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University Institute Of Pharmacy,
Chhatrapati Shahu Ji Maharaj University, Kanpur
Non-ionic surfactant vesicles (Niosomes or NSVS) are widely studied as an alternative to hydrated surfactant monomers. Non-ionic surfactants of wide structural types have been found to be useful alternatives to phospholipids in fabrication of vesicular system. They are the microlamellar structures formed by the mixing of Non-ionic surfactant of alkyl or dialkyl polyglycerol ether class and cholesterol with subsequent hydration in aqueous media. This review article deals with the detailed use of Niosome as novel drug delivery system for ophthalmic use, since this route is most frequently used for the treatment of eye infection.
Jitendra Kumar Badjatya
Montajat Pharmaceutical Company Limited, Dammam, KSA
A Generic Product must meet the standards established by China Food and Drug Administration (CFDA) to be approved for marketing in China respectively. This study covers the introduction to generic drugs, in China regulatory authorities. It also includes the requirements and registration of Generic Drugs.
Many large pharmaceutical companies have increased their presence in emerging markets in recent years like China markets is predicted to be the second largest market after US in Pharmaceuticals. China is moving past its phase as a supply market for ingredients and generic finished drugs. So, is more important to know about Regulatory considerations and Registration process of Generic Drugs. This article focuses in particular on pharmaceuticals companies, the Registration process of Generic Drugs, and their activities in the China.
FORMULATION AND EVALUATION OF GASTRORETENTIVE HYDROCHLOROTHIAZIDE FLOATING MICROSPHERES: STATISTICAL ANALYSIS
Y. Veda Pravallika* , K.Rajyalakshmi
Bapatla college of pharmacy,
Bapatla, Andhra Pradesh
The main objective of this work is to formulate gastroretentive floating microspheres of hydrochlorothiazide and to study the effect of formulation variables like drug to polymer ratio and concentration of polymer dispersion. The hydrochlorothiazide floating microspheres were formulated by using orifice-ionic gelation technique. These microspheres were formulated by using sodium alginate as sustained release polymer, sodium bicarbonate as gas generating agent and calcium chloride as a cross linking agent. The rheological properties of the polymer dispersion were studied. The microspheres were formulated by different drug to polymer ratio’s at various concentrations of sodium alginate dispersion. Thus formulated microspheres were evaluated for floating behaviour, drug entrapment efficiency, drug content, micromeritic properties, particle size, swelling index, invitro drug release studies and release kinetics. The better formulation was subjected for stability studies and SEM analysis. The effect of formulation variables on the entrapment efficiency and release rate constant was studied by statistical analysis. The hydrochlorothiazide microspheres formulated with 1:3 drug to polymer ratio and 3.5% sodium alginate dispersion concentration was selected as optimized formulation based on the results.
Ankit J. Joshi
Department of Pharmaceutics & Pharmaceutical Technology,
S. K. Patel College of Pharmaceutical Education and Research,
Ganpat University, Ganpat vidyanagar, Kherva, Mehsana-Gozaria Highway, Gujarat.
The preservation of cells, tissues and organs by cryopreservation is promising technology now days and Low temperature technology has progressed in the field of tissue engineering, food preservation, fertility preservation, making disease resistant breeds since the early years to occupy a central role in this technology. Cryopreservation is important technology in every field like in organ cryopreservation, food cryopreservation, human cryopreservation, seeds cryopreservation, protein cryopreservation and pharmaceuticals. Cryobiologists will be required to collaborate with new physical and molecular sciences to meet this challenge. How cryoprotectants work is a mystery to most people. In fact, how they work was even a mystery to science until just a few decades ago. This article will explain in basic terms how cryoprotectants protect cells from damage caused by ice crystals, and with some of the advances.
Firake Bhushan M.1, Pandagale Sagar J.2, Firke Sandip D.3, Palshikar Gautam S.4
1Department of Pharmaceutical Chemistry, JSPM’s Jayawantrao Sawant College of Pharmacy and Research, Hadapsar, Pune
2Department of Pharmaceutical Analysis, JSPM’s Jayawantrao Sawant College of Pharmacy and Research, Hadapsar, Pune
3Department of Pharmaceutical Chemistry, SES’s R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur
4Department of Pharmacognosy, JSPM’s Jayawantrao Sawant College of Pharmacy and Research, Hadapsar, Pune
Epilepsy is one of the most serious disorders of the brain, affecting about 50 million people worldwide. Epilepsy leads to multiple interacting medical, psychological, economic and social consequences. Successful seizure control is very important in decreasing the psychosocial and economic costs of epilepsy. Yet, most therapies didn’t completely improve patients for numerous reasons. The most effective antiepileptic drugs (AEDs) include phenytoin, carbamazepine, valproic acid, phenobarbital, and primidone. Of the older AEDs, carbamazepine and valproic acid together bring a threat of hepatic toxicity and have been associated with fetal anomalies. Carbamazepine and phenytoin aggravate hypersensitivity reactions in a significant number of patients, and phenytoin is associated with chronic adverse events (AEs). Phenytoin, carbamazepine, phenobarbital, and primidone are hepatic enzyme inducers. Valproic acid, on the contrary, is a powerful hepatic inhibitor.
The newer agents have fewer drug interactions and slight, if at all, effect on the CYP450 enzyme system and other metabolic pathways. One of these new agents was gabapentin (GBP). GBP, the new antiepileptic drug (AED) has a broad spectrum of anti-seizure effects, less adverse effects and less drug interaction. GBP has since achieved international acknowledgment, not for its antiepileptic properties, but also its effectiveness in the managing of acute and chronic pain syndromes, especially neuropathic pain. It is prescribed as an add-on medication for the treatment of patients aged >12 years with partial and secondary generalized tonic-clonic seizures and for children aged 3 to 12 years with partial seizures. It has been used for monotherapy in adults in 38 countries. Gabapentin is regarded as safe and tolerable with a promising pharmacokinetic profile and an extensive therapeutic index.
The present article reviews the available information that dealing with the long-standing efficiency and safety of gabapentin in the treatment of patients with epilepsy.
Manager – Quality Assurance
[The author is a Quality Assurance professional of a leading MNC]
DI issues – a cause or effect
“It is only the laboratory where such issues were noted, otherwise, we were good at everything”- heard almost after every USFDA inspection once a 483 or warning letter has been issued. It’s been always the laboratories accused of objectionable GMP findings specifically related to data integrity issues.
The question that remains unanswered is why would someone from one department of a big organization be so unethical, so unprofessional that they tend to cause such damages to their own organization who they receive salaries from? In fact, they had to work hard to earn this job! Neither are the lab professionals happy to have damaged organizational reputations. We perhaps may need to rethink whether we are blaming the corners for holding dust of a big room. It might turn out that we start realizing integrity issues are actually the consequence of an organizational deficiency and a reflection of an operational integrity; it has less to do with data and more to do with integrity. Data integrity non-compliance therefore is not the cause but a real effect.
STUDY OF EFFECT OF SUPPLEMENTATION OF ZINGIBER OFFICINALE ON PHARMACOKINETIC PROFILE OF SITAGLIPTIN PHOSPHATE ON STREPTOZOTOCIN INDUCED TYPE II DM RAT MODEL
Swati R. Dhande, Aruhana R. Patil*, Lilasrao J. Kadam
Bharati Vidyapeeth's College of Pharmacy,
Belapur, Navi Mumbai
Diabetes Mellitus (DM) is a metabolic endocrine disorder. It is one of the most rapidly growing diseases worldwide. Various pharmacotherapies have been practiced in the cure and management of DM. The existing conventional therapies aims at reducing hyperglycemia and achieving better glycemic control over the time, but fail to combat the other risk factors associated with the disease. The newer approaches are targeting to combat the risk factors and reduce the progression of disease. The newer approaches includes regenerational therapies, use of herbal and natural supplements, use of antioxidants and use combinations of conventional therapies with above mentioned therapies. Though these combinations have been found to be promising in the management of DM, the risk of pharmacological interactions cannot be overlooked. The present study was conducted to evaluate the pharmacokinetic interaction between DPP-IV inhibitor sitagliptin and a nutraceutical Z. officinale. STZ (Streptozotocin) and HFD (High Fat Diet) induced Type II DM rat model was used and the possible interaction was determined. The evaluation was done on validated HPTLC bioanalytical method. The present combination of sitagliptin and ginger did not affect the pharmacokinetic profile of sitagliptin.
Chaudhary Sonam*, Rathore KS
Bhupal Noble’s Institute of Pharmaceutical Sciences,
Sewashram road, Udaipur, Rajasthan, India
A new approach to drug development could increase efficiencies, provide regulatory relief, flexibility, and offer important business benefits throughout the product’s life cycle. Quality by design is a systemic approach and essential part of the modern approach for quality and pharmaceutical development.
It includes defining target product quality profile, designing product, developing formulations, manufacturing processes, identifying critical quality attributes, process parameters, sources of variability and controlling manufacturing processes to ensure consistent product quality over time.
Pharmaceutical quality can be assured by understanding, controlling formulation and manufacturing variables using Quality by design. Product quality can be confirmed by product testing. Pharmaceutical industry have to work hard to develop, manufacture, to bring new drugs to market, to comply with regulatory requirements to ensure that the drugs are safe and effective. Implementation of Quality by design leads to transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.
Vivek P. Chavda*, Moinuddin M. Soniwala
Department of Pharmaceutics,
B.K. Mody Government Pharmacy College, (Affiliated to Gujarat Technological University)
Rajkot – 360003, Gujarat (India)
The aim of this study was to investigate and evaluation of delayed release enteric coated paracetamol tablets. Successful delivery of drugs specifically to the intestine requires the protection of drug from being released in stomach. PCM core tablets were prepared with and without superdisintigrant using wet granulation method. Dip coating method is used for coating were different concentration of Eudragit L100 is used as coating agent. Preformulation studies like angle of repose, bulk density, tapped density, porosity, Carr's index, Hausner's ratio were performed. The FDT2 batch shows the highest drug release at end of total 135 min of 94.13 % which are the satisfactorily promising results. So, we can conclude that the FDT2 is the optimized batch among all three batches. From the reproducible results obtained from the executed experiments it can be concluded that Eudragit L 100 can be used as enteric coated polymer. These results reflect that PCM can be successfully enteric coated in order to prevent its release in the stomach and facilitate rapid release of the drug in the duodenum, due to the presence of superdisintegrant. Formulating these enteric coated tablets could increase patient compliance by decreasing adverse drug reactions (ADRS) associated with PCM therapy.
Department of Pharmaceutics,
St.Pauls College of Pharmacy, Turkayamjal (V),
Hayathnagar (M), R.R.Dist-501510, India.
Objective: Cefixime is a third generation cephalosporin antibiotic having bactericidal activity by inhibition of cell wall synthesis and is used in the treatment of uncomplicated UTI, pharyngitis and tonsillitis, acute bronchitis and acute exacerbation of chronic bronchitis, uncomplicated gonorrhoea etc. The concept of formulating floating tablets containing Cefixime offers a suitable and practical approach in serving desired objective of retaining the drug in the stomach to increase the its bioavailability.
Methods: The tablets were prepared by direct compression methodand total of 12 formulations are developedemploying HPMC K100M and HPMC K15M as polymers for sustaining the drug release and sodium bicarbonate as the gas generating agent.
Results: Various polymers have been selected and subjected to IR-spectroscopic studies and found that there were no drug–excipient interactions. The powder blends of all the formulations have shown good flow properties. Other parameters such as hardness, friability, drug content uniformity, Floating lag time and in-vitro dissolution studies were performed and the results were satisfactory.
Conclusion: Formulation F 12 was found to be best in all aspects and was considered as optimized formulation, it has a low floating lag time of 2mins and has shown a maximum drug release of 99% at the end of 24 hours and drug release was by diffusion through the polymer matrix.