IAJPR

Indo American Journal of Pharmaceutical Research

ISSN NO.: 2231-6876
  • INDEXING
  • PUBLICATION CERTIFICATE
  • Impact Factor Journal
NOVEMBER 2018
1

FORMULATION AND INVITRO EVALUATION OF MOUTH DISINTEGRATING TABLETS OF MONTELUKAST AND DESLORATADINE

K. L. Deepthi*1, B. Chatrapathi, R. Bhaskar, B. Jairam, L. Gagan Kumar
Sri Venkateswara College of Pharmacy, Srikakulam, Andhra Pradesh-532001.

Montelukast sodium is a leukotriene receptor antagonist, used in the treatment of asthma and Desloratadine is a drug used to treat allergies. The combination formulation is used for the treatment of allergic rhinitis, chronic urticaria. The aim of the present study is to Formulate and evaluate the oral disintegrating tablets of Montelukast sodium and Desloratadine. ODTs were prepared by direct compression method and by using crospovidone, croscarmellose sodium and sodium starch glycollate as superdisintegrants which disintegrates in matter of seconds in the oral cavity, thereby reducing the time of onset of pharmacological action and to reduce the first pass metabolism . Magnesium stearate was used as a lubricant, aspartame as sweetener and orange flavour is used to improve mouth feel.Montelukast sodium is a leukotriene receptor antagonist, used in the treatment of asthma and Desloratadine is a drug used to treat allergies. The combination formulation is used for the treatment of allergic rhinitis, chronic urticaria. The aim of the present study is to Formulate and evaluate the oral disintegrating tablets of Montelukast sodium and Desloratadine. ODTs were prepared by direct compression method and by using crospovidone, croscarmellose sodium and sodium starch glycollate as superdisintegrants which disintegrates in matter of seconds in the oral cavity, thereby reducing the time of onset of pharmacological action and to reduce the first pass metabolism . Magnesium stearate was used as a lubricant, aspartame as sweetener and orange flavour is used to improve mouth feel 




2

INVITRO ANTIOXIDANT CAPACITY AND FREE RADICAL SCAVENGING ACTIVITY OF VARIOUS ANTI DEPRESSANT DRUGS

Abhijit De*1, Manisha Singh2, Partha Chattopadhyay3
1Bengal School of Technology, Hooghly, West Bengal, India.

2Dr. Hari Singh Gour Vishwavidyalaya, Sagar, Madhya Pradesh, India.

3National Institute of Pharmaceutical Education and Research (NIPER), Guwahati, India.

One of the major cause of depression and propagation of depression is oxidative stress and this leads to further complications like Parkinson’s disease, Alzheimer’s disease and other neurodegenerative conditions. Current study involved different reuptake inhibitors used in combating depression and the antioxidant activity. DPPH radical scavenging assay, Nitric oxide radical scavenging assay, FRAP, Phosphomolybdenum assay and assessment of inhibition of lipid peroxidation- these five methods were adopted for investigation of the antioxidant activity of Modafinil, Fluoxetine, Duloxetine and Vilazodone. This study indicated Modafinil as best DPPH radical scavenger, vilazodone as the best scavenger of nitric oxide radicals, duloxetine as the drugs with best reducing potential and fluoxetine as the best drug to inhibit lipid peroxidation amongst the four drugs. These findings suggest that these reuptake inhibitors have the radical scavenging capacity which may show beneficial effect in controlling depression besides their established pharmacological profile. 


 


3

REVIEW ARTICLE: QUALITY BY DESIGN (QbD)

Mimansha Patel
Department of Quality Assurance, India.


There is massive competition worldwide and growing impact of Information technology, the pharmaceutical industry needs to improve its performance. Newer technologies need to be implemented that can effectively reduce cost of production and at the same time improves product quality and regulatory compliance. Quality by Design is an approach that has been offered by the United States Food and Drug Administration (USFDA) which if implemented properly can save significant amount of time and cost and at the same time can improve final product quality and regulatory compliance which can increase the speed of product to reach in to the market for the patient safety. This article discusses the background of quality by design concept, basis of Quality by Design, and its approach across the product life span and benefits that it offers 

 


4

“FORMULATION AND EVALUATION OF CONTROLLED RELEASE TABLET DOSAGE FORM OF NAPROXEN SODIUM USING BILAYER TECHNOLOGY”

Dr. M. Sunitha Reddy*, Goparaju Ramya, S. Muhammad Fazal Ul Haq
CPS, IST, JNTUH.

The goal of present study is to formulate and evaluate controlled release dosage form of Naproxen sodium using bilayer tablet technology, by wet granulation process. During this wet granulation process various parameters were studied like granulation , dried granules LOD, compression parameters and formula was optimized. In this wet granulation process various controlled release polymers were used like HPMC K4M, HPMC K15, HPMC K 100. Among the used polymers HPMC K4M Showed the high retarding the drug release rate, due to it contain high viscosity in nature. The drug and excipient computability studies and Preformulation studies were performed. In vitro dissolution test was performed by using USP type II (Paddle) apparatus, 1000 ml of phosphate buffer pH7.5 and the paddle was rotated at 50 rpm at temperature (37ºC ± 0.5ºC) similar as that of reference listed drug. The finished tablets were subjected to evaluation parameters and study on pH of different media were studied on controlled release tablets. Three months Stability studies indicate that it was similar as that of innovator product 


 


5

EVALUATION OF LEPIDIUM SATIVUM SEED MUCILAGE AS A BINDER IN TABLET FORMULATION

S. P. Chaudhari, H. N. Dhende
Dr.D.Y.Patil College of Pharmacy, Akurdi, Pune, Savitribai Phule Pune University, Pune.

The aim of the current study was to extract the mucilage from Garden Cress (Lepidium Sativum Linn) seeds and to investigate the compressional behavior of mucilage in tablet formulation in comparison with standard binder such as starch using Heckel and Kawakita plot. Using paracetamol as model drug granules was prepared with different concentration (1%, 2%, and 3%) of the mucilage and starch by wet granulation method. The granules and tablets were evaluated for their flow properties, hardness, weight variation, thickness etc., and found to have hardness and disintegration time slightly more compared to starch as binder and hence satisfactory to prepare compressed tablets. The study revealed that the Lepidium sativum mucilage compared favourably with the standard starch as binder but plasticity of starch is more than Lepidium sativum mucilage as binder. 

 


6

FORMULATION AND EVALUATION OF HERBAL EMULGEL OF OCIMUM TENUIFLORUM AND MENTHA AREVENSIS LEAVES EXTRACT FOR ANTI-ACNE ACTIVITY

A. Susmitha, Dr. A. Seetha Devi
Department of Pharmaceutics, Hindu College of Pharmacy, Amaravathi Road,Guntur-522002, Andhra Pradesh, India.

Acne is a chronic inflammatory follicular disorder of the skin, occurring in specialized pilosebaceous units on the face. The lack of possible cure and associated disadvantages in allopathic medicines has led to extensive research in natural products with anti acne activity. Ocimum tenuifloram (tulasi) and Mentha arvensis (mint) were found to be efficacious and cost effective anti acne drugs with least side effects as compared to the synthetic drugs used in the treatment of acne. The present work is aimed to design and develop herbal anti acne topical drug delivery system of combined herbal drugs in the form of emulgel. The effect of emulgel is to be compared with the marketed preparation widely used for acne 


 


7

INCIDENCE OF POST DURAL PUNCTURE HEADACHE AMONG THE PATIENTS OF AGE 30 TO 70 YEARS UNDERGOING ORTHOPEDIC SURGERY UNDER SPINAL ANESTHESIA AT KHYBER TEACHING HOSPITAL, PESHAWAR, PAKISTAN

Asad khan*, Mati ullah, Hamaad
Institute of Paramedical Sciences (IPMS) a Constituent Institute of Khyber Medical university Peshawar, Pakistan.

Objectives of Study: The objectives of this study is to determine the incidence of post dural puncture headache among the patients of age 30 to 70 years and to determine the frequency at different age group of district Peshawar. Materials and Methods: The hospital based cross sectional study was conducted using convenience sampling technique. A total of 127 patients were randomly selected after taking written inform consent. The International Headache Society Criteria was used for diagnosing the PDPH. Any case with no contraindications to spinal anesthesia was included in the study, While all cases with contraindications to spinal anesthesia such as refusal, emergency, coagulopathy, infection, bleeding was excluded. Results: In the current study, the overall occurrence of PDPH was 18.9%. The female patients was more effected from PDPH which were 25% and 16.1 % male population was affected. Two groups were created 30-50 years and 51- 70 years in which the incidence was 20% and 17.3% respectively. Conclusion: CSF leaks was the most important factor in triggering the PDPH. In our study population the most needle gauges used were 22G, 24G, and 25G. If we use less diameter spinal needles, pencil point needles and avoid cutting point needles with the support of an experienced anesthetist. Due to applications of all these techniques we can decrease the incidence of PDPH. 


 


8

PCSK9 INHIBITORS: TO SOLVE OUT MANY CVS PROBLEMS

Arlin George*, Naveen S, Abdul Haseeb, Sunitha Mukuntha, Dr.Vineeth Chandy
T John College of Pharmacy.

Cardiovascular diseases are mostly due to unhealthy cholesterol rich diet. This becomes one of the most important cause of premature deaths. Cholesterol rich diet results in accumulation of this inside our body. There are HDL and LDL lipoproteins in body in which HDL is good cholesterol and the other is bad. So it is essential to lower the undesirable LDL. From the 1980s the most effective medicament prescribed for treating this dyslipidemic condition were statins. These drugs were most common and effective in lowering the LDL level. Worldwide, physicians still prefer statins as it has a very good and effective role in decreasing the LDL level. However it has some side effects like muscle pain, liver damage, increase in blood glucose level, muscle damage leading to rhabdomylosis, even various neurocognitive side effects etc. Recently a new therapy, PCSK9 inhibitors is brought out which is more efficient in the cholesterol lowering . Considering its safety profile which is more efficient than statins, can treat many cardiovascular patients efficiently. 


 


9

STUDY OF SOYA (GLYCINE MAX L. MERR.) ON MENOPAUSAL SYNDROME, AN EXTRA-PHARMACOPIEAL DRUG.

Dr. Shibani Dash*1, Dr. Siba Prasad Rout2
1Department of Stri Roga and Prasuti Tantra, All India Institute of Ayurveda, New Delhi, India.
2Department of Dravyaguna, KATS Ayurveda Collage.

Introduction: Menarche and menopause are the landmarks of the reproductive life of a woman. Menopausal syndrome is a transitional phase of imbalance of hormones by a varying degree of somatic and psychological changes. Due to increase in the life expectancy of female, the figures of menopausal women will be 103 million by 2026. Hormones replacement therapy, being the line of treatment of menopausal syndrome, also creating various drawbacks. Therefore, there is interest of some naturally occurring compounds with estrogenic properties, which is referred as phytoestrogens. Soya (Glycine max), being the richest source of phytoestrogen can be an alternative to the oestrogen replacement therapy for treating menopausal syndrome. This article aims upon the study of soya on menopausal syndrome with its pharmacological and pharmacodynamical action in details. Materials and methods: All the ayurvedic classics and modern text along with journals, electronic databases, PubMed, Cochrane, google scholar has been thoroughly searched. Result: As there is no direct reference of soya in ayurvedic classics, it belongs to the group of shimbi dhanya varga which is described in classics. The pharmaceutical and pharmacological action of soya related to the menopausal syndrome has been focused upon. Discussion and conclusion: As the stage of menopause implies upon hypo estrogenic Condition, so oestrogen is needed for the body in order to fulfil the level and supress the symptoms. Action of soya for the management of menopausal syndrome can be implemented due to the presence of phytoestrogens in terms of isoflavones in order to maintain the hormonal balance. 


 


10

PREVALENCE OF SECONDARY HYPERPARATHYROIDISM IN CHRONIC KIDNEY PATIENTS

Srichurnam Sreekar, Akhil Sunkari, Vedasamhitha Ramavarapu
Malla Reddy Institute of Pharmaceutical Sciences, Jawaharlal Nehru Technological University, Hyderabad, Telangana, India.

Secondary hyperaparathyoidism occurs mainly due to chronic kidney disease which aggravates from stage 1-5, which is due to imbalance between calcium and phosphorous homeostasis. Secondary hyperparathyroidism is the serious issue to be considered because of its complications including cardiovascular disease soft tissue and vascular calcification calcific uremic arteriolopathy (CUA). Our study was to find the prevalence of secondary hyperparathyroidism that would help to find out the epidemiological spread of the disease that would help in improving the treatment effectiveness for the safety of the subjects. our study includes 60 subjects who are undergoing dialysis from 12 to 48 months of duration we found high prevalence of secondary hyperparathyroidism with 66.6 % patients with IPTH levels over 300pg/ml, 83% of the patients were found to be hypocalcaemia and 75% of the patients were found to be having abnormal phosphorous levels with majority having high phosphorous levels so based on our study prevalence of secondary hyperparathyroidism was high which would results in serious complications like bone dystrophy which left untreated would result to death. The final result of our study include majority of the patient have secondary hyperparathyroidism which would results in further complications like bone dystrophy and cardiovascular abnormality left untreated would result in further menacing complications which left untreated would may lead to death of the patientsSecondary hyperaparathyoidism occurs mainly due to chronic kidney disease which aggravates from stage 1-5, which is due to imbalance between calcium and phosphorous homeostasis. Secondary hyperparathyroidism is the serious issue to be considered because of its complications including cardiovascular disease soft tissue and vascular calcification calcific uremic arteriolopathy (CUA). Our study was to find the prevalence of secondary hyperparathyroidism that would help to find out the epidemiological spread of the disease that would help in improving the treatment effectiveness for the safety of the subjects. our study includes 60 subjects who are undergoing dialysis from 12 to 48 months of duration we found high prevalence of secondary hyperparathyroidism with 66.6 % patients with IPTH levels over 300pg/ml, 83% of the patients were found to be hypocalcaemia and 75% of the patients were found to be having abnormal phosphorous levels with majority having high phosphorous levels so based on our study prevalence of secondary hyperparathyroidism was high which would results in serious complications like bone dystrophy which left untreated would result to death. The final result of our study include majority of the patient have secondary hyperparathyroidism which would results in further complications like bone dystrophy and cardiovascular abnormality left untreated would result in further menacing complications which left untreated would may lead to death of the patients. 




11

MANAGEMENT PROCESSES DURING DRUG DEVELOPMENT: A SPECIAL REPORT ON RESEARCH & DEVELOPMENT IN CRO’S AND PHARMACEUTICAL COMPANIES

Amol B. Garde*, Dipali Jagtap, Ashish S. Pagariya
Sinhgad Institute of Pharmaceutical Sciences, Lonavala, Maharashtra.

The most successful new drug-development programs require competent, caring, people-oriented leaders at all levels. Overwhelming social science data show that this approach will optimize productivity, efficiency, and creativity, while fostering employee growth, enthusiasm, cooperation, and loyalty. Companies are organized differently; for example, the various engineering responsibilities may be in one or more departments. A brief description of typical functions follows: _ Synthetic chemistry synthesizes NCE candidates for pharmacological testing. _ Pharmacology examines the in vivo activity of the NCE in animals. Other involved departments/disciplines that are equally important as the above groups include Analytical Chemistry, Biochemistry, Biopharmaceutics/ Pharmacokinetics/Drug Metabolism, Chemical Pilot Plant, Experimental Engineering, Packaging Development, and Statistics. Additional significant contributors include Purchasing and Quality Assurance/ Documentation. 


 


12

ANTIBIOTIC BEAD POUCHES IN OPEN FRACTURES: ELUTION OF ANTIBIOTICS FROM PMMA BEAD POUCHES IN OPEN FRACTURES

Dr S Amarnath M.S*, K Bindu Madhuri, L Tejaswi, A Chetanya Brahma, Dr Shaik Faizan Ali
Amar Orthopedic Hospital, Department of Pharmacy Practice, Hindu college of Pharmacy, Guntur.

The increasing incidence of open fractures has led to higher infection rates leading to higher incidence of non-union and morbidity. Antibiotic impregnated PMMA (polymethyl methacrlyte) bone cement, (in the form of bead pouch) is used to deliver higher concentrations of local antibiotics to prevent bone infection in open fractures. This study demonstrates the effectiveness of combination antibiotic impregnated bone cement in infected open fractures. This study shows that local antibiotic elution through antibiotic impregnated bone cement is more potent and helps in controlling the infection. Combination antibiotics added to bone cement are more effective against a wide spectrum of bacteria than single antibiotic (gentamicin as provided by manufacturer). 


 


13

DEVELOPMENT AND EVALUATION OF NANOEMULSION FOR IMPROVED ORAL DELIVERY OF LURASIDONE HYDROCHLORIDE.

B. Kusum*1, R. Shyamsunder2
1Department of Pharmacy, University college of Technology, Osmania University, Telangana, INDIA.
2Head and Principal, University college of Technology, Osmania University, Telangana, INDIA.

Low aqueous solubility is a major problem faced during the formulation of NCE, Lurasidone Hydrochloride is an antipsychotic agent specially used in the treatment of schizophrenia. Lurasidone is practically insoluble in purified water, has poor bioavailability and slow onset of action. The purpose of the present study is to enhance the solubility and bioavailability of Lurasidone hydrochloride by Nanoemulsion technique. Different solubility studies were performed and the Nanoemulsion were prepared by using isopropyl myristate, Oleic acid, Capryol 90 Propylene glycol dicaprate as oil phase and selected surfactants and Co- Surfactants were used to formulate the Nanoemulsion. The formed Nanoemulsion were evaluated for different test. Based on the invitro drug release studies it is concluded the increase in the dissolution profile of the Nanoemulsion when compared to the pure API, which implies the increase in bioavailability of Lurasidone Hydrochloride, by using Capryol 90 as the oil phase, Tween 80 was used as surfactant and PEG 400 used as co-surfactant. 


 


14

EFFECT OF LOW DOSE KETAMINE HYDROCHLORIDE ON TOURNIQUET INDUCED HYPERTENSION IN LOWER LIMB SURGERIES

Dr. Srishti Meghare, Dr.Kinna Shah, Dr. Bhavana Shah
Anesthesia Department, G C R I, Ahmedabad, Gujarat.

Aim:-There is a constant increase in hemodynamic parameters during prolonged tourniquet inflation .We had investigated the effect of low dose 0.5mg/kg bolus ketamine on hemodynamic changes during tourniquet application in lower limb orthopaedic surgeries under general Anesthesia. Method:-100 patients posted for lower limb surgeries under standard general anesthesia using tourniquet were randomly assigned to one of two groups in double blind study. The Group C (control group) received 10 ml saline IV and Group K (study group) received 0.5mg/kg diluted in 10ml 0.9% saline IV given 10 minutes before tourniquet inflation. We had recorded hemodynamic changes, EtCO2 and Et Sevoflurane at 5 minutes interval up to 20 minutes of tourniquet deflation. Inj. Fentanyl 1mcg/kg supplemented if Systolic BP or heart rate raised more than 30% of base line. Results: - Hemodynamic stability was seen statically significant in Group K (p value, < 0.05) at 40, 50 and 60 minutes. Less number of patients needed supplemental fentanyl intra operatively in Group K than in Group C (3 V/s.18 p value <0.05). Conclusion: - Low dose bolus Ketamine 0.5mg/kg prevents tourniquet induced hypertension in lower limb surgery done under general anesthesia. 


 


15

REVIEW ON VAGINAL DRUG DELIVERY SYSTEM

Manikanta Kumar. Y.S.S
GITAM Institute of Pharmacy, GITAM (Deemed to be University), Rushikonda, Visakhapatnam-530045, Andhra Pradesh.

Many efforts have been made for drug administration through alternative routes after the poor absorption of drugs through oral route. Then the vaginal drug delivery system has been rediscovered for drug absorption. This system has been known and followed from the ancient times. This is the best route and has the potential for the administration of proteins, peptides and many other therapeutic drugs like macro-molecules. For the administration of drug like contraceptives, steroids, metronidazole and anti-retroviral, vaginal drug delivery is the most optimal and favorable route. Hepatic - gastrointestinal first-pass metabolism, gastric impatience of drugs and vacillation of dosing interval possibilities can be prevented by the continuous infusion of drugs through vaginal mucosa. The rate and effect of drug absorption through vaginal route depends on the physiology of vagina, stages of menstrual cycle, age, pathological conditions, health conditions and formulation factors. Various dosage forms like suppositories, gels, creams, ointments, foams, vaginal rings are used in vaginal drug delivery system. The benefits of vaginal drug delivery system are it increases the bioavailability, least systemic side effects; easiness of use and self-medication is possible. However vaginal drug delivery system is considered as a less effective route because of the unfortunate absorption of drugs across the vaginal epithelium. This review gives an explanation of vaginal physiology, drug absorption through vagina, advantages and disadvantages and many other features of vaginal drug delivery systems and its pharmaceutical aspects