Articles

AN OVERVIEW ON INTELLECTUAL PROPERTY RIGHTS IN PHARMACEUTICAL PATENT

About Author: A. A. Durgavale*, M. V. Mahale, S. R. Kane, Dr. S. K. Mohite, Dr. C. S. Magdum
Department of Quality Assurance,
Rajarambapu College Of  Pharmacy,
Kasegaon, Tal - Walwa, Dist. - Sangli - 415404

Reference ID: PHARMATUTOR-ART-1058

Abstract
Intellectual Property (IP) refers to property created with the use of intellect. In other words, this refers to creation of mind. These are rights given to person over creation of their minds. They usually give the creator an exclusive right over use of his or her relation for certain period of time. Intellectual property differs from other form of properties as it does not have any physical shape and can be seen. Protection of Intellectual property is done by offering time limited rights to investor in form of patents.
Intellectual property laws vary from jurisdiction to jurisdiction, such that the acquisition, registration or enforcement of IP rights must be pursued or obtained separately in each territory of interest. However, these laws are becoming increasingly harmonized through the effects of international treaties such as the 1994 World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), while other treaties may facilitate registration in more than one jurisdiction at a time. Certain forms of IP rights do not require registration in order to be enforced. There are various forms of IP like Copyrights and related rights, Trade Marks, Geographical Indications, Industrial Designs, Lay out Designs of Integrated Circuits, Protection of Undisclosed Information (Trade Secrets), Patents, Plant varieties.

An Emerging Complication of P. Vivax Malaria with Comparison of P. Falciparum Malaria

About Author: Dr.Ravindra Kembhavi, Asso. Professor PSM Department,
KEM hospital, Parel, Mumbai
Dr.Mahesh Ghadage, M.Sc pharmaceutical 2nd year student,
KEM hospital, Parel, Mumbai

Reference ID: PHARMATUTOR-ART-1057

Abstract
Severe or complicated P. vivax malaria seldom results in pulmonary damage, and pulmonary complications are exceedingly rare while acute renal failure, disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), hypoglycemia, coma, or epileptic seizures this are manifestations of severe or complicated  P. falciparum malaria.

Development and Validation of New Analytical Method for Estimation of Drotaverine in Bulk and Pharmaceutical Dosage Form by UV Spectrophotometry

About Author: Khuntia  Bhabani  S.,  M.Pharm.,  B.P.U.T.,
Department  of  Pharmaceutical  Analysis  and  Quality  assurance,
Royal  College  of  Pharmacy  and  Health  Sciences,  
Berhampur, Odisha, India

Reference ID: PHARMATUTOR-ART-1056

Abstract
The present study includes a simple, sensitive and specific UV method development and validation for the quantitation of Drotaverine in bulk and pharmaceutical dosage form. The λmax was found to be 357nm by taking acetonitrile and water (50:50) as solvent. The validation of the proposed method was carried out as per ICH Guidelines. It was found that the drug was shown the linearity between the range 5-90µg/ml. The regression of the curve was y = 0.022x - 0.033. The developed method was found to be with %RSD 0.548499 for Drotaverine. The %RSD for intra-day and inter-day precision was lower than 2%. The percentage recovery values of pure drug from the reanalyzed solution of formulation were in between 95.68-99.5%. The ruggedness of the method was studied by taking in account of different analyst and by varying the temperature. Based on the performance characteristic the proposed UV method was found to suitable for the estimation of Drotaverine in bulk and pharmaceutical dosage form.

FORMULATION AND EVALUATION OF FLOATING MICROSPHERES OF METFORMIN HYDROCHLORIDE

About Author: Rajyalakshmi Dhulipati (B.Pharm), Janardhanreddy Ramareddy P. (M.Pharm), G. Rajalakshmi (M.Pharm, Lecturer), Dr. N. Damodharan (M.Pharm, Ph.D, Professor & Head of the Department)
Department of Pharmaceutics,
SRM College of Pharmacy, SRM University,
Kattankulathur-603203, Kancheepuram Dist., Tamil Nadu.

Reference ID: PHARMATUTOR-ART-1055

Abstract
The main aim of the study is to formulate and evaluate floating microspheres of Metformin Hydrochloride. Gastro retentive floating microspheres have emerged as an efficient means of enhancing the bioavailability and controlled delivery of many drugs. Floating microspheres of microspheres are formulated in order to achieve an extended retention time in upper G.I.T. which results in enhanced absorption and thereby improving the bioavailability. Floating microspheres were prepared by Non aqueous solvent evaporation method by using Eudragit RS 100 and Eudragit RL 100. The pure drug, the polymers and the physical mixtures were evaluated for FTIR. The prepared Metformin hydrochloride microspheres were evaluated for surface topography, angle of repose, bulk density, tapped density, carr’s index, hausner’s ratio, yield of microspheres, particle size analysis, drug entrapment efficiency, invitro floating ability, invitro drug release and kinetic studies. Results showed that there were no drug incompatibilities and there was good floating ability. SEM revealed the size and surface morphology. The Preformulation parameters were found to be satisfactory. Drug entrapment efficiency was found to be 70-135% and yield was found to be 70-95%. The drug release profiles showed that microspheres prepared with Eudragit RS 100 showed less release when compared to Eudragit RL 100. When Eudragit RL 100 was used in combination with Eudragit RS 100, the release was found to be faster when compared to Eudragit RS 100 alone. The release data obtained were fitted to Higuchi and Korsemeyer-Peppas model to indicate that the mechanism of the drug release was non fickian type of diffusion.

Invitro Anticancer Activity of Alium Sativum and Emblica Officinalis : A New Regimen for Cancer Research

About Author: Vikas Mahajan* (M.Pharm 1st  year), Naiyer Shahzad, Sachin Mager
Singhania University,
Pacheri Bari, Rajasthan - 333515

Reference ID: PHARMATUTOR-ART-1054

Abstract
In this study Cytotoxic potential of two Indian medicinal plant extracts were investigated. The invitro cytotoxic potentiality investigated as the ability of these two extracts to inhibit tumour cell line growth with help of MTT & Trypan blue assay. With this investigation we had also focused on angiogenesis. The cell lines studied are MCF7, A549 and DU145 with the methanolic extract of Alium sativum (MEAS) (garlic) and Emblica officinalis (MEEO) (amla). Both drugs are extracted by maceration method. The extract were concentrated & dissolved in DMSO Solvent & stock solution is prepared of conc. 1mg/10 ml. from which different conc. are prepared as 100, 10, 1, 0.1,0 .001 µg/ml. Both plant extracts preapared concentration are exposed in MCF7, A549 & DU145 in 96 well plate in which MTT dye was added later & allow it for 96 hr. after incubation period absorbance was taken in spectrophotometer at 517nm. With same trypan blue also performed & Counting of cell was done on inverted microscope.  Results indicates that the above plant extracts hsowing anticancer and antiangiogenesis activity of Same plant extract were studied on tube formation cell based models also. From this study we can conclude that both drugs possess anticancer activity for MCF7, A549 & DU145 for different concentrations.

PHARMACEUTICAL PROCESS VALIDATION WHY TO DO, WHEN TO DO AND HOW TO DO IT

About Author: R. C. PATEL, C. K. BHUVA, MR. R. P. SINGH, MR. ABHISHEK DADHICH, MR. ANIL SHARMA.
Department of Quality Assurance, Gyan Vihar School of pharmacy,
Suresh Gyan Vihar University,
Jaipur, Rajasthan, India-302025

Reference ID: PHARMATUTOR-ART-1053

Abstract
Validation has become one of the pharmaceutical industry’s most recognized and discussed subjects. It is a critical success factor in product approval and ongoing commercialization. This article provide brief introduction about the pharmaceutical process validation and its importance according to regulatory provision, also provide the answer of question like why to do, when to do and how to do it. This work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process. Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. In pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000:2000, it had proven to be an important tool for quality management of pharmaceuticals.

EFFECT OF TECTONA GRANDIS STEM EXTRACT ON ESTRADIOL BENZOATE INJECTED UTERUS OF FEMALE ALBINO WISTAR RATS

About Author: Deepali Jaybhaye, Sushilkumar Varma, Amol Gite
Department of Pharmacology, Mahatma Gandhi Mission Hospital,
Aurangabad, Maharashtra – 431001, India.

Vijay Bonde
Department of Pharmacology, Mahatma Gandhi Institute of Medical Sciences,
Sewagram, Wardha, Maharashtra – 402102, India.

Reference ID: PHARMATUTOR-ART-1052

Abstract
Tectona Grandis linn. is one of the well known Indian herbs. In Ayurveda Tectona grandis stem extract has tocolytic effect. The main syndrome of preterm birth is caused by uterus contractions from excitatory factors. Administration of tocolytic agents is a strategy to prevent the occurrence of preterm births. The aim of this study was to investigate the effects of Tectona grandis stem extract on the contractions of uterine strips isolated from non?pregnant female Wistar rats (250~350 g) prior injected (Before 24 Hrs) Estradiol benzoate. Contractions of the uterus were induced with Oxytocin 0.01 IU. The results compared with stander drugs like Magnesium Sulfate (75 mg), Nifedipine (0.18 mg), and Isoxsuprine (0.18 mg) along with their effect on frog blood vessels, rat and frog heart, skeletal muscle. After seeing these effects we conclude that Tectona grandis stem extract possess the same tocolytic effect as that of standard drugs.

Effect of HPMC On Carbamazepine Nasal Mucoadhesive Microspheres: Preparation And Evaluation

About Author: Imran A. Kayyum. Tadwee1*, Sadhana Shahi1, Mahesh Thube1
Government College of Pharmacy,
Aurangabad, Maharashtra, India

Reference ID: PHARMATUTOR-ART-1051

Abstract
The object of this work is to formulate & observe the effect of HPMC K15 polymer on various parameters of evaluation of carbamazepine nasal mucoadhesive microspheres. The microspheres are prepared by spray drying technique with different formulation composition of HPMC K15. The microspheres obtained are meant for the evaluation for its production yield, particle size, swelling ability, Drug content, encapsulation efficiency and Invitro drug release study. IR, TLC study is performed for drug Polymer interaction study of the optimized batch. Morphology is studied be SEM. The results obtain shows that the release rate of the drug decreases and particle size, production yield, swelling index, encapsulation efficiency, mucoadhesion is increases with increase in drug: polymer ratio. TLC study shows no interaction of Carbamazepine and HPMC. SEM study reveals the encapsulation of drug in the HPMC K15 Polymer. The data obtained after Invitro release study fitted to PCP disso software for mechanism of release & kinetic model. The data also treated with design expert software v 7.1 it shows the model is significant. Overall it shows that the polymer HPMC does not posses any interaction with the carbamazepine and showing controlled drug release behavior.

A Review on Conduct and Analysis of Bioavailability and Bioequivalence Studies

About Author: 1. Shah Dhaval D., M.Pharm-II Semester, Quality Assurance Department, Gyan Vihar School of Pharmacy, Jaipur, India
2. Sharma Anil, M.Pharm, H.O.D. Quality Assurance Department, Gyan Vihar School of Pharmacy, Jaipur, India

Reference ID: PHARMATUTOR-ART-1050

Abstract
Generic pharmaceutical products need to confirm to the same standard of quality, efficacy and safety as required of the originator’s (innovator) product. Spefically, the generic product should be therapeutically equivalent and interchangable with the reference product. Testing the bioequivalence between a test product pharmacetically equivalent or a pharmaceutical alternative and a suitable reference product in a pharmacokinetic study with a limited no of subjects is one way of demonstrating therapeutic equivalence. Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical and clinical data to establish safety and effectiveness. This article provides the information about important aspect involved in bioequivalence and regulatory requirment for bioequivalence study.

Co-processed excipients: an overview of formulation aspects, physical characteristics and role as a pharmaceutical-aid

About Authors: Biswajit Panda1*, Abhinav Raoot1, Vaishali Kilor1, Nidhi Sapkal2
Dept of Pharmaceutics1 and Dept of Pharmaceutical Chemistry2
Gurunanak College of Pharmacy, Nagpur

Reference ID: PHARMATUTOR-ART-1049

Abstract
Excipients are all substances contained in a dosage form other than the active substance. Tablets are the most commonly used dosage form because of the ease of manufacturing, convenience in administration, accurate dosing and stability compared to oral liquids and direct compression is the preferred method for the preparation of tablets because of several advantages. In order to justify the high rise in new drug development and high industrial output demand, new excipients with purpose satisfying characteristics are the need of the hour.New combinations of existing excipients are an interesting option for improving excipient functionality now-a-days. The current review article is prepared to have a look over the recent development in excipient technology and the approaches involved in development of such excipients. It signifies the synergistic outcome of the combination of excipients taking their material property into consideration. It also emphasises on the particular material properties in terms of physic-mechanical that are useful to overcome the limitation of existing excipients. All the developed co-processed excipients are enlisted highlighting their multi-functional and beneficial characteristics. Regulatory issues concerned with the development of new excipient are also discussed.

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