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Pharmaceutics Articles


GABAPENTIN: A NEW BROAD SPECTRUM ANTIEPILEPTIC DRUG

ABOUT AUTHORS:
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
bmf.jscopr@gmail.com

ABSTRACT:
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.


DATA INTEGRITY NON-COMPLIANCES – THE GOOD, BAD AND UGLY

ABOUT AUTHORS
Krishnendu Singha
Manager – Quality Assurance
[The author is a Quality Assurance professional of a leading MNC]
Krish_singha2007@yahoo.co.in

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

ABOUT AUTHORS:
Swati R. Dhande, Aruhana R. Patil*, Lilasrao J. Kadam
Bharati Vidyapeeth's College of Pharmacy,
Belapur, Navi Mumbai
*arpatil1991@gmail.com

ABSTRACT
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.


FORMULATION DEVELOPMENT AND EVALUATION OF DELAYED RELEASE ENTERIC COATED PARACETAMOL TABLETS

ABOUT AUTHORS:
Vivek P. Chavda*, Moinuddin M. Soniwala
Department of Pharmaceutics,
B.K. Mody Government Pharmacy College, (Affiliated to Gujarat Technological University)
Rajkot – 360003, Gujarat (India)
*vivek7chavda@gmail.com

ABSTRACT:
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.


A REVIEW ARTICLE: PRONIOSOMES

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ABOUT AUTHORS:
Shweta Vashist*, Jyoti Kaushik, Batra K. Sunil
Department of Pharmaceutics,
Hindu College of Pharmacy, Sonipat
shwetavashist55@gmail.com

ABSTRACT:
Skin is the main target of topical and transdermal preparations. Major aim of transdermal drug delivery sytem is to cross the stratum corneum. Now-a-days we better know vesicles have importance in cellular communication. Niosomal carrier are systems containing soft vesicles, composed of non –ionic surfactant and an alternative to liposomes. They can entrap both hydrophilic and hydrophobic chemicals but these types of vesicles include the superior physical stability problems such as aggregation, fusion, and leakage of encapsulated drug. Proniosomes are provesicular approach which overcomes the limitations of vesicular system (Niosomes). Provesicular approach has been proposed to enhance the stability of vesicles. Proniosomes is a compact semi-solid liquid crystalline product of non- ionic surfactant  easily formed on dissolving the surfactant in minimal amount of acceptable solvent and the least amount of aqueous phase. Proniosomes can be converted into niosomes in –situ by absorbing water from the skin.


ENHANCEMENT OF SOLUBILITY AND DISSOLUTION RATE OF SIMVASTATIN BY TERNARY SOLID DISPERSION TECHNIQUE

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ABOUT AUTHORS:
Shete Reshma S.1*, Gadhave Manoj V.2, Gaikwad D. D.3
1Department of Quality Assurance Techniques,
2Department of Pharmaceutics,
3Department of Pharmaceutics,
VJSM’S Vishal institute of pharmaceutical education and research, Ale, Pune, Maharashtra, 412411
*reshma.s.shete@gmail.com

ABSTRCT
Simvastatin is a poorly soluble drug exhibiting poor dissolution pattern. Simvastatin, PEG 6000 & Poloxamer 407 solid dispersions were prepared with a view to study the influence of polymer on solubility and dissolution of this poorly soluble drug Simvastatin. Solid dispersions of Simvastatin were prepared using different ratios of PEG 6000 & Poloxamer 407 as carrier by, solvent evaporation method. They were evaluated for percentage yield, drug content, FTIR spectral studies, DSC, XRD, solubility, and in-vitro dissolution. The solubility profile indicated that there is increase in solubility of Simvastatin when polymer concentration is increased. The solid dispersion complex of drug (1:5:5 ratios) was giving better dissolution profile as compared to pure drug and other solid dispersions. This in turn can improve the bioavailability. FT-IR, DSC shows the compatibility of drug and carrier.


DISSOLUTION METHOD DEVOLOPMENT OF FLUCONAZOLE IN FLUCONAZOLE TABLETS DOSSAGE FORM

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ABOUT AUTHORS:
Auti Snehal D.*1, Jadhav S. L2, Gadhave Manoj V3
1Department of Quality Assurance Techniques
2,3Department of Pharmaceutics
VJSM’S Vishal institute of pharmaceutical education and research, Ale, Pune, Maharashtra, 412411
snehal.d.auti@gmail.com

ABSTRACT:
The present research work discusses the development of a dissolution method for Fluconazole using UV spectrophotometer. Simple, accurate and cost efficient dissolution method has been developed for the estimation of Fluconazole in bulk and tablet dosage form. The optimum conditions for the dissolution of the drug were established. The dissolution media was found to be 0.1N HCl (pH 1.2). The apparatus was found to be USP II, Paddle and the speed was found to be 50 rpm for 30 minutes time interval.


DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC ESTIMATION OF DICLOFENAC SODIUM BULK AND TABLET DOSAGE FORM USING AREA UNDER CURVE METHOD

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ABOUT AUTHORS:
Mali Audumbar Digambar*, Jadhav Santosh, Mane Pandurang, Tamboli Ashpak
Department of Pharmaceutics, Sahyadri College of Pharmacy, Methwade,
Sangola- 413307, Solapur, Maharashtra, India
maliaudu442@gmail.com

ABSTRACT
A simple, precise, accurate and economical UV visible spectrophotometric method has  been developed for estimation of Diclofenac sodium drug by AUC method. The standard and  sample solutions were prepared by using double distilled water as a solvent. Quantitative determination of the drug was performed at wavelength range 270-282 nm. The linearity was established over the concentration range of 05,10,15,20&25µg/ml for Diclofenac sodium with correlation coefficient value of 0.9981. Precision studies showed that % relative standard  deviation was within range of acceptable limits. The mean percentage recovery was found to be 99.38%.The proposed method has been validated as per ICH guidelines.


TARGETED DRUG DELIVERY SYSTEMS FOR LUNG CANCER

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ABOUT AUTHORS:
Abdul Waheed1*, Ankit Gupta2, Parth Patel3
1Department of Pharmacology
2Department of Pharmaceutics
3Department of Drug Regulatory Affair
Amity Institute of Pharmacy, Amity University, Noida-125, U.P. (INDIA)
abdul.waheed2050@gmail.com

ABSTRACT
In the present scenario, lung cancer is one of the most prevalent and malignant cancer especially among the smoking group of people. The targeted delivery of chemotherapeutic agents to the lungs represents a novel therapeutic approach in lung cancer. Lung is an ideal route for administration of anticancer drug as it provides larger alveolar surface area, low thickness of epithelial barrier & extensive vascularization. Nanoparticles with nanocarriers have possibility of cell-targeted drug delivery with minimal systemic side effect and toxicity. Pulmonary epithelial cell, enzymes, receptors and genes are the target of the targeted drug delivery in lung cancer. This paper reviews the till date targeted drug delivery research performed for the treatment of lung cancer.


DIFFERENCE SPECTROSCOPIC METHOD FOR THE ESTIMATION OF ACEBUTOLOL HYDROCHLORIDE IN BULK AND IN ITS FORMULATION

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ABOUT AUTHORS:
Jadhav Santosh*, Mali Audumbar, Pawar Seemarani, Kharat Rekha, Tamboli Ashpak
Department of Pharmaceutics, Sahyadri College of Pharmacy, Methwade,
Sangola-413307, Solapur, Maharashtra, India.
*jadhavsan88@gmail.com

ABSTRACT:
A simple, precise and accurate difference spectroscopic method has been developed for the estimation of Acebutolol Hydrochloride in bulk drug form by difference spectrophotometric method. Acebutolol Hydrochloride has exhibited maximum absorbance at about 233nm and 234nm in acidic and basic solution respectively. Beer’s law was obeyed in the concentration range of 2-10 µg/ml in both the cases. The regression of coefficient was found to be r2=0.9992. The LOD and LOQ value were found to be 0.2670ppm and 0.8091ppm respectively. The proposed method was successfully applied for the determination of Acebutolol Hydrochloride in bulk drug. As per ICH guidelines the result of the analysis were validated statistically and were found to be satisfactory.


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