American Journal Of Pharmacy And Health Research

ISSN NO.: 2321-3647
January 2016 Issue 1

Pharmaceutical “Good Transportation Practices (GTP)”- An Innovative Concept In ‘GXP’ Acronym

Nirmal Kumar*1, Ajeya Jha1

1.Sikkim Manipal Institute of Technology, Majitar, Rangpo, Sikkim -737132, India


There are several approaches of quality system, which adequately take care of pharmaceutical manufacturing and distribution operations. In addition to conventional perspectives there is a need of specialized quality system during transportation and shipment of pharmaceutical products. An exploratory study on transportation quality system shows that as such there is no system with nomenclature ‘Good Transportation Practices’. The quality system during transportation is apparently a forbidden concept, although other pharmaceutical quality systems based on GXP nomenclature are available, such as Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP) etc. Pharmaceutical Good Transportation Practices (GTP) is a novel approach to summarize the elements of quality systems during transit and shipment. The new GTP philosophy is based on core quality system elements like training, documentation, validations, qualification etc. This study on Good Transportation Practices proposes a new concept in pharmaceutical industry, which shall act in alliance with manufacturing and distribution operations to further strengthen the pharmaceutical quality system.

Keywords: GXP, GDP, Pharmaceutical Transportation, Temperature Excursions


Milk Thistle-An Overview

Mohana M Nair1*, Neethu Mohan1, Jiju V1

1.Nazareth College of Pharmacy, Othera, Thiruvalla,Pathanamthitta, Kerala


Milk thistle (Silybum marianum, family-Compositae) is widespread throughout the world. Milk thistle's common name comes from the white markings on the leaves and its milky white sap used traditionally by nursing mothers to increase milk. Milk thistle appears to be safe and have multiple health benefits on various liver conditions viz; liver cirrhosis, alcoholic hepatitis, alcoholic fatty liver, liver poisoning, and viral hepatitis. Primary chemical constituents of Milk Thistle include flavolignans (silymarin), tyramine, histamine, gamma linoleic acid, essential oil, mucilage, and bitter principle. Available evidence is not sufficient to suggest whether milk thistle may be more effective for some liver diseases than others or if effectiveness might be related to duration of therapy or chronicity and severity of liver disease.

Keywords: Milk Thistle, Liver diseases, Liver poisoning, Silymarin, Tyramine, Histamine


Management of Polycystic Ovarian Syndrome (Keesa-e-Khusyatur Rehm): Unani Perspective

Salma Mirza1*, S.A.Naaz2, S.M.Alim3

1.JTD, Deoband, District Saharanpur, India.

2.Deptt. Amraz-e-Niswan wa Atfal, AKTC, AMU, Aligarh, India

3.Unani Medical Officer, Bharatpur Govt. Of Rajasthan, India


The polycystic ovarian syndrome (PCOS) is the most common endocrine disorder that affects between 10-15% of women during their reproductive age. Its prevalence is 6.5% to 8%, using biochemical and/or clinical evidence, and ultrasound-based studies have reported a prevalence of 20% or more. Anovulation is hallmark of PCOS which is the leading cause of infertility in this syndrome with a prevalence of 68%. PCOS is a heterogeneous disorder. It was originally described by Stein and Leventhal in 1935 as a clinical triad of hyperandrogenism, anovulation and obesity in women with enlarged polycystic ovaries. Women with PCOS are at increased risk of reproductive problems including infertility, endometrial cancer, late menopause and also metabolic aberrations including insulin resistance, type 2 diabetes mellitus, dyslipidemia and cardiovascular diseases. In Unani System of medicine, the disease has not been defined under the term of PCOS; as disease has been categorized recently just a century before. The description of the disease has been described vividly by various Unani physicians under the headings of ehtebase tams and uqr According to Hippocrates the main cause of the disease is impairment of humors (Akhlat).  PCOS cater to different symptoms, effective treatment to manage PCOS is a challenge.The best known treatment of PCOS at present is by using allopathic medicines such as clomiphene citrate, metformin, tamoxifene and troglitazone. All these drugs have mild to severe side effects including hot flushes, arthritis, joint or muscle pain and psychological side effects such as irritability, mood swings, depression and bloating. So there is a need for developing a regimen to offer cheap and best treatment for this disease.Unani system of medicine is the oldest system that prevails till dates with its effective remedies derived from plants, animals and mineral sources. There are various single and compound drugs to cure different disorders of the human body. The causes of infertility in female due to obesity and PCOS as described by modern medicine are very much similar to the causes and features of uqr in  Unani medicine, but the cellular and hormonal concept in relation to this disorder is recent. The drugs which correct ehtebase tams, uqr and sue mizaj barid are generally found to be useful   in PCOS, but their efficacy has not been validated scientifically

Keywords: Unani Medicine; PCOS; Keesa-e-Khusyatur Rehm


Calcium Alginates Microbeads for Oral Delivery of Clonidine Hydrochloride

Daya Lodhi1, Eisha Ganju1, Neeraj Upamanyu1, Vinod Dhote2 and Subhendu Mishra3

1.School of Pharmacy and Research Center, People’s University, Bhopal (MP).

2.Truba Institute of Pharmacy, Bhopal (MP)

3. Ravishankar College of Pharmacy, Bhopal (MP) 


In present work calcium alginate (CA) microbeads encapsulated clonidine hydrochloride was prepared by ionotropic external gelation method in which calcium chloride used as cross-linking agent. Clonidine hydrochloride is a sympatholytic centrally acting α2 adrenergic agonist and imidazoline receptor agonist used to treat high blood pressure, attention deficit hyperactivity disorder, anxiety disorders, migraine, and menopausal flushing but it have very short half life which required some new approach which help to retain it in the body for longer period of time. Calcium alginate microbeads represent a useful tool for oral sustained/ controlled drug delivery. The prepared alginate beads were studied for percent loading efficiency, average particles size, shape and surface morphology, Differential Scanning calorimeter (DSC) and drug release behavior. Chitosan and HPMC incorporated in addition to overcome rapid drug release at higher pH due to its high porosity. Prepared optimized alginate microbeads formulation found to be 356.22±8.1nm average in size, 86.46±2.6% entrapment efficiency. DSC and FT-IR confirm no interaction with the polymers used in the formulation. High concentration of polymer and CaCl2 increase the drug loading efficiency while high concentration of CaCl2  also retard the release of clonidine hydrochloride from the beads. The shape and surface morphology was determined by scanning electron microscopy (SEM) and found the beads in smooth and spherical in shape. In-vitro release study showed that microbeads release 97.85 % drug in 7 hr which was pH dependent and also due to swelling and surface erosion. Microbead release the drug which follow Higuchi matrix diffusion release kinetic. Finally it is concluded that alginate, HPMC and chitosan in combination can be used to prepare microbead to encapsulate clonidine hydrochloride in higher amount. Biodegradable and non toxic nature of polymer make the prepared microbeads suitable for oral administration. 

Keywords: Microbeads, alginates, chitosan, HPMC, sustained release.


In Vitro Cytotoxicity Evaluation of Troglitazone, Rosiglitazone and Pioglitazone in HepG2 Cells

Pavankumar M Sancheti 1*, Sunil P Pawar2

1. Glenmark Research Centre, Navi Mumbai, Maharashtra, India

2.P.S.G.V.P. Mandal’s College of Pharmacy, Shahada, Maharashtra, India


The objective of this research work was comparative evaluation of in vitro cytotoxicity of troglitazone, rosiglitazone and pioglitazone in HepG2 cells. Briefly, the HepG2 cells were exposed to multiple concentrations (3.125–100 µM) of three drugs (troglitazone, rosiglitazone and pioglitazone) for 12 h, 24 h and 48 h. At the end of each treatment period, cytotoxicity was determined using multiple end points such as 3-[4,5-imethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) assay, neutral red assay and lactate dehydrogenase leakage assay. Troglitazone showed time and concentration dependent cytotoxicity in all three end points with evident cytotoxic effects being observed at 50 and 100 µM concentrations. MTT assay showed higher cytotoxicity and early onset compared to neutral red and lactate dehydrogenase leakage assay at all time points. There was no cytotoxicity observed for rosiglitazone at all tested concentrations up to 100 µM. Similarly, pioglitazone also did not affect the viability of HepG2 cells up to the concentration of 50 µM however some cytotoxicity was noted at 100 µM concentration which could be partly attributed to the precipitation of test compound noted at 100 µM concentration after addition to the culture medium. The results from this research work indicated that among the three drugs tested in this study, only troglitazone induced time and concentration dependent toxicity in the HepG2 cells in all three end points with MTT assay being the most sensitive assay.

Keywords: Troglitazone, Rosiglitazone, Pioglitazone, HepG2, Cytotoxicity


Formulation and Evaluation of Ophthalmic Preparations Containing Econazole Nitrate-Cyclodextrin Complexes

Abd El-Gawad H. Abd El-Gawad1*, Osama A. Soliman1, Marwa S. El-Dahan1, Saeed A. S. Al-Zuhairy1

1.Department of Pharmaceutics, Faculty of Pharmacy, Mansoura University, 35516, Mansoura, Egypt


Improvement of ocular delivery systems properties remains a major challenge to achieve a continued therapeutic effect of drugs. The aim of the present study was to improve the solubility, dissolution rate and hence the ocular bioavailability of econazole nitrate (EC). To achieve this goal, econazole nitrate was complexed with β-cyclodextrin (β-CyD) and hydroxypropyl-β-cyclodextrin (HP-β-CyD) using co-precipitation method. The influence of different CyDs on EC complexation was investigated by different methods as fourier transform infrared spectroscopy (FT-IR), differential scanning calorimetry (DSC) and powder X-ray diffraction (PXRD). The present work includes the preparation of eye gels and ocuserts containing econazole nitrate-cyclodextrins complexes using different polymers. Physicochemical properties (pH, viscosity, uniformity of drug content, in-vitro release) of the preparations were studied by the appropriate methods. The obtained results revealed that, EC solubility increased as a function of CyDs concentration. All formulations possessed uniform drug content with pH and viscosity compatible with the eye. In-vitro release data of ophthalmic formulations showed a sustained release with the diffusion-controlled mechanism (Higuchi model). Ocular bioavailability of EC-CyD complexes from the selected formulations was significantly (p<0.05) improved compared to that of the drug alone. Collectively, the improvement of the solubility, dissolution rate and ocular bioavailability of EC was more pronounced with HP-β-CyD.

Keywords: Econazole nitrate; cyclodextrins; complexation; ophthalmic preparations; ocular bioavailability.


Study of Cardiovascular Complications In Chronic Obstructive Pulmonary Disease With Reference to ECG And 2D Echocardiography Findings

G.Chandra Sekhar1*, P.Sammaiah1, Kishan Bookya2, Bairam Balaji1

1.Department of General Medicine,KMC,MGMH, Warangal,Telangana, India.

2.Department of Pathology, ACSR Govt medical College, Nellore, Andhra Pradesh, India.


To study the electrocardiography and echocardiography findings in COPD patients and to correlate these findings with duration and severity of the disease and compare the results of clinical, ECG and echocardiographic evidence of RV dysfunction. Patients were selected over one year and studied with a detailed history including symptoms, duration of smoking and physical examination. They were investigated with spirometry, ECG and echocardiography. Patients were graded into Mild, Moderate, Severe and Very Severe categories according to GOLD criteria. Statistical analysis of association was done with Chi-square test and statistical significance were taken as p < 0.05.Mean age was 59.9±10.4 years with male predominance. Mean duration of disease was 5.71 years. Patients had a mean duration of smoking of 23.2 ±3.6 pack years. ECG findings showed significant correlation with severity were low voltage complexes and incomplete RBBB and ECHO findings showed significant correlation with RVH, RVF, Pulmonary Hypertension and Cor pulmonale. Diagnosis of the cor-pulmonale clinically was 36%, ECG 56%, echocardiographically 60%. COPD is more common in males in 5th to 7th decade in  the smoking history of more than 20 pack years. Most patients have advanced disease at presentation. The incidence of the ECG and Echo findings increase as the severity and duration of the disease increases and echocardiography is better than ECG or clinical methods in detecting RV dysfunction.

Keywords: COPD, ECG, Echocardiography, Cor-pulmonale, smoking history


Evaluation of Phytochemical Screening and Anti-Inflammatory Activity of Root Extracts of Solanum Sisymbriifolium Lam

Mayuri Thumar 1*, Rachana Katbamna1

1. B. K. Mody Government Pharmacy College, Rajkot, Gujarat, India.


Nonsteroidal anti-inflammatory (NSAIDs) drugs are generally used as a part of drug therapy in inflammation. However, these drugs have severe side-effects. Therefore, naturally originated compounds with very little side-effects are required to substitute chemical therapeutics and have better safety profile. Solanum sisymbriifolium (Family: Solanaceae) has many therapeutic uses mentioned in Ayurveda. Moreover, the plant has diverse pharmacological activity such as antihypertensive, diuretic, analgesic, contraceptive, antisyphilitic, hepatoprotective. Therefore, the present study was designed to investigate the preliminary phytochemical screening and anti-inflammatory activity of methanolic extract of roots of Solanum sisymbriifolium (MERS). Carrageenan-induced rat paw edema model was used for assessing the anti-inflammatory activity. The phytochemical analysis of MERS confirmed the presence of alkaloids, carbohydrates, flavanoids, terpenoids, tannins and saponins. Furthermore, MERS at doses of 50,100, 200 and 300 mg/kg showed anti-inflammatory activity in dose-dependent manner.  

Keywords: Anti-inflammatory activity, Aspirin, Carrageenan-induced paw edema, root methanolic extract, Solanum sisymbriifolium



Infant Mortality in Developing Countries: Comprehensive Review

Muhammad Bilal Hassan Mahboob1, Muhammad Jamshaid1, Irfan bashir1, Tehseen Riaz1, Tooba Mehboob1, Zartasha Safdar2

1.Faculty of Pharmacy, University of Central Punjab Lahore, Pakistan.

2. Government College University, Lahore Pakistan.


The death of children before completing one year is called as infant mortality which is measured by IMR (infant mortality rate) that is the number of children death before completing one year of life per thousand live births. Knowledge about this infant mortality is were important as the number of infants deaths are increasing day by day. Asphyxia, pneumonia diarrhea, malnutrition and preterm complications are some of the leading causes of infant mortrality. Environmental factors, parental education, santation problems should be given some extra care for the prevention of infant mortality. Infant mortality is one of the important index of measuring the development of a country or a region. Further robusting, dynamic and healthy research is suggested in order to recognize loop holes regarding infant mortality globally specially in developing countries to decrease infant mortality rate to lowest level. By throwing light on this topic arranging workshops and awareness programs, infant mortality rate can be reduced

Keywords: Infant mortality rate, Healthy research