Journal of Pharmaceutical Research

71-80

Authors: Preeti Sudheer, Hemanth Kumar, Litha Thomas, D. R. Nethravathi

Background: The gastro-retentive system is one of the promising oral drug delivery system due to its ability to remain in the gastric region for a longer period. This helps in improving the bioavailability by increasing the solubility and reducing drug wastage. Approach: Various approaches have been put forward to achieve the gastro-retentive property. Among them, floating (hollow) microsphere is the most prominent approach. Findings: Hollow microspheres are spherical free flowing powders in the size range of 1-1000 m without core. It is prepared using proteins or synthetic polymers. This buoyant system improves gastric retention, sustains the drug release, and hence reduces the fluctuations in plasma drug concentration. Conclusion: This review presents an insight into recent advances in methods of fabrication, evaluation and applications of hollow microspheres as gastro-retentive drug delivery systems.

90-93

Authors: Ch. Kantlam, M. Srinivasa Murthy, Y. Narsimha Reddy

Purpose: The present research work is aspired to describe the synthesis, characterization and antibacterial activity of novel Mannich derivatives (4a-4f) derived from apocynin. Methodology/ Approach: In the present work, a novel chalcone was prepared by Claisen-Schmidt condensation of apocynin with benzo[b]furan aldehyde. Mannich bases were prepared by reaction of 3- (benzofuran-2-yl)-1-(4-hydroxy-3-methoxyphenyl)prop-2-en-1-one with formaldehyde and 2o amines. Findings: All the newly synthesized Mannich base derivatives were characterized by their IR, NMR and Mass spectral data. Further all these final compounds were evaluated for their antibacterial activity using norfloxacin as standard reference. It was observed that among the final derivatives (4a-4f), compounds incorporated with morpholino, piperazino and piperidino moieties (4c-4e) exhibited excellent antibacterial activity, while the compound (4f) with pyyrolidino substituent showed similar promising activity and other compounds (4a-4b) possessed moderate activity. Original Value : The review of literature revealed that conversion of various acyclic conjugated α,β- unsaturated ketones e.g. chalcones, into the corresponding Mannich bases was often accompanied by increased bioactivity both in vitro and in vivo. These facts prompted us to synthesize novel Mannich base derivatives having better biological activity. All the synthesized compounds were screened for their in vitro antibacterial activity. Conclusion: The study revealed that compounds (4c), (4d) and (4e) derivatives exhibited highest activity against the tested bacteria.

98-101

Authors: Chilukuri Paramathma

Objective: In India, where market has thousands of trade name medicines and prescriptions of doctors are usually in illegible handwriting there is high probability of dispensing and medication errors due to look-alike sound-alike (LASA) trade names. This study is an attempt to correlate doctor's handwriting and confusion of trade name to develop a help list of confusing product names. Methodology: A total of 5472 prescriptions presented for dispensing during a period of six months were studied and analyzed to determine and identify the confusing trade names, so as to design a ready made list of such products which will serve as a cautionary reference for avoiding dispensing errors. Findings: Potentially confusing trade name pairs of medicines available in local market of Andhra Pradesh, India were paired out and categorized. A list of 55 pairs of almost identical trade names was compiled, which shall serve as a ready reference for pharmacists while dealing such prescriptions. The list has been arranged alphabetically for ease of reference. Practical implications: It recommends three step audit of prescription before final dispensing to avoid any potential error. Originality/value: This research shall have direct implication on reducing chances of wrong dispensing due to poor/illegible handwriting of doctors. Conclusion: Several trade names are almost identical orthographically or phonologically with very minor difference in spelling but having entirely different pharmacological, therapeutic and toxic effects. Preventing such possible confusion during dispensing of prescription shall have great medical and social value. The help list developed shall serve as a ready reckoner for safe dispensing of prescriptions.

57-60

Authors: N. Narayanan, R. Gowri, A. Maheswaran, G. Harshapriya, N. Deattu, N. R. Ravi Nargis

Purpose: WHO estimates that more than 346 million people worldwide have diabetes. Majority of the population today is not just trying to be economically successful but also aim to stay fit and free from dreaded chronic diseases. This investigation aims to evaluate the health conditions of people from remote areas who have less possibility of utilizing the urban health facilities of India. Methodology: A cross sectional study was conducted to clinically assess diabetes in rural population ofThiruvaliurdistrict by using a predesigned and pretested protocol to find out the prevalence and the risk of diabetes mellitus in general population. The study mainly focuses on rural population so as to suggest possible treatment and remedial aspects. Various studies in the test used are based on simple anthropometric, demographic and behavioral factors to detect undiagnosed diabetes. The responses for the questions were collected, evaluated and statistically analyzed. Findings: Out of 250 subjects, only 5% showed symptoms of diabetes (first time diagnosis) and among them half were in the early stage of the disorder. Conclusion: This study reveals that diabetes awareness prevailed among selected individuals about the hygienic system and life style. It was found that people acquired maximum knowledge with better understanding of the disease, better impact on the progression ofthe disease and complications by patient counseling through verbal and pictograms.

66-70

Authors: Malathi Raghunath, Amol Dhamne

Background: Ciprofloxacin Hydrochloride (CPX) is a fluoroquinolone antibacterial. Tinidazole (TNZ) is a nitroimidazole anti protozoal while dicyclomine hydrochloride (DIC) is an anticholinergic antispasmodic agent. The three drugs in their fixed dose combination are frequently administered in typhoid fever and infections of mixed origin. Purpose: The aim of the present research was to develop a reversed-phase high-performance liquid chromatography method for simultaneous estimation of CPX, TNZ and DIC in bulk and combined tablet formulation. Methodology: HPLC system used was Thermo Finnigan coupled to a variable wavelength UV detector and was operated in isocratic mode. The data acquisition was carried out using Chrome Quist software. The separation was achieved using HiQ Sil C18 column having dimensions 250 x 4.6 mm i.d. with a particle size of 5 ~m. The mobile phase consisted of buffer pH 4.0 and methanol combined in ratio of 60:40 v/v. The flow rate and UV detector was set at 1 ml/min and 218 nm respectively. Findings: The order of elution of all three drugs was found to be TNZ (5.42 min), DIC (6.96 min) and CPX (8.04 min). The linearity was established in the range of 5-30 ~g/ml (CPX and TNZ) and 250-650 ~g/ml (DIC). The method was validated in accordance with ICH guidelines. Conclusion: From this study it was concluded that the proposed RP-HPLC method is accurate, reproducible and precise. Application: The developed method was then successfully applied for simultaneous estimation of these drugs in marketed tablet dosage form.

33-41

Authors: K. A. Gulma, M. Abubakar, B. L. Mohammed, B. Musa, S. Nata'ala, M. I. Yusuf, N. Jibril, S. A. Abdullahi, M. S. Hashim

Purpose – The objective of this research is to assess stock of health commodities used in the management of HIV/AIDS and tuberculosis in Kano State, Nigeria. This assessment will reveal the sum of stock levels available at the state warehouse and health facilities, then determining for how long they can last. Approach – Data from Logistics Management Information System (LMIS) tools for the last quarter of year 2014 were obtained and information on 'stock on hand' and 'average monthly consumption' were extracted for analysis. Computer applications- MS Word and MS Excel were used generate charts depicting month of stock that are used to explain the results. Findings – Prior to the conduct of Quarterly Stock Status Report (QSSR), the best conclusion everyone could make is either a health facility is overstocked or is out of stock. But QSSR brings a clear state-wide picture of the status of all facilities put together which forms the comprehensive outlook of the entire state. Research limitations –The limitation of this research is availability of LMIS data on consumption and stock on hand of other health commodities similar to manner HIV/AIDS and Tuberculosis are recorded regularly. Practical implications - If appropriate action is taken based on the results obtained, there will be leverage of health commodities across the entire length and breadth of the state. Originality –The research is the rst of its kind in Kano and is important not only in assessment of stock status and importance of actions taken from the result thereof but is also very signicant in forecasting and quantication of health commodities.

45-50

Authors: Mohammed Gulzar Ahmed, A. Acharya, R. Chaudhari, K. Panicker, R. Reddy

Objective: The main objective of present study was to formulate and evaluate methyl cellulose based in situ gel of rosuvastatin for the treatment of periodontal diseases. Methods: The rosuvastatin in situ gel was prepared by using different concentration of methyl cellulose as gel base and gel was evaluated for pH, viscosity, rheology, drug content, syringeability, spreadability, drug release and drug release kinetics studies. Results: Compatibility study was performed using FT-IR and results showed there was no interaction between drug and other excipients. Viscosity of all formulations was found in the range of 320-590 centipoise and all formulations exhibited shear thinning pseudoplastic behaviour. Gelation time and temperature was found in the range of 2-15 min and 26oC-39oC respectively. All the formulation except formulation F6, F7 and G8 passed syringeabilitytest, as these formulations easily gets expelled from the syringe. An in vitro release study was conducted using 1.2 pH buffer for 8 hours and results showed that formulation F5 containing 0.9% methyl cellulose was considered as optimum formulation as it released 54.33% drug at the end 8 hours. In vitro release study revealed that release rate of drug from the in situ gel was concentration dependent; as concentration of methyl cellulose increased the drug release rate was retarded. Conclusion:Thus, it can be concluded that formulation F5 containing 0.9%w/v of methyl cellulose as gel base was considered as an optimized formulation, as it release drug in sustain manner in the treatment of periodontal diseases.

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.