Volume 8 - Issue 1

S.NO Title & Authors Name page
Evaluation of Novel Ion Sensitive In situ Gelling Polymer in the Development of Ophthalmic Drug Delivery System
Atish S Mundada
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The attempt has been made in the present work to formulate an ion sensitive in situ gel of an antibacterial agent, Ciprofloxacin HCl nemploying a novel in situ gelling low methoxy pectin (obtained from the heads of Helianthus annuus Linn) as bioadhesive polymer. The drug loaded in situ gelling formulation was developed employing the cold method. The prepared formulations were evaluated for appearance, clarity, pH, gelling capacity, viscosity, drug content, mucoadhesive force, gelling strength, in vitro drug release,isotonicity study, sterility test and stability study. The results of various physicochemical evaluation shows that the formulation comprising of 2.5% w/v low methoxy pectin to be considered as an optimized in terms of gelling capacity, viscosity, gelling strength, the drug release study giving sustained release behavior over period of 11 h. Thus we claim that ion sensitive in situ gel of Ciprofloxacin HCl was successfully formulated using low methoxy pectin obtained from heads of Helianthus annuus L as a natural ion sensitive, bioadhesive polymer. Thus, it can be concluded that formulation containing low methoxy pectin (2.5% w/v) showed better potential for sustained topical ocular delivery as supported by ex- vivo test studies.
Cubosomes - A Novel Drug Delivery System
Ancy Thomas
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Cubosomes are discrete, sub-micron, nanostructured particles of the biscontinuous cubic liquid crystalline phase. It consists of honeycombed structures separating two internal aqueous channels and a large interfacial area. Cubosomes are composed of polymers, lipids and surfactants with polar and non-polar components hence said as amphiphilic. Thus cubosomes are bicontinuous cubic liquid phase enclosing two separate regions of water divided by surfactant controlled bilayers and hence the prodrugs and cyclodextrins can be incorporated into it among others. Cubic liquid crystals are physically transparent and isotropic phases that are stable in excess water and show a unique system for the production of pharmaceutical dosage forms. The structure of cubosomes generally maintains the efficacy; stability of actives such as vitamins and proteins. Cubosomes are thermodynamically stable; lasting indefinitely. Colloidal dispersions of cubosomes can be stabilized by the addition of polymers. Improved stability of drug in formulation, desired particle size range, maximum drug loading capacity and well controlled drug release made cubosomal systems superior to other novel delivery systems like solid lipid nanoparticles, microemulsions, microspheres and liposome. The choice of technique depends on the nature of polymer as well as the nature of drug and the duration of therapy. The most important physico chemical factors that may be controlled in cubosome manufacture are also being considered. The cubosomes offer well controlled delivery to variety of drug candidates like anti-inflammatory compounds, local anesthetics, antibiotics and anticancer drugs and the lipid entrapped cubosomal vaccines. The controlled release application of these nanoparticles is of a great significance in cosmeceutical and pharmaceutical fields.
A Brief Review on: Hazelnuts
Kiran Dobhal
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Different types of nuts like almonds, Brazil nuts, hazelnuts, peanuts, pine nuts, walnuts and cashews are present all over the world. Hazelnut is the nut of the hazel deriving from species of the genus Corylus, especially the nuts of the species Corylus avellana. It is the second most expensive nut and needs cold and hilly terrain with a few days of sub-zero temperature. Therefore, Himachal Pradesh and Jammu and Kashmir, Silguri, Uttarakhand & North-East states make the best choice in India. It takes three to five years for hazelnut plants to grow and yield fruit. Hazelnuts are rich in monounsaturated fatty acids, antioxidant bioactive substances & rich source of oleic acid (about 80%), which decreased risk of cardiovascular disease. It is used as antioxidant, hypocholesterolemic, cardioprotective, anticancer, anti-inflammatory & in production of biodiesel. Turkey is the biggest market of the hazel nut in the world. The present article provides an overview about the significant of hazelnut.
Probiotics, Zinc Re-Inforced Dextrin Compensated Reduced Glucose Hypo-Osmolar Oral Rehydration Salts
D. H. Pathirana
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Use of standard Oral Rehydration Salts in diarrheal diseases has been limited by its inability to reduce severity or duration of diarrhea. Proposed formula has dextrin replacing 70% glucose, a reduced osmolarity (206 mosmol/L), with zinc and probiotics, the last three being therapeutically effective. Starch in rice grains of Madathawalu species was partially hydrolyzed to dextrin at 1300C for 3.5 hours. Comparative glucose release studies with rice flour and dextrinized rice flour and electrolyte contents were determined where Na+, K+ and Zn2+ was found distributed within ± 4% of the target British Pharmacopeia specifications. The product was stable for three months with no effect to flow properties of the powder and color.
Analytical Methods of Six FDA Approved Molecular Entities Used for the Treatment of Non-Small Cell Lung Cancer: A Concise Review
Mohammad Shahriar
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Analytical method development and validation are continuous inter-dependent tasks associated with research and development, quality control and quality assurance departments as they help to understand the critical process parameters and to minimize their influence on accuracy and precision. Standard and analytical procedures of anticancer drug may not be available in pharmacopeias. The time and effort that are put into developing scientifically sound, robust, and transferrable analytic methods should be aligned with the drug development stage. Therefore it becomes necessary to develop and validate new analytical methods for such drugs. In this review the methods for the analysis of such recently approved new molecular entities in various matrices are presented. This review helps in understanding the further need for the development of analytical methods for the estimation of such drugs.
Role of Prior Rituximab on Outcomes of Asct in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Systematic Review and Meta-Analysis
Li Li
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The aim of this study was to investigate the impact of prior rituximab on the subsequent results of autologous stem cell transplantation (ASCT) for relapsed or primary refractory diffuse large B-cell lymphoma (DLBCL). The random-effect model was used with the relative risk (RR) as the measure indicator. Patients were divided into two groups according to whether rituximab was administered (R group) or not (No-R group) prior to ASCT. The meta-analyzed RR and 95% confidence interval in the R group versus the No-R group were: 0.83 (0.69,0.99), 0.84 (0.72,0.98), 0.94 (0.71,1.25) for two-, three-, five-year overall survival (OS); 0.91 (0.77,1.08), 0.85 (0.69,1.06), 0.85 (0.62,1.17) for two-, three-, and five-year progress free survival (PFS); 0.46 (0.27,0.80), 0.47 (0.29,0.76), 0.74 (0.15,3.52) for two-, three-, and five-year event free survival (EFS). The results show the treatment trend of pre-treating with first-line rituximab-containing therapy for relapsed or refractory DLBCL is more favorable than with ASCT-naive.
Does Epstein - Barr Virus Cross Talks with Sex Hormone Receptors on Lymphoid Cells Differently to Produce Lymphoma?
Ahed J Alkhatib
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It has been recently reported that the idea of cross-talks between hormone receptors including estrogen receptor (ER) and progesterone receptor (PR) in breast cancer to have significant impacts on breast cancer. The interactions of Epstein - Barr virus (EBV) and lymphoma have been previously demonstrated by many studies including ours. In this study, we aimed to examine the hypothesis that “EBV crosstalk with sex hormones plays a role in directing the type of lymphoma, Hodgkin’s Lymphoma (HL) or non –Hodgkin’s Lymphoma (NHL)”. We studied the expression of sex hormones, ER, and PR in addition to EBV in lymphoma cases representing HL and NHL. Immunoperoxidase staining was used to assess the expression of these biomarkers in lymphoma cases. The findings of our study showed that EBV cross talks with ER significantly associated with HL (p<0.05), while its talk with PR was significantly associated with NHL (p<0.05). Conclusions: The results of the present study showed that EBV may work as the maestro of an orchestra and leads the events of lymphoma through different crosstalk with sex hormones. This may open the door for new therapeutic options for lymphoma.
Concepts for Alzheimer’s Disease Drug Development
Prayuth Poowaruttanawiwit
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Alzheimer’s disease (AD) was a neuronal disease with no completely cure drug [1,2]. Patient with AD suffer from symptoms which required closely attention [2-5]. The important limitations of management include lacking of good and practical diagnostic methods and insufficient choice in medications.
Platelets as Regulators of Wound Healing
Wayne Roberts
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Wound healing occurs through a well-orchestrated series of events encompassing hemostasis, inflammation, cellular proliferation and tissue remodeling. Platelets are specialized vascular secretory cells that rapidly accumulate at sites of injury, quickly becoming the most prevalent cell type. They undergo expansive activation within damaged tissue, initiated by the exposure of extracellular matrix proteins and by the local generation of thrombin. Platelets contain numerous granule types which hold more than 300 biological active components. The content of these granules are released upon platelet activation. A wealth of studies now demonstrates that the contents of these granules are able to regulate most stages of wound healing. In the past two decades an increased understanding of the physiological roles of platelets in wound healing has led to the idea of using platelet products as therapeutic tools to enhance skin repair. This article highlights the mechanisms by which platelets enhance wound closure and discusses the clinical effect of platelet therapy on wound healing.
Exploring Over-The-Counter Medication Use among College Students and the Role of Pharmacists
Olufunmilola Abraham
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Over-the-counter (OTC) medications are easily accessible and allow access to treatment options for people who do not or are too busy to receive care from physicians or other healthcare providers [1]. Consequently, OTC medications provide treatment to 60 million people in the U.S [1]. Besides convenience, OTC medications are also affordable treatment options [1]. Therefore, self-medication is a common practice, particularly with the use of OTC medications [2]. However, this practice puts people at risk of developing adverse events, side-effects, or adverse drug reactions (ADRs) [2]. Additionally, self-medication could lead to misusing or abusing OTC medications [2]. Previous studies have shown that a common misconception about OTC medications is that they are safe [3,4]. However, these medications are only safe when used as directed. This perception that OTC medications are safe is a problem because risks of self-medication include incorrect self-diagnosis, delays in seeking medical treatment, incorrect medication choice, masking of a severe disease, and the risk of dependence or abuse [5].
Drug Prescribing Pattern and Cost Analysis of Antipsychotics at a Tertiary Care Hospital in South India
S. Vedha Pal Jeyamani
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Aim: The aim of the present study was to analyze the cost of Psychiatric drugs in the elderly and to evaluate potentially inappropriate medications (PIMs) in them at the Neurology Outpatient department of a tertiary care hospital using Beers criteria and factors associated with it. Study design: An observational cross-sectional study was carried out in the elderly patients aging ≥ 60 years from the Neurology OPD department for a period of 6 months. PIMS and other risk factors were identified with the help of Beers 2015 criteria. Direct cost of prescribed drugs was calculated making use of guidelines like CIMS, MIMS etc., Results and discussion: Among the psychological conditions evaluated Epilepsy (23.6%) and Schizophrenia (15.6%) were found to be more common among others. Sedative-Hypnotics (39.2%) and anti-epileptics (23.6%) were the commonly prescribed category of drugs. Cost-ratio analysis of Anti-psychotics was found to vary greater when compared to others. Olanzapine (1:12), Chlorpromazime (1:5.1) and Risperidone (1:15) were the prescribed anti-psychotics. All other categories of drugs were found to comply to certain extent with economic status of patients. Antidepressants prescribed posed about 30% patients with PIMs. Typical and atypical anti-psychotics also were PIM with a percentage of 25.7%. Other PIMs due to disease, drug interactions were also studied. Conclusion: A cost-effective management with availing of more economic therapy to the patients could be carried by a clinical pharmacist. Programs encouraging the prescribing of generic drug practice and their benefits compared to brand drugs could be clearly worked out bring more awareness to public.
Paediatric Dosage Forms: A Review of Age Development and Dosage Forms of Choice
Hamad Alyami
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Paediatric medication development has advanced extensively worldwide due to legislative encouragements and requirements directed towards the development of studies of drugs for use in the paediatric population (FDA, 1994). European Medicines Agency (EMA) has reviewed its legislative requirements to drive innovations in paediatric formulations (European Commission, 2013). An approved paediatric investigation plan is required for all new drugs and all line extensions that are submitted for EMA approval after January 2009. Such plans should cover all paediatric age groups. Furthermore, the EMA has issued guidelines on pharmaceutical development of medicines for paediatric use including route of administration, dosing frequency, excipients, patient acceptability, container closure systems and devices and user information (CHMP, 2006, Gauthier and Cardot, 2011). The FDA has issued in 2012, a law requiring the implementation of the Paediatric Research Equity Act and Best Pharmaceuticals for Children Act (Christensen, 2012). Similar to the EMA requirements, a paediatric study plan (PSP) is required for submission and approval by the FDA (FDA, 2013). Oral route of administration is inevitably the most popular route of delivery due to ease of ingestion, availability of a wide variety of dosage forms and most significantly enhanced compliance and adherence. Different drug formulations can be administered orally, including solid and liquid dosage forms (Fasano, 1998, Sastry et al.,).
Effect of Ashwagandharista on Different Hepatic Enzymes at Three Different Dose Level Utilizing Male and Female Rat Model
M. S. K. Choudhuri
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Ashwagandharista (ASG) is a classical Ayurvedic preparation which is used as an anabolic. The key objective of this study was to analyze the effect of ASG on different enzyme profile i.e; Aspartate Aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline Phosphatase (ALP) and Lactate dehydrogenase (LDH). A total of 40 males and 40 females were randomly assigned to the four groups, namely group I (Control: water), group II (0.625 ml/kg BW of ASG), group III (5.0 ml/kg BW of ASG), and group IV (40.0 ml/kg BW of ASG) consisting of 10 males and 10 females in each group. To detect the outcome of ASG on different enzyme profile, it was administered chronically to both male and female Sprague-Dawley rats for 51 days. The results showed significant decrease of serum AST level in ASG treated male rat groups (p < 0.05) than control counterpart. In females, serum AST level in mid dose (group III) was significantly higher as compared to control (p < 0.05). The females from mid dose group showed significant increase in serum ALT level (p < 0.05) whereas other groups from male and female showed no significant changes. For the enzyme Lactate dehydrogenase, only the male rat high dose showed a significant decrease (p < 0.05) than the corresponding control group. No statistically significant change was noted in Alkaline Phosphatase level for both the male and female rats at three different doses.
Ethnobotanical Review of Gynea Diseases
Naveed Raja
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Gynea disease includes different types of diseases suffered by women throughout world. To treat these diseases with herbs is common practice which became less common after 50’s but knows it again becoming popular. Tribal or local women’s use available plants to deal with different diseases. The person under whose guidance this work is done is known by different word in different Tribes of different countries i. e Daye, Hakeem’s, spiritual healers, clergymen, homeopath, Vaidya etc. Different diseases include Gynea cancers, Ectopic pregnancy, Pelvic pain, Sexually transmitted diseases (STD’s), Menstrual problems etc. Literature review had revealed that most common problem suffer by women’s are menstrual disorders while Vulvar cancer occur rarely. Aim of this work was to collect ethno-gynecological information. This review article reveals 400 plants that are used for gynecological diseases treatment alone or mixed either other plants or substances. Inventory include Plant name, Family, Area, Area vernacular name, Part use, Application, Preparation, Disease treated. Literature on Ethnobotanical use in treatment of Gynecological diseases worldwide was collected through online database. Total of 400 plants belonging to 86 families were recorded. Most dominant family is Fabeaceae (43 plants) followed by Amaranthaceae (28 plants) and Asteraceae (24 plants). The current documented study represents the native knowledge used by the tribal people for treatment of different gynecological aliments worldwide.
Monoclonal Antibodies Handling and Administration Risk Management
Jaadar Y
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Background The use of Monoclonal Antibodies (MABs) has provided a new approach to treat various diseases and is in constant evolution. Hospital at home, new regulations and technologies are the next challenges for which healthcare professionals are confronted with. Therefore, risk assessment of MAB handling and administration must be considered. The aim of this study was to develop a tool providing recommendations regarding the MAB handling and administration. Method A review of the scientific literature was undertaken to identify MABs hazard characteristics, their immunogenic potential and their complexity of preparation. A tool was developed to classify MABs requiring a preparation in different groups providing specific handling and administration recommendations. Results An evaluation algorithm was developed to classify MABs regarding their toxicity and complexity of preparation. 28 MABs and 2 fusion proteins were assessed: 6 MABs presented a carcinogenic and/or mutagenic potential in animals. More than 65% of the MABs assessed exhibited teratogenic potential and 25% were highly or moderately immunogenic. 3 groups were defined providing specific recommendations for working staff. MAB side effects were also listed highlighting particular precautions for administration. Conclusion Most of the MABs assessed were not listed in known hazard drug lists (NIOSH, IARC). However, the literature reviewed has highlighted that some MABs exhibit carcinogenic or mutagenic properties in animal studies. Many of them are toxic for reproduction. Furthermore, sensitizing reaction and serious side effects can be observed. Despite their high molecular weight, MABs inhalation (ability to generate aerosol or powder handling) has been described as a potential route of occupational exposure. Studies on humans at low dose exposure should be conducted to allow the establishment of clear safety guidance for MABs handling and administration. 
Management of Drug Toxidermia: Experience of the Pharmacovigilance Service of Oran EHU
Toumi H
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Introduction: Cutaneous reactions are among the most frequently observed adverse effects after drug treatment. They are a common problem, almost daily for doctors and represent an important part of drug iatrogenic. Aims: The objective of this work is to study the cases of cutaneous adverse reactions declared in the pharmacovigilance department of UHE Oran to identify the iatrogenic character of the rash. Material and method: A prospective study was carried out over a period of 30 months from January 2013 to June 2015. It involved 61 notifications accompanied by reporting forms, from different departments of the EHU of Oran. We carried out an analysis of the declaration forms with estimation of the accountability. Results and discussion: The results of our study show that the toxidermia account for 58% of the reported side effects. 61 patients were collected, the average age was 45 years, and there were a female predominance with a percentage of 54%. The dermatology department is the most reputable service with a rate of 41%. The most common clinical forms were: maculopapular exanthema (31.8%) and pruritus (22.9%). The most incriminated drugs were antibiotics (42.2%) and cytotoxics (22.7%). Accountability was plausible in 32.1% cases and likely in 27.6% of cases. Serious toxidermias account for 21% of reported cases with Stevens Johnson syndrome occurring in half of the reported cases and the class of antibiotics was the most incriminated in the occurrence of these reactions. Conclusion: The results of our study have highlighted the importance of surveillance for adverse effects in a hospital setting, as well as the role of pharmacovigilance in the management of patients who have had side effects to the use of drugs.
The Implications of Fixed Dose Combination (FDC) Compared to Single Pill Combinations (SPC): Based on Patients’ View
Emad Makramalla
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Fixed dose Combination (FDC) was mainly presented to simplify complex medical regimens and potentially improve adherence. Therefore, it was advocated in several chronic diseases guidelines in hospitals and health authorities. However, the data on comparison of FDC with their Single Pill Combination (SPC) to improve patient’s medication compliance is limited. Objective: To highlight the implications of FDC medicines compared to SPCs in a tertiary hospital in the United Arab Emirates (UAE). Method: This is a single-center observational retrospective cohort study conducted in a tertiary hospital in the UAE. This study was performed from patient perspective by using a survey on a target of 200 chronic patients using multiple-choice simple questions. The questionnaire was in Arabic—the mother tongue language of the UAE. The inclusion criteria were adult patients over 18 years, able to read and write Arabic, and willing to fill in the questionnaire, has at least one chronic condition and using at least one combination medicine for a minimum of 3 months. Economic impact was also measured based on the pricing lists of the combinations versus single doses, presuming the same clinical effect. Results: Only 67 patients were included in this study, of them 58% males and 42% females. Age groups between 20 and 49 years old showed the highest acceptance of FDC with a percentage of 78%. On the other hand, 70-81 years old were the lowest age group to accept the FDC with a percentage of 27%. Additionally, it was found that 55% of the men aged from 20 to 49 years old had more prevalence of accepting FDC than women from the same age group with 25.9%. Nevertheless, 63% of the included patients were taking five or more medications and were exposed to at least one poly-pharmacy episode and the risk of non-compliance to the medication regimen is reduced. Conclusions: This study is additional evidence that the use of FDCs is encouraging. FDC provides us with a strong armamentarium in chronic disease management. Although there are some advantages and disadvantages of using FDC, it should be considered in patients with chronic conditions for improving.
Extraction and Qualitative Phytochemical Screening of Medicinal Plants: A Brief Summary
Teresa May B. Bandiola
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Phytochemicals are the medicinally active compounds found in plants; parts such as roots, barks, leaves, flowers, seeds, and even pulps. This review focuses on the collection and preparation of plants, the extraction of active compounds, and the qualitative analysis of the phytochemicals present in the plant sample. Novelty is not claimed for the methods described in this paper. Instead, the aim is to review those methods which have been widely used in photochemistry.
Dihydrophenarsazine-based Arsenic-Thio Ethers – Preparation and Stabilization
L Arabuli
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10-chloro-5,10-dihydrophenarsazine (‘adamsite’) was used as starting materials to prepare arsenic-thio ethers: 10- benzothiazolylsulphyde-5,10-dihydrophenarsazine and 10-phenylsulphyde5,10-dihydrophenarsazine. The arsenic organic compounds were synthesized using potassium hydroxide and analyzed by various spectrometric instrumentations. The high toxic and high reactive 10-chloro-5,10-dihydrophenarsazine was converted into stable and low toxic compounds, which will be used as ligands for preparation of metal complexes and biological activity of new compounds will be studied.
Antioxidant, Analgesic, Antimicrobial, and Anthelmintic Activity of the Dried Seeds of Bixa orellana (L)
Utpal Kumar Karmakar
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The present study was performed to evaluate phytochemical groups, antioxidant, antibacterial, analgesic and anthelmintic activity of ethanol extract of seeds of Bixa orellana (Bixaceae). Preliminary phytochemical screening of ethanol extract exhibited the presence of reducing sugar, carbohydrate, saponin, terpenoids, tannins, alkaloids, acidic compound, proteins, steroids, and flavonoids. In the TLCbased qualitative antioxidant assay using DPPH, B. orellana extract showed the free radical scavenging properties that was indicated by the presence of yellow spot on a purple background on the TLC plate. In the quantitative free radical scavenging assay by DPPH, IC50 value was approximately 47 µg/mL, where IC50 value of the ascorbic acid was approximately 16 µg/mL. B. orellana extract displayed hydroxyl radical scavenging activity (SC50 = 157 mg/L) which was comparable to that of standard ascorbic acid (SC50 = 81 mg/L). The Total Phenolic Content (TPC) and Total Tannin Content (TTC) was found to be ~ 52 and ~ 25 mg GAE/gm of dried extract respectively using Gallic acid calibration curve. Total Flavonoid Content (TFC) was ~ 41 mg QE/gm of dried extract using Quercetin calibration curve. The extract showed antibacterial activity against S. aureus, S. dysenteriae, P. aeruginosa, S. typhi, and E. coli at the doses of 250 and 500 µg/disc in comparison with standard drug Fucloxacillin (30 µg/disc) and Ciprofloxacin (30 µg/disc). The extract showed significant (p<0.01) acute peripheral analgesic activity at the doses of 250 (40.34% writhing inhibition) and 500 mg/kg body weight (67.05% writhing inhibition) determined by acetic acid induced writhing method in mice as compared to Diclofenac sodium (79.55%). In anthelmintic activity test, time taken for paralysis and death at the concentration of 25 and 50 mg/mL was approximately 33 minutes and 39 minutes and 23 minutes & 30 minutes respectively whereas standard showed approximately 7 and 16 minutes at the dose of 15 mg/mL respectively against the parasite. The phytochemical groups present in this plant may be responsible for the aforementioned pharmacological effects.