Volume 8 - Issue 4

S.No Title & Authors Name Page
Environmental Monitoring and Risk Assessment of Cleanrooms within Pharmaceutical Industry
Azam Mehdi, Muhammad Danish Mehmood*, Muhammad Usman Ghani, Muhammad Ismail, Faisal Ameen, Saud-ul-Hassan
 Abstract                  View                 Download                 XML

Environmental monitoring is a scrutinizing program for microbial and particulate contamination of clean rooms and associated clean zones for aseptic processing. The current study was therefore, designed to evaluate the quality of clean rooms environment of local vaccine manufacturing unit in compliance with the international cleanroom standards proposed by the World Health Organization (WHO) for the production of quality biological products. The classified areas were divided into 60 gridlines where 30 sampling sites were randomly identified in which 20 critical and 10 non-critical sites were allocated and 700 liters/m3 air was aspirated through air sampler. Furthermore, particles size of 0.5 um and 5.0 um were also detected for 1 minute from all critical and non-critical sites. It was revealed that viable count obtained from sampling sites designated as class A of Production Section I and II was less than ≤ 1 CFU/m3 . Whereas, the number of non-viable particles having size of ≤ 0.5 μm in class A at rest were ≤ 3,520 CFU/m3 as compare to 20/m3 of particle size ≥ 0.5 from each sampling sites in both the sections. Moreover, Finger DAB testing confirmed the hygienic status of personnel and proper use of antiseptics and sterile garments (˂1 CFU/gloves). Manometer readings in three airlocks in production section were recorded as 0.05, 0.10 and 0.15 inch of water gauge respectively. Consequently, it is concluded that all sections of vaccine manufacturing unit are comply with WHO cleanroom standards. In each sampling site of all clean zones shows viable and non-viable counts within the limits set by local authorities and international cleanroom standards.

Evaluation of Anti-Diarrheal and Central Nervous System Depressant Effect of Flacourtia indica in Swiss Albino Mice
Md Al Foyjul Islam, A M Rakibur Rahman, Md Abdullah Al Sadi Khan, Arjyabrata Sarker, Md Jahir Alam, M S K Choudhuri, Runa Masuma*
 Abstract                  View                 Download                 XML

Flacourtia indica (FI) has been used in traditional system of medicines to treat several diseases like snakebite, cancer, diabetes and hepatic disorders. This study evaluated the anti-diarrheal and central nervous system (CNS) effect of ethanolic extract of FI in mice. Anti-diarrheal activity was evaluated using castor oil and MgSO4 induced diarrhea tests in mice. GI motility was estimated using BaSO4 milk. CNS effect was investigated using hole board, hole cross and elevated plus maze test. Extract was used at doses of 500 mg and 1000 mg/kg body weight. Loperamide (10 mg/kg p.o) and diazepam (4 mg/kg) were used as standard drug. The FI extract showed statistically significant anti-diarrheal effect in the total number of feces and episodes of diarrheal feces. Treatment with FI at both doses reduced diarrhea very highly significantly (p<0.001) in castor oil and highly significantly (p<0.01) in MgSO4 induced diarrhea test. FI at 500 mg/kg and 1000 mg/kg doses caused a reduction in the diarrheal stools by 70% and 77.50% in castor oil induced diarrhea. In MgSO4 induced diarrhea, the plant extract lowered diarrhea by 39.54% (p<0.05) and 48.84% (p<0.01) respectively. FI reduced GI motility very highly significantly (p<0.001) at both the doses after 30 minutes of BaSO4 administration. Standard drug loperamide (10 mg/kg) had very highly significant (p<0.001) antidiarrheal effect. The extract resulted significant CNS depressant effect (p<0.001) in hole board, hole cross and elevated plus maze test. The overall results depicted that the FI extract had significant antidiarrheal and CNS depressant properties.

Preventing Inappropriate Hydroxyurea Dosing in Children by Introducing a Child-Appropriate Preparation
Gideon Koren*, Michael Lishner, Ami Ballin
 Abstract                  View                 Download                 XML

Hydroxyurea (HU) is the only FDA- approved disease- modifying drug for sickle cell disease, by inducing the production of fetal hemoglobin and thus decreasing the sickling of red blood cells. Till recently HU was available only in adult doses of 1000 mg. This meant that to aim at the standard dose of 20 mg/kg/d, most young children had to be overdosed, or the doses had to be fluctuated daily to achieve the aimed mean dose. Because adherence improves with unchanged daily dose, and due to the more than 10 fold variability in HU pharmacokinetics in children, there was an urgent need for a pediatric formulation of HU.
This issue has been solved with FDA approval of the French-originated orphan HU, Siklos, a preparation of 50 and 100 mg, which prevents the risk of inappropriate dosing in children.

Medicine Containing Herbs and Vitamins Have Eliminated 100% of Hepatitis B Virus, Prevent the Progression of Cirrhosis and Liver Cancer
Nguyen Thi Trieu*
 Abstract                  View                 Download                 XML

Immunodeficiency and viral hepatitis rate are increasing. Currently, there are a lot of treatment plans for hepatitis B in the world. However, make preparations still have limited in effectiveness, lead to high rate of cirrhosis and liver cancer worldwide, the currently available medicines cannot fully deliver their effectiveness is because they do not create a favorable environment with the presence of intermediates needed for the body to produce antibodies against the virus, not support of the NRTIs (nucleoside reverse transcriptase inhibitors); To overcome these weaknesses, the invention of the herbs and vitamins mixture have made a new breakthrough, created a “perfect cell type” with the ability of preventing the invasion of virus and destroy the “mini-chromosome” of hepatitis B virus, it has helped to improve the treatment’s effectiveness. The medicine contains the following components: Adenosma Glutinosum; Eclipta Prostrata; Phyllanthus Urinaria; Ascorbic acid; Cyanocobalamin.
Post-treatment criteria:
Virus level (HBV-DNA test): see in the blood contains complete virus (including the core and shell).
Monitoring the outcome of treatment to test for HBsAg Cobas level in HBsAg Cobas (+) patient and achieved a score of < 1 (unit: COI, standard index <1). There is a small percentage of the patient showed HBsAg Cobas (-) after 24 months. Stop the treatment after achieving these criteria. The medicine has increased the therapeutic efficacy in patients with cirrhosis and liver cancer, applicable in patients with primary liver cancer and currently used alongside with Radiofrequency Ablation or Transarterial Oily Chemo Embolization.

Ethnobotanical, Phytochemical and Pharmacological Aspects of Genus Alysicarpus
Maryam Bashir*, Muhammad Uzair, Bashir Ahm
 Abstract                  View                 Download                 XML

Plant species and their active constituents play an important role in the prevention of a variety of ailments. The genus Alysicarpus comprises of about 30 species, out of which, eight species are found in Pakistan. Only a few species of the genus Alysicarpus have been investigated for phytochemical and biological activities. A variety of potentially bioactive molecules such as alkaloids, flavonoids, phenolics, terpenoids and steroids have been isolated from various species of genus Alysicarpus. It has been reported that these species possess analgesic, anti-inflammatory, antimicrobial, antiplasmodial, larvicidal, mosquitocidal, antioxidant, hepatoprotective, antiproliferative and antifertility activity. This article aims to highlight the ethnomedicinal uses, phytochemical and pharmacological aspects of Alysicarpus species and illustrates the potential of the genus as a source of therapeutic agents.