Original Research Article

RESTORATION POTENTIALS OF METHANOL AND ETHYL ACETATE FRACTIONS OF Peristophe bicalyculata ON STREPTOZOTOCIN -INDUCED DIABETIC RATS.

JOE ENOBONG ESSIET, ETENG OFEM EFFIOM, IWARA ARIKPO IWARA, JOEL AGHO, EGHOSA, FRIDAY EFFIONG UBOH, PARTRICK EKONG EBONG

Journal of International Research in Medical and Pharmaceutical Sciences, Volume 16, Issue 3, Page 11-21

The fascinating potentials of some medicinal plants in the management of disease and other related complications cannot be over emphasized. Thus, this study investigated the restoration potentials of the ethyl acetate and methanol fractions of P. bicalyculata leaf extract on experimental rat models. A total of thirty five (35) albino Wistar rats were used for the study. They were randomly divided into 7 groups of 5 rats each. Group 1, the standard control, received 250mg/kg body weight (b.wt) of the anti-diabetic drug, Metformin, group 2 and 3 received 200 and 400mg/kg b.wt of the methanol fraction of P. bicalyculata, (group 4 and 5 received 200 and 400 mg/kg b.wt of the ethyl acetate fraction of P. bicalyculata while groups6 and 7 were diabetic and normal control, respectively. There was a significant decrease (p <0.05) in the serum levels of total cholesterol, TG, LDL, VLDL, and increased level of HDL cholesterol in (STZ) induced diabetic treated groups. The studies showed that there was a significant reduction in the fasting blood glucose (FBG) levels of the STZ induced diabetic rats upon treatments with both fractions at 200 mg/kg and 400mg/kg b.wt. Also, the glycated haemoglobin and estimated average glucose concentrations showed a significant decrease (p <0.05) in the low and high doses of P. bicalyculata extract-treated groups compared to the DC. There was no significant (p>0.01) differences in the sex hormones (testosterone, LH and FSH).

Conclusion: The results obtained in the present study provide the scientific rationale of the anti-diabetic potentials of the plant extract on the management of diabetics.

Original Research Article

AN In-vitro ANTI-INFLAMMATORY ACTIVITY OF HYDROALCOHOLIC EXTRACTS AND ESSENTIAL OIL OF SYZYGIUM AROMATICUM

K. KASYAP, SINCHU YESUDANAM, M. L. LAL PRASANTH, C. R. SHIBU PRASANTH

Journal of International Research in Medical and Pharmaceutical Sciences, Volume 16, Issue 3, Page 33-39

Objective: The need of the current study is to explore on the in-vitro anti-inflammatory activity that is the cell membrane stabilizing effect of hydroalcoholic extracts and essential oil by the crude drug Syzygium aromaticum.

Materials and Methods: In this investigation blood sample was withdrawn from healthy human subjects for the preparation of erythrocyte suspension using certain buffers. Then the prepared HRBC suspension was disclosed to essential oil of certain concentration and different graded concentrations of hydroalcoholic extracts from 100 to 1000 μg/mL. The various cytoprotective assays implemented in this research includes HRBC membrane stabilization test, heat induced and hypotonicity induced hemolysis. The standard drug used in this work is Diclofenac Sodium. All the treatment groups were carried out in a triplicate manner and the result obtained is given as Mean ± standard deviation statistically.

Results: It was observed that the in-vitro anti-inflammatory activity of EEZA showed significant result and was effective. The aqueous extracts of the crude drug also showed little anti- inflammatory property. The essential oil also was potent enough to stabilize cell membrane in unheated and isotonic induced hemolytic study at 200 µg/ml.

Conclusion: Thus the present study results explains that EEZA is effective out of all the extracts and essential oil was potent. Thereby this plant can be used in the treatment of various inflammatory ailments.

Review Article

DEVELOPMENT AND MARKETING AUTHORISATION OF BIOSIMILARS IN EU

SUHAS SHANKAR JOSHI, V. BALAMURALIDHARA, AKHILESH AKKI

Journal of International Research in Medical and Pharmaceutical Sciences, Volume 16, Issue 3, Page 1-10

A biosimilar is an item with natural beginning that is exceptionally practically equivalent to and with the shortfall of clinically significant contrasts from a predominant supported organic item. Administrative rules will refresh as often as possible for biosimilar improvement and endorsement. Companies and their contracting partners interested in entering the biosimilar market should be aware of all biosimilar standards and hurdles so that they can answer swiftly to any questions. The biosimilar industry appears appealing due to the potential for cost savings and efficiency, but regulatory, technological, and legal hurdles remain. A marketing permission must be given by the governing agency before any pharmaceutical product can be placed on the market. The primary goal of obtaining marketing authorization is to verify that the product is safe and effective, as well as that it is a high-quality medicine. Biosimilars were approved for the first time in a regulated market in the globe, and they play a vital role in ensuring the safety, quality, and accessibility of human, veterinary, cosmetic, and biological products. The guideline discusses biosimilar product restrictions as well as various fees for product approval. The European Union's regulatory rules and MAA criteria are described in this article.

Review Article

BIOAVAILABILITY AND BIOEQUIVALENCE STUDIES IN INDIA: A GENERIC OVERVIEW

RAJESHWARI S. R., BALAMURALIDHARA V., RAMYASHREE G.

Journal of International Research in Medical and Pharmaceutical Sciences, Volume 16, Issue 3, Page 22-32

In India generic drugs are distributed to public by retail shops as “JANAUSHADHA”. Generics are the drugs which are not branded but they are proven to be bioequivalent to branded drugs. Generic drugs must show similarity with its reference drug in terms of dosage form, strength, API and route of administration. Need of generic drugs in market is high as they are available at reasonable cost, the prime importance is to make the good quality drugs available at lower cost to public. The main objective of the study is to know the process of approval of generics, type of products eligible for BE study and the regulatory aspects for generic approval in India. The regulations for conduct of BA/BE studies in India is set up by Central Drugs Standard Control Organisation (CDSCO). The various regulatory aspects for the development of generic drugs, study design and parameters considered during study and the documentation required the concerned authority has been discussed. The new drug and clinical trial rules 2019 have bought new set of rules which is helpful in conducting BA/BE studies and clinical trials in support with ethical aspects. There is need of more specific guidelines for conduct of BA/BE studies in India for more reliability on generics.

Review Article

MARKET AUTHORIZATION APPLICATION REQUIREMENTS FOR BIOSIMILAR PRODUCTS IN SAUDI ARABIA & SINGAPORE

SUHAS SHANKAR JOSHI, BALAMURALIDHARA V., CHANDAN B. V.

Journal of International Research in Medical and Pharmaceutical Sciences, Volume 16, Issue 3, Page 40-54

Saudi Arabia goes under the centre east nations where the endorsement of biosimilar items gives certain guidelines and endorsement pathway is talked about, Saudi Food and Drug Authority (SFDA) in Saudi Arabia. It assumes a critical part in guaranteeing security, quality and openness of human, veterinary medications, beautifiers and organic items. The rule refers to about guidelines for biosimilar items and different expenses for endorsement of the items. Singapore is arranged in eastern part, which is considered as one of Asian Countries. The method of accommodation is totally extraordinary contrasted with other country. Health science Authority (HSA) is a legal board under the Ministry of Health of the Singapore Government. It is pertinent to clinical, drug and logical ability to secure and propel general wellbeing and security. In this article the administrative rules of Saudi Arabia and Singapore is talked about and looked at the MAA prerequisites in Saudi Arabia and Singapore.

Review Article

ESOMEPRAZOLE MICROCAPSULES: A REVIEW

VISHAKHA VERMA, NATASHA THAKUR, . SIMRAN, BALAMURALIDHARA V.

Journal of International Research in Medical and Pharmaceutical Sciences, Volume 16, Issue 3, Page 55-63

The majority of today’s drug delivery systems are made of bio-degradable, biocompatible and natural bio-polymers, and they can administer drugs at controlled rate. Currently, many research efforts are being made on oral sustained drug delivery system, which is a solid dosing approach. Researchers produced a number of controlled-release and sustained-release dosage formulations by encasing the drug in natural polymer and forming a gel. Micro-beads are characterized as the monolithic sphere that is disseminated throughout the matrix as a molecular dispersion of particle. Esomeprazole microcapsules can also be formulated. Esomeprazole is a drug that is used for treating stomach and esophageal issues (like acid reflux, ulcers). It shows action by lowering the quantity of acid produced by your stomach. It helps symptoms like heartburn, swallowing difficulties, and a persistent cough. This medicine aids in the healing of acid damage to the stomach and esophagus, the prevention of ulcers, and the prevention of esophageal cancer. Proton pump inhibitors (PPIs), such as esomeprazole, are a type of medication. OTC esomeprazole products are used to treat frequent heartburn if you are self-treating with this drug (occurring 2 or more days a week). These medications do not alleviate heartburn immediately away because they take 1 to 4 days to take full action. This review gives information about the methods of preparation and evaluation of esomeprazole microcapsules, along with its advantages and disadvantages.