Pharmaceutics Articles

GABAPENTIN: A NEW BROAD SPECTRUM ANTIEPILEPTIC DRUG

{ DOWNLOAD AS PDF }

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

{ DOWNLOAD AS PDF }

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.


QUALITY BY DESIGN

{ DOWNLOAD AS PDF }

ABOUT AUTHORS:
Chaudhary Sonam*, Rathore KS
Department of Pharmaceutics,
Bhupal Noble’s Institute of Pharmaceutical Sciences,
Sewashram road, Udaipur, Rajasthan, India
*chaudharysonam1993@gmail.com

ABSTRACT
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.


FORMULATION DEVELOPMENT AND EVALUATION OF DELAYED RELEASE ENTERIC COATED PARACETAMOL TABLETS

{ DOWNLOAD AS PDF }

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.


FORMULATION DEVELOPMENT AND IN-VITRO EVALUATION OF FLOATING TABLETS OF CEFIXIME

{ DOWNLOAD AS PDF }

ABOUT AUTHORS:
B.Venkateswara Reddy
Department of Pharmaceutics,
St.Pauls College of Pharmacy, Turkayamjal (V),
Hayathnagar (M), R.R.Dist-501510, India.
basu.pharmacist@gmail.com

ABSTRACT:
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.


TAILOR-MADE MEDICINE: A STEP TOWARDS FUTURE OF DIAGNOSTICS AND THERAPEUTICS

{ DOWNLOAD AS PDF }

ABOUT AUTHORS
Vivek P. Chavda
Department of Pharmaceutics,
B.K. Mody Government Pharmacy College, Near Aji dem, Rajkot-Bhavnagar highway,
Gujarat technological university, Rajkot-360003, Gujarat (India)
vivek7chavda@gmail.com

ABSTRACT
The goal of tailor-made medicineis to maximize the likelihood of therapeutic efficacy and to minimize the risk of drug toxicity for an individual patient. It involves right drug & dose, right patient and at right time administration of a medication. By averting the knowledge of gene sequence and their functions, biomedical research are diversified towards inter-individual variations that are expected to become an eminent part of treatment planning in terms of efficacy and toxic side effects of drugs. tailor-made medicinefocuses on individualized drug treatment according to each patient’s molecular diagnosis and genetic makeup. Genomic-based diagnostics can play a key role in creating a more efficient healthcare system by directing patients toward beneficial therapies and away from therapies that pose substantial risk or are unlikely to improve outcomes for the patient.


FORMULATION AND PRODUCT DEVLOPMENT OF PRESSURISED METERED DOSE INHALER: AN OVERVIEW

{ DOWNLOAD AS PDF }

ABOUT AUTHORS:
*S R Thorat1, S M Meshram2
1Lupin Research Park, Hinjewadi, Pune, Maharashtra
2TATA Consultancy Services, Hinjewadi, Pune, Maharashtra
santoshthorat345@gmail.com

ABSTRACT
Pressurized metered dose inhalers (MDIs) are widely used dosage form for treatment of respiratory diseases, such as asthma and chronic obstructive pulmonary disease. The metered dose inhaler (MDI) contains the active pharmaceutical ingredient dispersed or solubilised in a high vapour pressure propellant and metered accurately in tens to hundreds of micrograms and administered directly to the lungs. The most dominant characteristics of MDI include their portability, convenience of use and quick effect. MDI comprises of drug formulation, propellant, metering valve, actuator, and container. This review contains overview of excipient selection, primary packaging material, propellant selection and formulation development of pMDI. Two of the most commonly used methods for the manufacturings of MDIs are cold filling method and pressure filling method.This review demonstrates different analytical techniques for characterization of pMDI’s like uniformity of delivered dose, water content, spray pattern and plume geometry were discussed. This review also presents in-vitro characterization, pharmacokinetic and pharamcodynamic study of MDI.


BIONANOPARTICLES: A GREEN NANOCHEMICAL APPROACH

{ DOWNLOAD AS PDF }

ABOUT AUTHORS:
Rahul Kumar*, Ved Prakash Singh, Damini Maurya, Anand Kumar Pandey
Department of Biotechnology, Institute of Engineering and Technology
Bundelkhand University, Jhansi, Uttar Pradesh, India
vnsanand_9@rediffmail.com

ABSTRACT
Nanoparticle, a core of bio-nanoparticle, which is used for polymers including natural and synthetic polymer and form different types of, liposomal and polymer nanoparticle. The designing, synthesis and manipulation of structures which is smaller than 100 nm, is termed as Nanotechnology. Nanoparticles are developed as a colloidal structure, synthesized by semi-synthetic and synthetic polymers. The emerging area of nanotechnology and Nano-sciencesare the application of nanoparticles, ranges in 1 to 100 nanometre (nm). The synthesis of silver nanoparticles for their potential application, it was originate to be eco-friendly and reliable, because of their exclusive properties. Mostly synthesis of AgNPs, by physical and chemical methods are too expensive, toxic, hazardous chemicals for various biological risks.The main objective of this study preferably lies thatgreen synthesis of AgNPs by several plants and its metabolites, extracts can be much safer to handle and easily available. The synthesis of AgNPs  are using several plants extract such as Oryza sativa, Zea mays, Basella alba, Helianthusannuls, Camellia sinensis ( green tea), Azadirachta indica (neem) ,Ssebania drummondii (leguminous shrub)sp. The AgNPs get attached in the cell wall of microorganism and can disturb the cellular respiration, permeability of the cell wall. Sometimes it can penetrate inside the cell wall which can interact protein, DNA, sulphur and phosphorus and causing cellular injury inside cell. It confers the antimicrobial activity. The AgNPs shows less antimicrobial activity against gram positive bacteria in comparison to gram negative bacteria because gram negative contain β-barrel proteins (i.e. Porins) and thinner peptidoglycan. The distinguishing property of silver nanoparticles it can be have higher surface area to volume ratio. When surface area increases the catalytic activity and surface energy of AgNPs corresponding to increase and biological effectiveness also increases. 

It identified that amalgamation of silver nanoparticle biochemical process is very fast process as compare to using microorganism (even several hours to few days). The NPs monodispersity, size are significant part in the valuation of NPs amalgamation. Therefore, operative regulator of monodispersity and NPs size are essentially examined. On numerous readings silver nanoparticle synthesis by microbes can be decompose later withassured dated of time. Thus the constancyof nanoparticle producebiological approachesmerits supplementary learning.


MEDICAL USES OF RADIOPHARMACEUTICALS

{ DOWNLOAD AS PDF }

ABOUT AUTHORS:
Mohammad Akbar Dar, Mubashir Hussain Masoodi*, Saeema Farooq
Dept. of Pharmaceutical Sciences,
Faculty of Applied Sciences, University of Kashmir, Srinagar, J&K, India
akbardr297@gmail.com

ABSTRACT
A radiopharmaceutical is a preparation intended for in-vivo use that contains a radionuclide in the form of a simple salt or a complex.  It may exist as a solid, liquid, gas or a pseudo gas. The chemical and physical identity and a form of a radiopharmaceutical are very important because in each case, once administered the radiopharmaceutical is intended to target certain tissues, binding sites, biochemical pathways. A radiopharmaceutical can be used for either diagnostic or therapeutic purposes depending on its specific physicochemical and radiation properties. The characteristic of radioactive decay is what makes radioisotopes useful in their medical applications; however, different applications will take advantage of radioactive emissions in different ways. Radioactive materials are regularly used to treat medical conditions, diagnosis pathology, visualize and measure physiological functions, and localize structures and pathways. This review describes both the therapeutic as well as diagnostic uses of radiopharmaceuticals.


Pages

 

FIND MORE ARTICLES