used: PubChem®, Botplus®, the Drug Information Centre of the Spanish Agency of Medicines and Medical Devices. The molecule selection criteria were as follows: structural similarity, same therapeutic group, same mechanism of action, same authorized indication, absence of unpleasant smell, and being marketed as raw material in Spain. To complete the pharmaceutical development and validation of the compound, several tests and controls were conducted following the emulsion production procedure of the National Formulary. In order to establish the validity period, we followed the recommendations of the “Guide to Good Drug Preparation Practices in Hospital Pharmacy Services”. ResultsN-acetylcysteine has a free sulfhydryl group, which is responsible for its smell, and undergoes deacetylation. Its main metabolites are cystine and cysteamine. The following molecules were assessed: cystine, cyst eamine, carbocisteine, cysteine and methionine. Carbocisteine was selected because it met all the selection criteria. Carbocisteine is practically insoluble in water and soluble in mineral acids and alkaline hydroxides solutions. Unlike N-acetylcysteine, it does not have a fetid smell. It reaches its maximum stability at pH 5.5 to 7.5. The composition of the compound (100 g) was as follows: carbocisteine (10 g), urea (5 g), glycerine (15 g), water (44 mL), sodium hydroxide (1 g), and Neo PCL® Oil/Water (O/W) (25 g). It has an expiration period of 30 days. The organoleptic characteristics, emulsion type, and pH remained stable within the established expiration period. The carbocisteine compound has been incorporated into the group of topical treatments available for the treatment of patients with ichthyosis in our hospital. ConclusionsThe carbocisteine molecule is a good therapeutic alternative that lacks the unpleasant smell of N-acetylcysteine. The carbocisteine compound developed has been included as topical treatment for ichthyosis due to its tolerability, acceptability, and effectiveness in the treatment of patients affected by this genodermatosis.

Hospital Pharmacist experience in the Intensive Care Unit: Plan COVID

The Intensive Care Unit (ICU) of the University Hospital of Fuenlabrada was forced to critically increase its capacity in the COVID-19 pandemic. The objective of this work is to describe the activities promoted by the pharmacist in the care of the critically ill patient in this context.A new organizational structure was designed, analyzing the tasks necessary to make the processes profitable. Two pharmacists joined the critical patient care to help the pharmacist who was already integrated in the ICU team.The development of the operational structure was carried out on three levels.The healthcare activity highlights the daily participation of pharmacists in the two clinical sessions in which the ICU teams evaluated all cases and made decisions. This in turn facilitated the pharmaceutical validation that was carried out in the critical units themselves. In addition, one of the pharmacists created the Immuno-COVID Committee, in which they participated together with different specialists for therapeutic decision-making in the most complex cases.On the other hand, the availability of human and material resources allowed the implantation of centralized elaboration in the Pharmacy Service of many intravenous mixtures, including antibiotics elastomers Pumps for continuous infusion, and non-sterile elaborations.In logistics management, in addition to the acquisition of COVID-19 therapies, the reconciliation with nursing activity stands out. The physical presence of the pharmacist favored the detection of needs, the availability in time of medications in the unit, including sterile and non-sterile preparations, and coordination with the central pharmacy.In knowledge management, the participation of the pharmacist in the working group for the development of the hospital management protocol COVID-19 stands out.The daily presence in the unit and the joint work with the entire multidisciplinary team demonstrate the value that the pharmacist can bring. In addition to efficient resource management, support for clinical decision-making and improvement actions, it provides the climate of inter-professional trust necessary to respond to the complexity of the critical patient and promote joint projects.

Pharmaceutical services in nursing homes in Spain

ObjectiveTo describe the current situation regarding the specialized pharmaceutical service provision in nursing homes in Spain, from a healthcare perspective reflecting activity, care and services provided. MethodObservational, cross-sectional, multicenter study conducted between February-June 2018 through a survey aimed at all Hospital Pharmacy Units in Spain. Once the initial version was assessed by twelve evaluators whose healthcare assistance work were related to nursing homes, an electronic form was designed, consisting on 10 dimensions and 66 questions. A piloting was carried out by six nursing homes pharmacists. The results were analyzed descriptively. ResultsThe overall response rate was 29.7% (113 out of 380). Out of all studied hospital pharmacy units, 46.0% (n = 52) served nursing homes (9 as Nursing Homes Pharmacy Department) whose characteristics defined a profile of pharmacy unit at hospital, public ownership, consolidation in this activity, with great variability in the number of centers and patients to be attended by service, and with the pharmacist's partial dedication. In 51.3% of cases, nursing homes professionals were represented at pharmacy and therapeutic committees, while 38.5% were from pharmacy services who participated in the selection of medical devices. Also, 67.4% performed an integral management of the therapy. The study has also shown that 34.6% counted on assisted electronic prescription, while 88.5% performed a pharmaceutical validation of the prescription prior to dispensing, which in 71.2% of cases consisted of individualized unit doses. It was found that 42.3% performed a third-level treatment comprehensive review, and 25.0% participated in the interdisciplinary nutritional assessment. It also showed that 34.6% actively participated in either comprehensive geriatric assessment, or clinical cases in interdisciplinary teams, and 46.2% counted on programs for the safe use of medicines. ConclusionsThe specialized pharmaceutical care at nursing homes is a reality, although it presents important differences in essential aspects for the quality of the assistance provided. It is necessary to go in-depth on the care model to be developed, as well as having a greater involvement of pharmacy services to achieve a comprehensive and person-centered care.

Quality by Design Approach: Progress in Pharmaceutical method Development and Validation

Pharmaceutical analysis plays a significant role in pharmaceutical formulation quality assurance and control. Due to the pharmaceutical industries' rapid expansion and the production of pharmaceuticals all over the world, there is a greater need for novel analytical procedures in this sector. Establishing the identification, purity, physical properties, and potency of medications as well as the medication's bioavailability and stability is the goal of analytical method development. A few new drug applications were recently given regulatory flexibility by the Food and Drug Administration for an analytical method based on quality by design. With Quality by design, product design and development are performed methodically. Analytical methodologies have similar opportunities for implementing Quality by design as production procedures do. It consequently enhances formulation design, development efficiency, and capacity. The underpinnings of the QbD approach have been explored in this article due to their use in the creation and validation of analytical procedures. Additionally, a summary of experimental studies reporting the application of the QbD methodology to method development is included.

Analytical Method Development and Validation for Estimation of Lapatinib in Formulation by RP-HPLC with Stability Indicating

Reverse-phase high-performance liquid chromatography (RP-HPLC) approach for Lapatinib in pharmaceutical dosage form development and validation. Reverse phase chromatography is easy, practical, and superior in terms of effectiveness, stability, and repeatability. Lapatinib was chosen to be separated using the C18 column, a 250 x 4.6 mm column with 5.0µm particle packing. As lapatinib was exhibiting good peak morphologies and a large amount of resolution, it was created with a mobile phase of water, methanol, and trifluroacetic acid (30:70:0.1) v/v. The analytes were detected at 262nm using a UV detector while the mobile phase was flowing at 1.1 ml/min. Specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantitation were used to develop the method and validate it.The method demonstrated a dynamic linear response at 25-75 µg/ml and was shown to be linear with a correlation coefficient (r2) of above 0.999 and limits of detection and quantitation (LOD and LOQ) of 0.45 and 1.35µg, respectively. Degradation of the sample was used to establish the stability indicating RP-HPLC procedures, which were then compared to standards. The relative standard deviation as a percentage was also less than 2%, demonstrating the suggested method's high level of precision.

Development of an immediate release excipient composition for 3D printing via direct powder extrusion in a hospital

3D printing offers the possibility to prepare personalized tablets on demand, making it an intriguing technology for hospital pharmacies. For the implementation of 3D-printed tablets into the digital Closed Loop Medication Management system, the required tablet formulation and development of the manufacturing process as well as the pharmaceutical validation were conducted. The goal of the formulation development was to enable an optimal printing process and rapid dissolution of the printed tablets for the selected model drugs Levodopa/Carbidopa. The 3D printed tablets were prepared by direct powder extrusion. Printability, thermal properties, disintegration, dissolution, physical properties and storage stability were investigated by employing analytical methods such as HPLC-UV, DSC and TGA. The developed formulation shows a high dose accuracy and an immediate drug release for Levodopa. In addition, the tablets exhibit high crushing strength and very low friability. Unfortunately, Carbidopa did not tolerate the printing process. This is the first study to develop an immediate release excipient composition via direct powder extrusion in a hospital pharmacy setting. The developed process is suitable for the implementation in Closed-Loop Medication Management systems in hospital pharmacies and could therefore contribute to medication safety.

Characterization of drug and non-drug interactions in patients treated in medical oncology.

e15110 Background: Oncology patients frequently get multiple medications, including herbal supplements and medicines (chemotherapy, supportive care, comorbidities drugs, self-medication). This might pose a serious risk for drug interactions (DI) and non-drug interactions (NDI), which could endanger the patient's health. Our aims are to characterize the interactions, describe the risks to the patient they pose, and suggest a course of action to be followed. Methods: To make a pharmaceutical validation of chemotherapy prescriptions, this prospective study—the first of its kind at the national level—was carried out at the level of the Medical Oncology Department of CHU-Tlemcen from November 2021 to February 2022. It included patients treated on an outpatient basis who were receiving chemotherapy and/or targeted therapy. Following a medication reconciliation interview, patients from our sample who are being treated for one or more comorbidities are chosen in order to detect DIs using two French platforms (Vidal, Theriaque) and one Anglo-Saxon platform (Drugs). Hedrine was utilized to detect NDIs. Results: A total of 76 patients were enrolled for chemotherapy pharmaceutical validation. 36 (47%) of them were interviewed (median age = 61 years [42-86], sex ratio = 0,2), had at least one comorbidity treatment and 16 patients (45%) had breast cancer. The most frequently used protocols were anthracyclines (10 patients; 28%), anthracycline-taxanes (5 patients; 14%), capecitabine (5 patients; 14%), and capecitabine-oxaliplatin (3 patients; 8%). Seven patients (19%) used herbal supplements, primarily black seed ( Nigella sativa L.). Forty different interactions were listed for Vidal (23 precautions for use, 18 to be considered), 4 involved a chemotherapy drug. Forty-seven interactions with Theriaque (7 new interactions that Vidal missed, including 5 undesirable associations due to the use of ethanol as an excipient with a notable effect), 8 were due to a chemotherapy drug. On Drugs, 102 interactions were observed (4 serious, 90 moderated, and 8 minor), 38 involved a chemotherapeutic agent. Most interactions necessitated clinical and/or biological patient monitoring. In terms of NDIs, Hedrine indicates possible interactions by cross-referencing the effects of different plants on the organism with those of drugs, without giving any indication of the level of risk, what to do in case of risk. This makes interpretation difficult and requires expert opinion to guide action. No serious events were reported in the study. Conclusions: It is worthwhile to continue the pharmaceutical interview, especially for those most at risk for drug interactions, i.e., the elderly and/or patients on multiple medications. To widen the scope of interaction detection, it should be carried out prior to the recommendation of chemotherapy and refreshed when a patient's protocol changes utilizing at least one French and one Anglo-Saxon database.

A Review on Pharmaceutical Cleaning Validation

The goal of this review is to establish the significance of cleaning validation in the pharmaceutical industry. Pharmaceutical product and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms or by other materials e.g. air borne particles, dust, lubricants, raw materials, intermediates, etc. Cleaning procedure is the process of assuring that cleaning procedures effectively remove the potentially dangerous substances from equipments. This can be minimized by proper cleaning of equipment, apparatus as well as the processing area. So it is necessary to validate the cleaning procedures to ensure safety, efficacy, quality of the subsequent batches of drug product and regulatory requirements in Pharmaceutical product manufacture. It briefly provides an overview on mechanism of contamination, cleaning mechanisms, cleaning agents, procedure of cleaning, and sampling techniques.

A Comprehensive Review of Deflazacort with Special Reference to Pharmacological Profile and Pharmaceutical Validation Processes

Deflazacort is a prednisolone-derived immunosuppressant and anti-inflammatory. It controls cytokines and immune cell development. It may increase muscle cell proliferation and reduce muscle breakdown to enhance Duchenne muscular dystrophy muscle strength and function. Pharmaceutical companies aim to produce high-quality drugs at low prices. Pharmaceutical formulation discovery, development, and evaluation require validated methods. Validation ensures quality and reliability throughout the manufacturing process. The validation procedure evaluates accuracy, specificity, precision, and system applicability to guarantee the analytical technique used to analyze medicine-related samples is reliable. This paper describes the deflazacort technique development and validation. Google Scholar, Pub-Med, and Shodganga are utilized to gather information.

Pharmaceutical Interventions on Hospital Discharge Prescriptions: Prospective Observational Study Highlighting Challenges for Community Pharmacists.

BackgroundTransition between hospital and ambulatory care is a delicate step involving several healthcare professionals and presenting a considerable risk of drug-related problems.ObjectiveTo investigate pharmaceutical interventions made on hospital discharge prescriptions by community pharmacists.MethodThis observational, prospective study took place in 14 community pharmacies around a Swiss acute care hospital. We recruited patients with discharge prescriptions (minimum three drugs) from the internal medicine ward of the hospital. The main outcome measures were: number and type of pharmaceutical interventions made by community pharmacists, time spent on discharge prescriptions, number of medication changes during the transition of care.ResultsThe study included 64 patients discharged from the hospital. Community pharmacists made a total of 439 interventions; a mean of 6.9 ± 3.5 (range 1–16) interventions per patient. All of the discharge prescriptions required pharmaceutical intervention, and 61 (95%) necessitated a telephone call to the patients’ hospital physician for clarifications. The most frequent interventions were: confirming voluntary omission of a drug (31.7%), treatment substitution (20.5%), dose adjustment (16.9%), and substitution for reimbursement issues (8.8%). Roughly half (52%) of all discharge prescriptions required 10–20 min for pharmaceutical validation. The mean number of medication changes per patient was 16.4: 9.6 changes between hospital admission and discharge, 2.6 between hospital discharge and community pharmacy, and 4.2 between community pharmacy and a general practitioner’s appointment.ConclusionHospital discharge prescriptions are complex and present a significant risk of medication errors. Community pharmacists play a key role in preventing and identifying drug-related problems.

Potentially Inappropriate Medication Prescribing Detected by Computer Algorithm among Older Patients: Results from the MAPT Study.

(1) Background: Some medications may be dangerous for older patients. Potentially inappropriate medication prescribing (PIP) among older patients represents a significant cause of morbidity. The aim of this study was to create an algorithm to detect PIP in a geriatric database (Multidomain Alzheimer Preventive Trial (MAPT) study), and then to assess the algorithm construct validity by comparing the prevalence of PIP and associated factors with literature data. (2) Methods: An algorithm was constructed to detect PIP and was based on different explicit criteria among which the European list of potentially inappropriate medications (EU(7)-PIM), the STOPP and START version 2 tools. For construct validity assessment, logistic mixed-effects model repeated measures analyses were used to identify factors associated with PIP. (3) Results: Prevalence of PIP was 59.0% with the EU(7)-PIM list criteria, 43.2% with the STOPP criteria and 51.3% with the START criteria. Age, polypharmacy, and higher Charlson comorbidity index were associated with PIP. (4) Conclusions: Prevalence of PIP and associated factors are consistent with literature data, supporting the construct validity of our algorithm. This algorithm opens up interesting perspectives both in terms of analysis of very large databases and integration into e-prescribing or pharmaceutical validation software.