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Aim of the work: To determine the relation between Risperidone plasma concentration and its efficacy in patients with schizophrenia to assess the value of therapeutic drug monitoring in clinical practice. Method: In February 2020, a search was conducted in the period from 2000 to 2020 using Google scholar, Pubmed and Science Direct as search engine. The key words used in this search were Risperidone, plasma concentration, schizophrenia. Articles were selected for inclusion in this search if they involved a test for the correlation between plasma concentration and efficacy. Results: Limited number of studies was found. Among 14 studies, 10 yielded no correlation between Risperidone plasma levels and its efficacy while 4 studies showed positive results. To investigate the relation between Risperidone plasma concentration and clinical response, the most common tools used are HPLC for determination of plasma concentration and PANSS for assessment of clinical response. Conclusion: The majority of studies showed no correlation and therapeutic drug monitoring of Risperidone is still unclear. Further research is needed in this area.

Background: Chronic infection with Hepatitis C virus (HCV) is considered as a major cause for developing liver cirrhosis and hepatocellular carcinoma. A new era in HCV treatment is ongoing using Direct Acting Antiviral activity (DAA). The first approved DAA drug was Sofosbuvir which has a high tolerability and preferable pharmacokinetic profile. Another recently developed drug is Daclatasvir a first-in-class HCV NS5A replication complex inhibitor. Both drugs are administered orally once daily and have potent antiviral activity with wide genotypic coverage. Methods: In the outpatient clinic, one hundred and fifty naïve difficult to treat chronic HCV patients were recruited from Tropical Medicine Department at Fayoum public hospital. A combination of Daclatasvir (60 mg) and Sofosbuvir (400 mg) (DCV/SOF) has been administered for those patients once daily with Ribavirin (1200 mg or 1000 mg based on patients’ weight on two divided doses) over a period of 12 weeks. All patients have been followed up for clinical, laboratory assessment and HCV PCR to detect the efficacy and safety of the therapy. Results: Sustained Virologic Response rate (SVR12) was achieved in the vast majority of patients (90.67%). Cirrhotic patients showed lower SVR compared to non-cirrhotic patients (88.89% vs 90.91%, respectively). Around half of the patients (49.33%) developed adverse events (AEs) during treatment. The most common AEs were headache, fatigue and abdominal pain Conclusion: The available evidence seems to suggest that combination therapy of (DCV/SOF with RBV) in the treatment of chronic HCV genotype IV naïve difficult to treat patients either cirrhotic or non-cirrhotic is safe and effective. Monitoring for clinical and laboratory hepatic parameters was the basis for these findings.

Many herbal products have been used to control blood glucose level and minimize complications of diabetes mellitus. However, the feasibility of using such herbal product has been hindered due to the lower stability of their extracts and patients incompliance. Objective: An optimized fast disintegrating tablet preparation of spray dried aqueous extract of poly herbal blend has been formulated to maximize the therapeutic activity of such herbal extract. Methods: different ratios of superdisintegrants were evaluated in terms of reducing disintegration time and wetting time of the prepared formulations. The potential of the optimized formula in reducing blood glucose level and promoting wound healing in STZ-induced diabetic rats was determined. Key finding: Oral administration of the optimized formula (F6) had significant superior effect in reducing blood glucose level and promoting wound healing of diabetic rats compared receiving the aqueous extract of the herbal blend (P

Background Post-COVID-19 symptoms and diseases appeared on many survivors from COVID-19 which are similar to that of the post-severe acute respiratory syndrome (SARS) fatigue. Hence, the study aims to investigate and characterise the manifestations which appear after eradication of the coronavirus infection and its relation to disease severity. Method About 287 survivors from COVID-19 were included in the study, each received a questionnaire divided into three main parts starting from subjects' demographic data, data about the COVID-19 status and other comorbidities of the subject, and finally data about post-COVID-19 manifestations. Response surface plots were produced to visualise the link between several factors. Results Only 10.8% of all subjects have no manifestation after recovery from the disease while a large percentage of subjects suffered from several symptoms and diseases. The most common symptom reported was fatigue (72.8%), more critical manifestations like stroke, renal failure, myocarditis and pulmonary fibrosis were reported by a few percent of the subjects. There was a relationship between the presence of other comorbidities and severity of the disease. Also, the severity of COVID-19 was related to the severity of post-COVID-19 manifestations. Conclusion The post-COVID-19 manifestation is largely similar to the post-SARS syndrome. All subjects recovered from COVID-19 should undergo long-term monitoring for evaluation and treatment of symptoms and conditions that might be precipitated with the new coronavirus infection.

Generally, it has been thought that PEG-conjugated nanocarriers are non-immunogenic. However, many reports have revealed that unexpected immune responses occur with such PEG-conjugated nanocarriers. The Most important one is the rapid clearance of PEGylated nanocarriers upon repeated administration which is called accelerated blood clearance phenomenon involving the production of antibodies against nanocarrier components, which reduces the safety and effectiveness of the encapsulated therapeutic agent. Such immunogenicity of PEGylated nanocarriers is a potential concern in the evaluation and clinic use of PEGylated therapeutics. Accordingly, screening of the immunogenicity of nanocarriers-based therapeutics is a prerequisite before their adoption into clinical settings to disclose any possible interactions with immune system. This review gives an overview of PEGylated liposomes, immunogenicity of PEG, explanation of accelerated blood clearance (ABC) phenomenon, its mechanism, various factors affecting it and side effects of PEGylated liposomes.

Mohamed M Ibrahim,1 Abdulla M Abuelmatty,2 Gehan H Mohamed,3 Mohsen A Nasr,4 Amal K Hussein,5 Mohy El Deen Ebaed,6 Hatem A Sarhan5 1Department of Clinical Pharmacy, Faculty of Pharmacy, Minia University, Minia, Egypt; 2Department of Pharmacy, Jahra Hospital, Jahra, Kuwait; 3Department of Internal Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt; 4Department of Internal Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt; 5Department of Pharmaceutics, Faculty of Pharmacy, Minia University, Minia, Egypt; 6Department of Biochemistry, Egyptian Ministry of Interior, Cairo, Egypt Background: The intensive care unit (ICU) is a center of multidrug-resistant (MDR) pathogens. This is due to overuse of antibiotics in the treatment of critically ill patients. Tigecycline is a broad-spectrum antibiotic that belongs to the glycylcycline group. Tigecycline has been indicated in treatment of complicated intra-abdominal infections (cIAIs) and complicated skin and soft-tissue infections (cSSTIs).Objective: This study was done to discover the best dose regimen of tigecycline in treatment of cSSTIs and cIAIs, especially in patients who are critically ill and obese, for clinical outcomes and safety.Setting: The study was conducted in an adult ICU that consists of 25 beds in a general hospital and was conducted within 2 years. A total of 954 patients were screened in this study.Methods: This was a retrospective cohort study that compared the clinical outcomes of patients: mortality, ICU stay, and safety of using two different dose regimens of tigecycline between patients with different body weight who were treated for infections caused by MDR pathogens in the ICU. The study was conducted within 2 years. All results were collected from patients’ files and were analyzed with SPSS version 20.Main outcome: The study was implemented to figure out the best dose regimen of tigecycline to achieve a reduction in mortality, ICU stay, treatment duration, and secondary septic-shock incidence with minimum side effects in treatment of cSSTIs and cIAIs in patients with different body weight.Results: There was a significant improvement in mortality, ICU stay, recurrent infection by the same organism, duration of tigecycline treatment, number of patients who had first negative culture after starting treatment, secondary bacteremia, and secondary septic shock with patients who used high-dose regimens of tigecycline in different subgroups of body weight, with no significant difference in side effects.Conclusion: The use of high-dose tigecycline resulted in a significant enhancement in all clinical outcomes, especially mortality and ICU stay when used in treatment of overweight and obese patients with cSSTIs and cIAIs. Keywords: tigecycline, obese patients, intensive care unit, complicated intra-abdominal infections, complicated skin and soft-tissue infections&nbsp

Samar Genedy,1 Ahmed Khames,2,3 Amal Hussein,4 Hatem Sarhan4 1Department of Clinical Pharmacy, Faculty of Pharmacy, Minia University, Minia, Egypt; 2Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt; 3Department of Pharmaceutics and Pharmacy Technology, College of Pharmacy, Taif University, Taif, Kingdom of Saudi Arabia; 4Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Minia University, Minia, Egypt Background: Hypertensive disorders are the most common complication in pregnancy which can even lead to maternal mortality. Hydralazine hydrochloride (HHC), a direct-acting vasodilator, is intravenously used as the first-line therapy in controlling hypertension in pregnancy (preeclampsia). It suffers poor oral bioavailability (26%–50%) due to first-pass metabolism.Objective: This work aims for the preparation of HHC rapidly disintegrating sublingual tablets of higher absorption rate, short onset of action, and higher bioavailability for rapid control on blood pressure (BP) in hypertensive emergencies especially preeclampsia.Methods: HHC sublingual tablet mixtures were prepared using starch sodium glycolate and Pharmaburst as super disintegrants at three different levels by direct compression and were subjected to full in vitro evaluation; the drug bioavailability from the optimized sublingual tablet formula was assessed in comparison to conventional oral tablets in rabbits, and the clinical efficacy on controlling BP in induced preeclampsia like mouse model was also studied.Results: The results indicated compatibility of the prepared tablet mixtures, good flow, and acceptable mechanical strength. Sublingual tablet formula containing Pharmaburst (7%) that showed fastest disintegration (21 seconds) and 100% drug release within 5 minutes was selected for further bioavailability and pharmacodynamic studies. The drug bioavailability was significantly increased with Cmax = 28.2767±4.61 µg/mL, AUC(0–α) = 52.85±3.18 µg.h/mL, and Tmax = 0.33±0.011 hour in comparison to 18.0633±23.2 µg/mL, 33.18±5.18 µg.h/mL, and 0.75±0.025 hour for conventional oral tablets. Results of pharmacodynamic studies proved significant rapid control on both systolic and diastolic BP to normal values within only 30 minutes without any significant difference from intravenous data.Conclusion: These results confirm the suitability of the prepared HHC sublingual tablets for use in rapid control on hypertensive crisis especially in pregnant women as an alternate to parenteral administration.Keywords: pre-eclampsia like mouse model, absorption from buccal cavity, preeclampsia, sublingual tablets, hypertension, L-NAME

Acne vulgaris is a common inflammatory skin disorder. It affects the pilosebaceous units followed by an overgrowth by Propionibacterium acne bacteria. Dapsone is a sulfone antibiotic with an anti-inflammatory effect, which is considered to be accountable for its effectiveness in the treatment of acne vulgaris. The present study aims to prepare and evaluate the effectiveness of dapsone niosomes for topical application with an objective to control and prolong the release of the drug with improved skin penetration as a novel formulation for healing of mild to moderate acne vulgaris. Niosomes were formulated by thin film hydration method using different ratios of surfactants (various spans 20, 40, 60 and 80) and cholesterol and were investigated with respect to its shape, size, entrapment efficiency, Fourier transform infrared spectroscopy (FTIR) and in vitro release. Fifteen patients with mild to moderate acne vulgaris were selected and treated with dapsone niosomes as a single topical treatment for their acne lesions. Clinical assessment was done before and after 2 and 8 weeks of treatment. Niosomes containing span 60 showed a higher percentage of drug release after 24 h and greater entrapment efficiency as compared to other formulations. The clinical improvement was noticeable after 2 weeks of treatment with highly significant improvement of acne lesions after 8 weeks of treatment (P < 0.001). Dapsone niosomes is a promising topical formulation for safe, tolerable and effective drug delivery system with minimal side effects apart from mild erythema and post-inflammatory hyperpigmentation. Key words: Dapsone, acne vulgaris, niosomes, topical, clinical application.

Liquorice is one of the commonly used herbs in the field of medicine due to its pharmacological activities. Among these activities, the anti-inflammatory and antiallergic activities that support its use in asthma. This study included 80 asthmatic patients who were classified into two groups, group 1(Placebo group) maintained on inhaled corticosteroids (ICs in moderate to high doses) and long-acting beta agonist (LABA) and received starch capsule (500mg starch) twice daily as placebo and group 2 (active treatment group) maintained on ICs (in moderate to high doses) and LABA and received liquorice extract capsule (500mg equivalent to 100mg glycyrrhizin) taken twice daily. The efficacy of liquorice was measured by estimation of pulmonary function and blood eosinophils %. On the other hand, safety was assessed by blood pressure measurement and determination of serum potassium level. The results revealed that addition of liquorice capsules to ICs and LABA resulted in a non-significant improvement in blood eosinophils (P-value 0.754). However, it resulted in a highly significant improvement in Forced Vital Capacity (FVC) % and Forced Expiratory Volume1 (FEV1) % when compared to group 1 (P-value 0.031.and 0.040 respectively). Regarding liquorice safety, neither Blood pressure (systolic and Diastolic) (SBP and DBP), nor serum K level showed any significant change in patients received liquorice capsules. Conclusion: liquorice in the used dose significantly improved FVC% and FEV1% but did not affect blood eosinophils. There was no significant effect on blood pressure and serum K level, so, this dose is safe with no observed side effects.

Mohamed M Ibrahim,1 Tarek Fouad Tammam,2 Mohy El Deen Ebaed,3 Hatem A Sarhan,4 Gamal F Gad,5 Amal K Hussein4 1Department of Clinical Pharmacy, Faculty of Pharmacy, Minia University, Minia, Egypt; 2Department of Anesthesia and Intensive Care, Faculty of Medicine, Suez Canal University, Ismailia, Egypt; 3Department of Biochemistry, Egyptian Ministry of Interior, Cairo, Egypt; 4Department of Pharmaceutics, 5Department of Microbiology and Immunology, Faculty of Pharmacy, Minia University, Minia, Egypt Background: Mechanical ventilation support can be the main source of ventilator-associated pneumonia (VAP). VAP is a serious infection that may be associated with dangerous gram-negative bacteria mainly, and it leads to an increase in the mortality in the intensive care unit (ICU). Imipenem is one of the strongest antibiotics now available for treating VAP which is associated with gram-negative and gram-positive bacteria, and it belongs to beta-lactam antibiotic group (carbapenem).Objective: This study tried to investigate the efficacy of imipenem against VAP when it was infused within 180 min versus the efficacy when it was infused within 30–60 min.Setting: This study was conducted in main ICU in general hospital which consists of surgical and medical beds within 2years. One hundred and eighty-seven patients were enrolled on it.Method: This study is a retrospective cohort which was conducted within 2 years. The efficacy of imipenem which was administered by intermittent infusion (30–60 min) within first year was compared with the efficacy of imipenem which was administered by extended infusion (180min) within second year in the field of VAP curing and cost reduction. All data were collected retrospectively from patient medical files and were statistically analyzed by SPSS version 20.Main outcome: The study was designed to measure clinical and cost reduction outcomes, mortality and hospital stay.Results: The results indicated that there is a significant decrease in mortality, number of recurrent infection, and ICU stay length, and the number of mechanical ventilator days was associated with extended imipenem infusion during the second year of the study.Conclusion: The use of imipenem with extended infusion over 3 hours enhances its clinical outcomes in the treatment of VAP. Keywords: carbapenem, imipenem, VAP, extended infusion, intermittent infusion

Chronic infection with HCV is a worldwide health problem that may lead to cirrhosis, portal hypertension, hepatocellular failure and hepatocellular carcinoma in most of cases. A new era in HCV treatment has been started using direct acting antiviral activity. In this study we assess the safety and efficacy of a combination therapy Sofosbuvir/Simprevir in the treatment of chronic HCV patients genotype IV either cirrhotic or non-cirrhotic. In the outpatient clinic, one hundred and seventy five chronic HCV patients were recruited from Tropical Medicine Department at Fayoum public hospital. A combination of Sofosbuvir (400 mg) and Simeprevir (150 mg) was administered for those patients once daily over a period of 12 weeks. All patients have been followed up for clinical and laboratory parameters and HCV PCR to evaluate the efficacy and safety of this therapy. Sustained Virologic Response rate (SVR12) were 97.7% (169/173) (primary end point), and same results obtained at the second end point (SVR 24). In this study, cirrhotic patients showed lower SVR (92.7%) compared to non-cirrhotic patients (98.5%) (p-value 0.085). Majority of patients (57.14%) reported adverse events (AEs) during treatment and most common AEs were headache, fatigue, pruritus, dizziness and photosensitivity. On the basis of the evidence currently available, it seems fair to suggest that the combination therapy of (SMV/SOF) in the treatment of chronic HCV genotype IV naïve and experienced patient whether cirrhotic or non-cirrhotic is safe and effective. This was evidenced by monitoring patients clinically and using hepatic parameters after drug administration. The adverse events affected patients were mild and tolerable among patients. [Med-Science 2018; 7(1.000): 122-126]

This study aimed at combining the hen's egg test-chorioallantoic membrane (HET-CAM), bovine corneal opacity and permeability (BCOP) test and histological examination of excised corneas to evaluate the conjunctival and corneal toxicity of niosomes and their ingredients. Various surfactant/lipid combinations and concentrations (1-10%, w/v) were investigated for the ocular delivery of an ambitious drug (naltrexone hydrochloride) for treatment of diabetic keratopathy. Four niosomal formulations were investigated and found to be non irritant to the 10 days old HET-CAMs (an acceptable conjunctival model). Only one of the tested ingredients (sodium cholate - CH) showed moderate irritation, however such an effect was diminished when incorporated into niosomes. Corneal opacity and fluorescein permeability scores for the test substances correlated well with the HET-CAM test results. Corneal erosion and stromal thickness were found to be in agreement with the HET-CAM and BCOP results, which discriminated well between moderately and mildly irritant test substances. Corneal histological examination revealed toxicity signs included epithelial erosion, stromal condensation and stromal vacuolisation, which allowed better discrimination between strong and moderate irritants. It is concluded that the prepared niosomes possess good ocular tolerability and minimal ocular tissue irritation. They can be further investigated as ocular delivery systems using appropriate animal models.