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

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

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.

Assets of Pharmacovigilance, Its Necessity and Future in INDIA in coming five years.

About Authors: Mrugank BP1,  Mangala L2,  Hareesha RP3
Department(s) and institution(s)
1. National Institute of Pharmaceutical Education and Research (NIPER), Department of Pharmacy Practice, M.Pharm (Student)
2. Gauhati Medical College and Hospital (GMCH), Department of Pharmacology, Prof and Head; Chief academic co-ordinator, NIPER-Ghy.
3. National Institute of Pharmaceutical Education and Research (NIPER), Department of Pharmacy Practice, M.Pharm (Student)

Reference ID: PHARMATUTOR-ART-1048

Background: "Pharmacovigilance is the science and activity relating the detection, assessment, understanding and prevention of adverse effects or any other possible drug - related problems." [1]

Literature:Periodic safety update reports (PSUR)[2]and Medical Dictionary for Regulatory Activities (MedDRA)[3]are two important assets for maintenance of Drug safety Pharmacovigilancesystem as they are designed to represent the safety data on a particular drug from all the sources and geographical regions in the worldand to understand internationally, accepted clinically validated medical terminology for medical coding respectively.

Medicated Chewing Gum: A Review

About Authors: Bindi G. Chavda1 ,Vipul P. Patel2, Tushar R. Desai3,
1. Authour, R.K. College of Pharmacy, Kasturbadham, Rajkot.
2. Assistant professor (M.Pharm), R.K. College of Pharmacy, Kasturbadham, Rajkot.
3. Principal (Ph.D), Department of pharmacology, R.K. College of Pharmacy, Kasturbadham, Rajkot.

Reference ID: PHARMATUTOR-ART-1047

Chewing gums are mobile drug delivery systems. It is a potentially useful means of administering drugs either locally or systemically via, the oral cavity. The medicated chewing gum has through the years gained increasing acceptance as a drug delivery system. Several ingredients are now incorporated in medicated chewing gum, e.g. Fluoride for prophylaxis of dental caries, chlorhexidine as local disinfectant, nicotine for smoking cessation, aspirin as an analgesic, and caffeine as a stay alert preparation. In addition, a large number of chewing gum intended for prevention of caries, xerostomia alleviation, and vitamin/ mineral supplementation are currently available. Medicated chewing gums are solid, single dose preparations with a base consisting mainly of gums that are intended to be chewed but not swallowed. Today improved technology and extended know how have made it possible to develop and manufacture medicated chewing gum with predefined properties. Consequently today chewing gum is a convenient drug delivery system, which is appropriate for a wide range of active substances.


About Author: Riddhi M. Katira1, Vipul P. Patel3, Tushar R. Desai4
1. Authour, R.K. College of Pharmacy, Kasturbadham, Rajkot.
2. Assistant professor, Department of pharmaceutics, R.K. College of Pharmacy, Kasturbadham, Rajkot.
3. Principal, Department of pharmacology, R.K. College of Pharmacy, Kasturbadham, Rajkot.

Appropriate for use in this population. These drugs may be prepared extemporaneously for use in individual patients. Physical and chemical properties of drugs and excipients should be considered when preparing extemporaneous formulations. These formulations, however, may lack studies to document stability, bioavailability, pharmacokinetics, pharmacodynamics, efficacy, and tolerability.


Abour Author: Kesinath Kotha*1, Varun Raj Vemula2, Rupesh Kotte3
1. Department of Pharmacy Practice, St Peters institute of pharmaceutical sciences, Warangal, A.P
2. Department of Pharmaceutical Chemistry, Vikas College of Pharmacy, Warangal, A.P.
3. SRR college of pharmaceutical sciences, Karimnagar, A.P.

Chronic obstructive pulmonary disease (COPD) is chronic obstruction of the flow of air through the airways and out of the lungs, and the obstruction generally is permanent and may be progressive over time. According to WHO in India, a study collecting data without spirometry assessment suggested that 12 million people were affected by chronic obstructive pulmonary disease. Recent studies show a prevalence of respiratory symptoms in 6%–7% of non-smokers and up to 14% of smokers. In a recent study in southern India, the prevalence rate of COPD in adults was around 7%. COPD is the fourth leading cause of death in the U.S. and the economic burden of COPD in the U.S. in 2007 was $42.6 billion in health care costs and lost productivity.
In view of its importance, the use of corticosteroids in treatment & management of COPD in acute & chronic conditions has been discussed along with emphasis on recent research trends. Use of corticosteroids & different combination products in the treatment of COPD along with their uses and side effects are presented.


About Author: Naresh Sharma,
M.pharma (Pharmacognosy)
Department of Pharmacognosy, Lachoo Memorial College of Science and Technology,
Jodhpur, India.

Due to Lack of knowledge regarding the toxic effects of synthetic compound in mosquito repellents,synthetic mosquito repellents are widely used. The prolong use of synthetic mosquito repellents shows many side effects like neurotoxic hazards, immunotoxic hazards, skin allergy, seizures, eye irritation, insomnia, impaired congnitive function, cough, sneezing, headache, asthma, bronchial irritation, itching,ear, nose and throat pain, dermatitis, reproductive dysfunction, development impairment and cancer, death. Synthetic mosquito repellents contains very toxic compounds such as DEET, picaridin, permethrin, P?Menthane?3, 8?diol (PMD) etc. These draw backs created a pathway for herbal mosquito repellents coil. Large numbers of herbal drugs are used in these mosquito repellents like Neem, Vekhand, Tulsi, Ajowan, Raal, etc along with other natural ingredients. The efforts are made to study the traditional beliefs from scientific approach. The main aim of this product development is to provide employment to the rural youth and to promote the use of herbal mosquito repellent coil as complete safe alternate of chemical repellents.


Abour Author: RJ Pathyusha B

Reference ID: PHARMATUTOR-ART-1043

The present work describes the local anesthetic activity of milky latex obtained from Calotropis procera and its potentiation with epinephrine and pH. The milky latex at a dilution of 1:10, exhibited significant local anesthetic activity. Both epinephrine (5µg/ml) and pH of 7.2 prolonged the duration of local anesthetic activity. The method used is infiltration anesthesia in Guinea pig. In conclusion, the duration of the effect produced by combination of Calotropis procera latex and epinephrine was longer than that by latex alone.


1.     Research scholar of Jawaharlal Nehru Technological University, Department of Pharmaceutical Analysis, College of Pharmacy, Kakinada, Andhra Pradesh, India.  

Reference ID: PHARMATUTOR-ART-1042

This present study reports for the first time simultaneous quantitation of Amlodipine besylate and Atorvastatin calciumby HPTLC from a combined dosage form.
Methods: Chromatographic separation of the drugs were performed on aluminum plates precoated with silica gel 60 F254 used as stationary phase and the chromatogram was developed using Ethyl acetate: Methanol: Ammonia (7.5 : 2 : 0.5 %v/v/v) as mobile phase. Amlodipine besylate and Atorvastatin calcium showed Rf values 0.50 ±0.02 and 0.26 ±0.02 respectively. Densiometric analysis of both the drugs was carried out in the absorbance mode at 365 nm. The method has been successfully applied to tablets and was validated according to ICH Harmonized Tripartite guidelines.
Results: The linearity regression analysis for calibration showed 0.9983 (r2) and 0.9994 (r2) for amlodipine besylate and atorvastatin calcium with respect to peak area and height in the concentration range of 100-500ng/spot and 200-600ng/spot respectively.  The percentage recovery for amlodipine besylate was found to be 101.82 (at 50%), 99.12 (at 100%) and 101.41 (at 50%), 101.71 (at 100%) for atorvastatin calcium. The limit of detection was 30 ng/spot and    60 ng/spot for amlodipine besylate and atorvastatin calcium respectively. The limit of quantification was found to be 100 ng/spot and 200 ng/spot for amlodipine besylate and atorvastatin calcium respectively.
Conclusion: The developed TLC technique is precise, specific and accurate. It was concluded that the developed method offered several advantages such as rapid, cost effective, simple mobile phase and sample preparation steps and improved sensitivity made it specific, reliable and easily reproducible in any quality control set-up providing all the parameters are followed accurately for its intended use.

Study of Effect of pH on Pioglitazone by UV Spectroscopy and Its Estimation in Bulk and Pharmaceutical Dosage Forms

About Authors: Arun Kumar Dash*, Suchismita Jena, Sudhir Kumar Sahoo
Department of Pharmaceutical Analysis and Quality Assurance
Royal College of Pharmacy and Health Sciences,
Andhapasara Road Berhampur, Odisha

Reference ID: PHARMATUTOR-ART-1040

A simple method for the estimation of Pioglitazone in bulk and pharmaceutical dosage forms has been developed. 0.1N HCl was chosen as the solvent system. The λmax was found to be 270nm and all absorbance values were carried out at 270nm. The responses were linear in the range of 5-100µg/ml. The regression equation of the calibration graph and correlation coefficient were found to be y = 0.026x - 0.020 and 0.999 respectively. The %RSD values for both intraday and interday precision were less than 1%. The recovery of the drug from the sample was ranged between 99.36 and 100.49%. The proposed method was validated for precision, accuracy, intraday, interday assay, robustness and ruggedness. Commercial tablets containing 20mg and 40mg of Pioglitazone were analyzed by the proposed method and the results were well within the claimed limits. Furthermore the effect of pH on Pioglitazone was studied.