Journal of Pharmaceutical Research

1-6

Authors: Narges Shokri, Hamid Akbari Javari

Objectives: Dermal delivery is an excellent route of drug administration. In this study, Zinc Oxide nanoparticles(ZnO-NPs) and 6 solvents were used as enhancers to promote dermal permeation of collagen. Methods: Formulations contained collagen, solvent and ZnO-NPs. Permeation of collagen was determined by an ex vivo (animal skin) method. Results: Using sunower oil, olive oil, coconut oil, liquid parafn, dimethyl sulfoxide or tetrahydrofuran, lead to permeation of 46, 47, 60, 241, 56 and 35 mg collagen, respectively. Addition of 200 mg ZnO-NPs, resulted in permeation of 68, 61, 72, 286, 63 and 47 mg collagen, respectively. Using 300 or 400 mg ZnONPs and liquid parafn, lead to permeation of 299 and 286 mg collagen, respectively. Conclusion: Using the solvents or ZnO-NPs enhanced the permeation of collagen. The enhancement was more when a solvent and ZnO-NPs were used simultaneously. Among them, combination of liquid parafn and ZnO-NPs, showed a synergistic enhancing effect leading to the maximum permeation observed in the study. This was explained with the completely different enhancing mechanisms of liquid parafn and ZnONPs. Therefore, the study suggests using liquid parafn and ZnO-NPs or other combinations of enhancers having distinct mechanisms to prominently improve the permeation of collagen.

15-19

Authors: A. Suneetha, K. Manasa, S. Lakshmi Sindhura

Objective: To develop and validate a simple, selective, rapid and stability indicating reverse phase high performance liquid chromatographic (RP-HPLC) method for the analysis of Lurasidone HCl in bulk and its tablet dosage forms. Method: Several trials were made by changing the mobile phase composition and nally the drug was resolved on a Thermo ODS, C18, (150 X 4.6 mm, 5μ) column, using the mobile phase consisting of sodium dihydrogen ortho phosphate buffer (pH 6.5) and acetonitrile in 60 : 40 ratio and pumped at a ow rate of 0.8 ml/min at ambient temperature. Studies were performed on Waters HPLC system equipped with PDA detector, the response was monitored at 230 nm. The developed method was validated as per ICH guidelines. Results: The retention time of Lurasidone HCl was found to be 3.33±0.02 minutes. The calibration curve was linear over the concentration range of 10-60 μg/ml (r2=0.9999). The limit of detection for Lurasidone HCl was found to be 0.25 μg/ml and the quantication limit was about 0.75 μg/ml. The accuracy of the method was established based on the recovery studies and the percentage recovery was in the range of 99.95 to 100.01. The drug was degraded in all the conditions like acid, alkali, oxidative, thermal and photolytic conditions by proposed RP-HPLC method. Research Value: The proposed method can be applied for the routine analysis of Lurasidone HCl in bulk and its pharmaceutical dosage forms in quality control laboratory.

26-32

Authors: Kaur Ramandeep, Gupta Vikas, Chirstopher Ajay Francis, Bansal Parveen

Purpose: This communication highlights the scope of clinical trials in herbal drugs and various problems being faced by herbal drug scientists, herbal drug industry in development of new herbal products that have to undergo clinical trials in all the countries to enhance global acceptance. Social Implications: Herbal drugs have been used since ancient times as medicines for the treatment of different diseases. It is the oldest and most popular form of healthcare practice known to humanity for maintenance of health that has been practiced by the people of all the societies throughout the history of evolution. Herbal medicines are also known as "the people's medicines" because of their easy accessibility, safety, ease of availability and self medication. Particularly in countries like India, many of herbal drugs and formulations are used in different practices of treatment like Ayurveda, Siddha and Unani. Research Implications: It is expected that more than 25% of all modern medicines are directly or indirectly derived from plants sources yet the contribution of developing countries in global herbal business is very poor due to lack of quality control and standardization measures. There is lack of common standards and appropriate methods for evaluating Traditional Medicine to ensure safety, efcacy and quality control. This indicates the importance and requirement to develop a standard operational procedure for the standardization of herbal drugs and formulations. Original value: Quality control, quality assurance, safety and efcacy of herbal drugs are the bench mark in the evaluation protocols and that would play a major role in providing highly reliable and effective herbal drugs to attract international trade, thus generating returns. Approach: For this study internet search engines and various documents available for drug regulatory affairs were screened. Problems faced by different scientist groups were analyzed and compiled from internet sources. Findings: The study highlights a very good scope of clinical trials in herbal drugs. It also highlights stringent guidelines for conduct of clinical trials in herbal drugs that needs little bit relaxation by regulatory agencies. Conclusion: The conclusion drawn from this review is that presently developing countries lack the necessary guidelines for clinical trials on Ayurvedic/natural/herbal medicines. If the WHO guidelines can be adopted in developing countries to approve clinical studies without the need for stringent safety data, clinical trials on Ayurvedic medicine can be encouraged to be at par with pharmaceutical products.