1. | FORMULATION AND EVALUATION OF ORAL DISINTEGRATING NIMODEPINE TABLETS |
| Krupa Devi S*, Umasankar K, Jayachandra Reddy P |
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More than 50% of pharmaceutical products are orally administered for several reasons. This route of administration is considered as the most widely used route as it offers advantages like ease of administration, versatility, patient compliance and accurate dosing. Undesirable taste is one of the important formulation problems that are encountered with such oral products. Difficulty in swallowing is also a common problem of all groups, especially the elderly and pediatrics, because of physiological changes associated with these groups. Taste of a pharmaceutical product is an important parameter governing compliance. Hence taste masking of oral pharmaceutical has become important tool to improve patient compliance and the quality of treatment especially in pediatrics. Hence formulation of taste masked products is a challenge to the pharmacist. KEY WORDS: Nimodepine, Oral disintegrating Tablets, Direct compression.
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2. | EVALUATION OF NSAID MEDICINE HANDLING MOTIF UTILIZING WHO BAROMETER AND PREVALENCE STUDY AT A RESEARCH AND HEALTH CARE CENTER IN CHENNAI |
| Aleem sarwar* , Badrud duza M , Bandakrinda Sireesha , Lakshmi Raj Sulochana |
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Drug classes that reduce pain are the greatest and broadly recommended medicines and mostly using in the physical suffering, such as high temperature of the body as a fever and irritate infection. Globally, accomplished 6.8 crores drugs prescribed of non-steroidal anti inflammatory drugs each year, and nearby 2.9 crores inhabitants are using non-steroidal anti inflammatory every day. Aim and objective: To study and evaluation of NSAID medicine handling motif utilizing who barometer and prevalence study at a research and health care center of Chennai. To study the detection and understanding of drugs assessment and motif of NSAIDs in the triennial health care center Chennai, Tamil Nadu, and India. Methods and materials: Retrospective study were followed in this study of 90 days time duration of this study that was 15 April 2017 – 15 July 2017, at the OP departments of triennial health center Chennai, Tamil Nadu, India, following in position and achieved the doctrine consciences authorization. World health organization written communication in which way or manner evaluating the medicines administered for wellness required ability. Prescriptions to involve as a 500 recommendations into the retrospective observation. Result: All 500 illnesses were consulted, in addition outpatients department recommended medicines are abandoned and utilized as a basis on sign illustrated in table 1. Here is 500 recommended medicines, non steroidal anti inflammatory drugs are given in 140 dispensary window (25.42%). Unselective Cyclooxygenase blockage was the general recommended of medicine, along the superior repetitiveness of P. mol (paracetamol) (36.02%) pursued through Aceclofenac, ibuprofen, and Aceclofenac. Discussion: In this study the recommended experience of non steroidal anti inflammatory drugs into this research signed few fluctuation and against of world health organization approved. And normal and typical unit of the mathematical system of medicines as particular recommended drugs into this research, 2.21 (sphere 2-6 medicines recommendations), and this is unacceptable as well as comparison to approved (2.1- 2.3) derivative as model perfection. Conclusion: The drugs recommendations experiences about non steroidal anti inflammatory drugs signing few changes according to world health organization guideline. In this information and data capture becoming a beneficial to work setting for additional and for further study work to develop the recommending drugs experiences in the targeted point. KEY WORDS: NSAIDs, FDCs, national list of essential medicine.
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3. | REGULATORY REQUIREMENTS FOR MARKETING AUTHOURIZATION OF GENERIC DRUGS AND COMPILATION OF DOSSIER FOR EUROPEAN MARKET IN CENTRALIZED PROCESS |
| Senagala Kullayappa, Shilpaja C, Jayachandra Reddy P |
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The EU has one of the most highly regarded regulatory systems in the world. The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralized marketing authorization applications (MAA). Once granted by the European Commission, the centralized marketing authorization is valid in all European Union (EU) Member States. The system comprises of European parliament, the council of ministers, and the European Commission. EU consists of 27 member states: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom and three countries which are member of European. Free Trade Agreement (EFTA) Iceland, Norway, and Liechtenstein. These EFTA members are those countries which were unable to join rest of the 27 member states as common market. These three EFTA member countries along with 27 EU member states. KEY WORDS: European market, Regulatory requirements, Generic drugs.
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4. | REGISTRATION REQUIREMENTS OF GENERIC DRUGS USED IN THE TREATMENT OF LIFE STYLE DISEASES IN ASEAN COUNTRIES |
| Banam Ramesh*, Jyothshna Devi K, Jayachandra Reddy P |
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The pharmaceutical manufacturer needs to incorporate the technical requirements and all other documents of new pharmaceuticals to market their products in other countries. In this presentation it is individually discussed about the rules and regulations which are followed for drug approval process in U.S.A and Canada Any product should reach the criteria of the individual country guidelines. This study mainly discusses “Dossier preparation of generic solid orals in U.S and Canada”. By following the guidance and regulations of USFDA, Health Canada, ICH and WHO filing process of pharmaceuticals in US and Canada countries will become very easy and accurate. Compilation in eCTD module will be helpful in reviewing of dossier in a very short time. In this competitive world of pharma generics, an attempt is made to highlight the difference between the two major countries registration requirements through CTD format. KEY WORDS: Life Style Disease, Regulatory requirements, Generic drugs.
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5. | FORMULATION AND EVALUATION OF SILDENAFIL CITRATE MOUTH DISSOLVING TABLET |
| Dr. Sivanageswararao Mekala, Dr. Salum Seif Salum Mchenga, Dr.Arul Amuthan,Dr. Saravanan R |
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Mouth dissolving tablets are best suited and have gained popularity in recent years in oral drug therapy. These tablets disintegrate instantaneously when put on tongue, releasing the drug that dissolve or disperses in saliva. Some drugs are absorbed from the mouth, pharynx and oesophagus as the saliva passes down into the stomach. In such cases; bioavailability of drug is significantly greater than those observed from conventional tablet dosage form. The major criteria for the mouth dissolving tablet is to disintegrate or dissolve rapidly in oral cavity with saliva in 15 seconds to 60 seconds, without need of water and should have pleasant mouth feel. It has been reported that sildenafil citrate possess bitter taste hence primary objective is to mask the bitter taste and further developing the drug into mouth dissolving tablets. Bitter taste of sildenafil citrate is masked with addition of sodium bicarbonate which decrease the solubility of sildenafil citrate in mouth, further mild effervescent reaction between dry acid (Citric acid) and dry base (sodium bicarbonate) favour both faster disintegration and pleasant mouth feel. Direct compression was used as it required conventional tablets machinery and thus is an economical process. The tablets produced were evaluated for thickness, hardness, friability, weight variation, disintegration test, wetting time. The dissolution data were treated to check dissolution efficiency and dissolution rate. Based on the result it was concluded that formulation with 8% disintegrating agent (4% in mannitol granules and 4% in agglomerated disintegrate granules) show better disintegration and dissolution profile.
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6. | DETERMINATION OF ANTI-DIARRHOEAL ACTIVITY OF VETIVER |
| D Pranitha*, Ganesh Kumar Y, D Phaneendra Pavan, Ch. Madhava Reddy |
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Diarrhea is the most common disease of bowel movement which is originated from contaminated food and waterin developing countries. It is also caused by bacteria, viral infections and parasitic organism. The antibiotic resistanceused for bacteria clostridium difficile shows higher incidence of diarrhea. The astringent activity, anti inflammatorycomponents and bulk forming agents are involved in the plants used in the diarrheal treatment. The seeds are potential toimportant substantial medicines. Herbal medications plays an important role in india. The present study was conductedwith various folklore claims in the plant Vetiver zizinaloides to isolate saponins and ethanol is extracted from the fruits.The ethanolic extract of Vetiver zizinaloides may be useful in a wide range of diarrhoeal states, due to both disorders oftransit e.g. functional diarrhoeas, radiation diarrhoea or due to abnormal secretory mechanisms like in cholera or E.colienterotoxin induced diarrhoea. Further studies are needed to completely understand the mechanism of anti-diarrhoealaction of Vetiver zizinaloides
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7. | A STUDY ON ASD (AUTISM SPECTRUM DISORDER) DIAGNOSIS
CHALLENGES: REFERRAL PATTERNS & PARENTAL IMPACT |
| Dr. Rakesh Kumar |
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Diagnosing Autism Spectrum Disorder (ASD) often involves a prolonged process, particularly due to the lack of
diagnostic tools in primary healthcare settings. In a case-control study involving 98 children, both with and without ASD,
the study compared complaints and referral patterns. Autistic children tended to exhibit crying episodes and feeding
difficulties more frequently than their counterparts without ASD. Moreover, patients commonly sought assistance from
their general practitioners due to anxiety, enuresis, and sleep disturbances. Referrals for procedures such as
tympanostomies and tonsillectomies were often initiated by physiotherapists and speech therapists. Additionally, the study
observed a notable correlation between the condition of children with ASD and depression in their parents
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