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I take the privilege to present the print version for the Volume 1 Issue (3) of Trends in Drug Delivery. The intension of TDD is to create an atmosphere that stimulates creativeness, research and growth in the area Drug Delivery. The development and growth of the mankind is the consequence of brilliant Research done by eminent Scientists and Engineers in every field. TDD provides an outlet for Research findings and reviews in areas of Drug Delivery found to be relevant for National and International recent developments & research initiative. The aim and scope of the Journal is to provide an academic medium and an important reference for the advancement and dissemination of Research results that support high level learning, teaching and research in the domain of Drug Delivery. Finally, and Authors for their continued support and invaluable contributions and suggestions in the form of authoring I express my sincere gratitude and thanks to our Editorial/ Reviewer board write ups/ reviewing and providing constructive comments for the advancement of the journals. With regards to their due continuous support and co-operation, we have been able to publish quality Research/Reviews findings for our customers base. I hope you will enjoy reading this issue and we welcome your feedback on any aspect of the Journal.

Dr. Archana Mehrotra Director STM Journals

Trends in Drug Delivery

Contents

1. Pharmaceutical Product Registration and Requirements in CIS Countries Rahman F., Dixit M., Charayulu R.N., Daniel S., Rasheed A.

2. Pharmaceutical Products Registration Requirements for ASEAN and GCC Countries Daniel S., Dixit M., Charyulu R.N., Rahman F., Rasheed A.

3. Assessment of Self-Medication Practice and Drug Storage on Private Pharmacy Clients in Jimma Town, Oromia, South West Ethiopia Abdissa Ararsa, Anbessa Bekele

4. Monophase Solution for Enhancing Solubility and Dissolution of Ezetimibe by Spray Dried Microparticle Mudit Dixit, Parthasarthi Keshavarao Kulkarni, R Narayana Charyulu

5. Prescriber's Adherence to the Basic Principles of Standard Prescription Order Writing in Dessie Referal Hospital, South Wolli Zone, Northern Ethiopia Tekola Belachew, Anbessa Bekele

Trends in Drug Delivery Volume 1, Issue 3 www.stmjournals.com

Pharmaceutical Product Registration and Requirements in CIS Countries Rahman F.*, Dixit M., Charayulu R.N., Daniel S., Rasheed A. Department of Regulatory Affairs, NGSM Institute of Pharmaceutical Science, NITTE University, Mangalore, Karnataka, India Abstract Commonwealth of Independent States (CIS) has been identified as one of the emerging markets due to the phenomenal growth of the pharmaceutical industry. It has estimated that pharmaceutical sector in Russia and other CIS nations with CAGR of 10–11% during the year 2012–2016. Russia holds 14% of CIS market in 2013 whereas pharmaceutical market in Ukraine and Kazakhstan contributed to 3–4%, respectively. The Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor) is a regulatory authority of the Russian. The format for pharmaceutical registration is Common Technical Document (CTD). In 2010, India and Russia have signed a Memorandum of understanding (MoU) for cooperation in the pharmaceutical trade and industry and have implemented the same. Thus this paper mainly focuses on the registration requirements for CIS countries namely Russia, Ukraine and Kazakhstan and scope for Indian pharmaceutical industry in CIS market.

Keywords: Common Technical Document (CTD), International Conference of Harmonisation (ICH), pharmaceutical, Memorandum of Understanding (MoU), CIS nations

Trends in Drug Delivery Volume 1, Issue 3 www.stmjournals.com

Pharmaceutical Products Registration Requirements for ASEAN and GCC Countries Daniel S.*, Dixit M., Charyulu R.N., Rahman F., Rasheed A. Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, NITTE University, Mangalore, Karnataka, India Abstract Registration of pharmaceutical products is a challenge and an important task in regulated, semi regulated as well as rest of the world countries. Although the requirements are harmonized in regulated countries by Common Technical Document (CTD) filing, yet others have enormous diversity in requirements. The purpose of the present study is to understand the requirements for registration of drug products in countries like the Association of South East Asian Nation (ASEAN) and Gulf Cooperation Council (GCC).In the ASEAN and GCC region, A-CTD filling procedure and CTD format is used, respectively. The optimization in requirements is mandatory and can be judged by the incidence of higher cost involved in the availability of drugs, research and development facilities. For better treatment, safety and efficacy the drugs must be justified and rationalized for public security. The study also provides the challenges and barriers faced by the emerging markets (ASEAN). The commercial significance of markets is increasing globally. It is vital for pharmaceutical industry to cope with the regulatory requirements for betterment of public and ensure their place in the market.

Keywords: CTD, ACTD, ASEAN, GCC

Trends in Drug Delivery Volume 1, Issue 3 www.stmjournals.com

Assessment of Self-Medication Practice and Drug Storage on Private Pharmacy Clients in Jimma Town, Oromia, South West Ethiopia Abdissa Ararsa, Anbessa Bekele* Department of Pharmacy, College of Public Health and Medical Sciences, Jimma University, Ethiopia Abstract A number of individuals in developing countries do not attend physicians for their illnesses, instead they commonly use self-medication. Self-medication could be using drugs existing in home like over the counter (OCT) drugs, traditional medicine, prescription only drug. Self-medication is not always bad; hence for the over the counter drugs, it is beneficial. Most of the time drugs stored on unsafe place may result in decrease in drug's efficacy. The objective of this paper is to assess self-medication and drug storage conditions on private pharmacy clients in Jimma town. A community-based cross sectional prospective study had been conducted in Jimma town from June 28 to July 14, 2013 GC. The data had been collected by semistructure-questionnaire consisting questions on general demographic, socio-economic as well as on perceived illness/symptoms in the past one year and actions taken for it and administered to respondents of 405 systematically selected client. The collected data had been analyzed by using calculator.

Keywords: Self-medication practice, drug storage, private pharmacy clients

Trends in Drug Delivery Volume 1, Issue 3 www.stmjournals.com

Monophase Solution for Enhancing Solubility and Dissolution of Ezetimibe by Spray Dried Microparticle Mudit Dixit1*, Parthasarthi Keshavarao Kulkarni2, R Narayana Charyulu1 1

Department of Pharmaceutics, NGSM Institute of Pharmaceutical Sciences, NITTE University, Mangalore, Karnataka, India 2 Department of Pharmaceutics, JSS College of Pharmacy, JSS University, Mysore, Karnataka, India

Abstract The aim of the present study was to improve the solubility and dissolution rate of Ezetimibe by preparing crystals by spray drying technique using Isopropyl alcohol (IPA) and water as solvent system. Ezetimibe crystals were produced by spray drying using IPA as solvent to enhance solubility and dissolution rate. The prepared crystals were evaluated for solubility and in vitro dissolution. The prepared formulations were characterized by differential scanning calorimetry (DSC), Fourier transform infrared (FT-IR) spectroscopy, X-ray diffraction (XRD) and scanning electron microscopy (SEM). Dissolution profile of the prepared spray dried crystals was compared with its recrystallized and pure sample. Spray dried crystals exhibited decreased crystallinity. The solubility of spray dried crystals exhibited two-fold increase as compared to the commercial Ezetimibe and dissolution showed 59% release in 60 min. Consequently, from the above result it can be concluded that spray dried technique is a useful technique to improve the solubility and dissolution of poor water soluble drug like Fenofibrate.

Keywords: spray drying, crystals, Ezetimibe, crystallinity, solubility

Trends in Drug Delivery Volume 1, Issue 3 www.stmjournals.com

Prescriber’s Adherence to the Basic Principles of Standard Prescription Order Writing in Dessie Referal Hospital, South Wolli Zone, Northern Ethiopia Tekola Belachew1, Anbessa Bekele2* 1

Dessie Referal Hospital, South Wolli Zone, Ethiopia Department of Pharmacy, College of Public Health and Medical Sciences, Jimma University, Ethiopia

Abstract Objective of the paper is to assess prescriber’s adherence to the basic principles of prescription order writing in Dessie Referal Hospital, for which a retrospective study was conducted using a sample of 384 prescriptions. A prescription was selected using simple random sampling technique. Data was collected using check list and analyzed using hand tallying and scientific calculator. Study shows good adherence for some variables and poor adherence for other variables. In-service training should be provided to prescribers to promote rational prescription.

Keywords: Prescriber’s adherence, basic principles of prescription writing, standard prescription