American Journal Of Pharmacy And Health Research

ISSN NO.: 2321-3647
August 2013 Issue 5

Advance approach on the Impurity Profile of Pharmaceutical Dosage forms: A Review

Jitendra S Patel1*, Chirantan N Patoliya1, Punit M Patel1, Sandip Dholakia1Madhabhai M. Patel1

1.Shankersinh Vaghela Bapu Institute of Pharmacy, Vasan, Gandhinagar


As per ICH guideline impurity may be defined as any component of drug product that is not the drug substance or an excipient. Now a day apart from purity profile there are an increasing essentiality of impurity profile by regulatory agency. Different regulatory agencies like ICH,USFDA, TGA, etc. work on control and identification of impurities in pharmaceutical dosage forms. To identify and characterize impurities are essential for establishing the biological safety of an pharmaceutical dosage forms. The various pharmacopoeias like IP, BP, USP, etc. were allowed certain limits of impurities in pharmaceutical dosage forms. This review article mainly focuses on various methods available to identify and characterize impurities in pharmaceutical dosage forms. Among all, the most specific techniques are NMR, MASS, GC-MS, LC-MS, HPLC-DAD-MS, LC-MS-MS, HPLC-DAD-NMR-MASS, Capillary electrophoresis, Mass and Flash chromatography.

Key words: Impurities, identification, HPLC-DAD-MS.


Advances in Diabetes Mellitus: A Contemporary Review

Santosh S. Chhajed*1, Arvind B. Naik2, Angel P. Godad2, Jineetkumar B. Gawad2

1. SSDJ College of Pharmacy Chandwad, Dist: Nasik (M.S) India.

2. St. John Institute of Pharmacy & Research Palghar (E), Dist: Thane (M.S) India.


Diabetes mellitus is a group of metabolic disorder in which a person has high blood sugar either because the body does not produce enough insulin or because cells do not respond to the insulin. There are three main types of diabetes, Type I, Type II and Gestational, insulin therapy is used for the treatment of diabetes by administration of exogenous insulin.  Several classes of oral hypoglycemic agents like sulfonylureas, biguanides and alpha-glucosidase inhibitors are available for the treatment of type II diabetes.  Tremendous advances have occurred in past few decades. New technologies include a variety of alternatives to needle injection for insulin delivery, advances in blood glucose (BG) monitoring devices and novel treatment technologies. The overall goal of DM technology to improve BG control, avoid long term complications and improve patient quality of life. Although these new technologies interesting to use, they must improve outcomes such as BG control and prevent long term complications to be effective and receive widespread acceptance. 

Keywords: Diabetes Mellitus, Insulin, Oral Hypoglycemic Agents, Advance Therapies.


Penetration and Identification of Drug Use and Abuse in Hair by Various Advanced Analytical Techniques

Jitendra S Patel1*, Toral V Patel1, Shreena N Khant1, Sandip Dholakia1, Madhabhai M Patel1

1.Shankersinh Vaghela Bapu Institute of Pharmacy, Vasan, Gandhinagar, 382650


Now a days, besides blood, urine, saliva & hair is being recognized as an alternative & fundamental biological specimen for drug testing in the field of forensic analysis & clinical chemistry. Hair testing was used in legal cases, historical researches. This review on methodologically & practically used to the application of hair as a biological indication of drug use & abuse. The mechanism of drug incorporation into the hair were commented. This article include sample (hair) collection, preparation & extraction methods as well as the advanced analytical techniques such as immunoassay, HPLC-CE, GC-LC & GC-MS/MS. The outcome of hair analysis had been review for this categories: drugs of abuse(Opiates, Cocaines. Amphetamine, Cannabinoids) & Benzodizapines, prescribed drugs etc. finally the specific purpose of hair testing was discussed along with their interpretation.

Keywords: hair, drugs of abuse, prescribed drugs, advanced analytical techniques. 


Design and Evaluation of Mucoadhesive Gel of Glimepiride for Nasal Delivery

Aakash B. Patel 1*, S B.Gondkar1, R B. Saudagar1

1.Department of Quality Assurance Techniques, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, India.


Nasal Mucoadhesive gel of Glimepiride was prepared  for  Controlled release.  Carbopol 934p was used as a key ingredient which gives mucoadhesion property to the gel formulations. Different formulations were prepared by varying the concentrations of Carbopol 934p and Hydroxyl Propyl Methyl Cellulose K4M (HPMC K4M). These formulations were evaluated for parameters like pH, Drug content, Viscosity, Mucoadhesive strength, Gel strength, In-vitro drug release, In-vitro permeation and Drug excipient compatibility. In this formulation the release profile depend on the concentration of Carbopol 934p and HPMC K4M. A 32 factorial design was applied to see the effect of  variables Carbopol 934p (X1) and HPMC K4M (X2) on the response percentage drug release  as a dependent variable. In vitro release data were fitted to various models to ascertain kinetic of drug release. Regression analysis and analysis of variance were performed for dependent variables. The results of the F-statistics were used to select the most appropriate model.  Formulation containing Carbopol 934p(1.0%) and HPMC K4M(1.0%) was found to be  optimum. The studies indicate that the formulation was effective in providing In-vitro release of drug and the mucoadhesive formulation

Keywords: Nasal Mucoadhesive gel, Gel strength, In-vitro drug release, In-vitro permeation


Evaluation of Protective Potential of Green Tea on Experimentally Induced Cardiotoxicity and Nephrotoxicity In Rats

Ayaz Ahmad1,*, Gyas Khan2, Sonu Sherma3

1.School of Pharmacy and Medical Sciences, Singhania University, Pacheri Bari, Jhunjhunu, Rajasthan, 333515. India

2.Jazan University, kingdom of Saudi Arabia.

3.Nims Institute of pharmacy, Nims University Shobha nagar, Jaipur.


Green tea extract (GTE) having so many flavonoid that protect doxorubicin induced cardiotoxicity and nephrotoxity in rats. A single dose of Doxorubicin (20 mg/kg i.p) on 29th day of treatment produced cardiotoxicity. A single dose of cisplatin (6 mg kg−1) was used to induce nephrotoxicity. Wistar Albino rats weighing between 150-200 g were distributed into eight groups comprising of eight animals in each group. Thiobarbituric acid reactive substances (TBARS), GSH, Superoxide dismutase (SOD), and Catalase (CAT) were estimated in heart tissue Reduced glutathione (GSH), Lactate dehydrogenase (LDH), Serum glutamate oxaloacetate (SGOT) and Creatinine phosphokinase (CPK) were estimated in blood. Histopathological studies were performed for the heart tissue of all the groups. DOX induced high serum levels of LDH, CPK and SGOT were reduced while GSH was increased significantly by GTE administration as compared to DOX receiving rats. Pretreatment with GTE ameliorated the cardiac content of GSH, SOD and CAT activities where as MDA level decreased significantly. Scr (serum creatinine) and BUN (blood urea nitrogen) were also estimated. The results support the antioxidant properties of GTE, which indicate cardioprotective role against Doxorubicin (DOX) induced cardiotoxity and nephroprotective role against cisplatin induced nephrotoxicity and its importance as adjuvant therapy in cancer management.

Keywords: Green tea extract, Doxorubicin, cisplatin, Antioxidants, Lipid peroxidation.


Formulation and In Vitro Evaluation of Fexofenadine HCl Fast Dissolving Tablets

Hussain Raviteja. K1*, Amarnath. S2, Venkatesh. P3, Naresh Kumar. SR4.

1. Department of Pharmaceutical Analysis & Quality Assurance, School of Pharmacy,

Anurag Group of Institutions, Venkatapur, R.R Dist, Andhra Pradesh, India.

2. Department of Pharmaceutics, Rao’s college of Pharmacy, Nellore, Andhra Pradesh, India.

3. Department of Medicinal Chemistry, NIPER, Balanagar, Hyderabad, Andhra Pradesh, India.

4. Department of Pharmacoinformatics, NIPER, Kolkata, Andhra Pradesh, India.


A fast-dissolving drug delivery system is a tablet that dissolves or disintegrates in the oral cavity without the need of water or chewing. These are novel types of tablets that disintegrate/dissolve/ disperse in saliva within few seconds. According to European Pharmacopoeia, the Oral Dissolving Tablet should disperse/disintegrate in less than three minutes. The basic approach used in development of Fast Dissolving Table is the use of super disintegrant  like Crospovidone, which provide instantaneous disintegration of tablet after putting on tongue, thereby releasing the drug in saliva.  Crospovidone is a disintegrating agent at the 4-8% level and is an effective binder–disintegrant in tablets prepared using wet granulation. Furthermore, swelling properties paired with particle size distribution make the finer grades of Crospovidone work efficiently in fast-disintegrating formulation. Powders are evaluated for flow properties like Angle of Repose, Carr’s consolidation index and Hausner ratio were found to be within acceptance criteria to indicate good flow properties. Five tablets of each formulation with varying concentration of Crospovidone were evaluated for different parameters like Hardness, Thickness, Friability, Weight variation and Disintegration time were found to be within acceptance criteria. The F3 containing 7.2% w/w of Crospovidone was found to be promising and has shown an in vitro disintegration time of 20 sec when compared to control which shows 300 sec. By increasing super-disintegrant concentration for different formulations, our results reveal that the F3 has shown better release compared to control in 20 mins.

Keywords: Fast Dissolving Tablet, Fexofenadine HCl, Crospovidone, Direct Compression method.


Development and in-vitro Characterization of Mucoadhesive in situ Nasal Gel of Ondansetron

Anjan De1*, Subrata Chakraborty1 , Souvik Ghatak1  & Biswarup Das2

1Dr.B.C.Roy College of Pharmacy and AHS, Durgapur-713206,W.B

2Simanta Institute of Pharmaceutical Sciences, Orissa-757086


The nasal route has gained importance in recent decades as a non-invasive drug application route that offers many advantages for the introduction of drugs into systemic circulation. Its major advantage is the rapid absorption of drugs and therefore quick onset of their effect. In addition, it has the advantage of avoiding the hepatic first-pass effect. Thus, nasal drug delivery may be used for either local or systemic effects. Cancer induced nausea and vomiting is one of the major side effects of the cancer chemotherapy. For the treatment of the CINV the use 5HT3 recepter antagonist is the most effective. Ondansetron has a oral bioavailability of 60% due to the first pass metabolism. So our objective was to prepare an in situ nasal gel of the Ondansetron using PF-127 as the thermo reversible polymer. There are many approaches for increasing the residence time of drug formulations in the nasal cavity resulting in enhanced drug absorption. We used HPMC E15 and Chitosan as the mucoadhesive polymer to increase the nasal residence time of the formulation. To increase the permeation we used Polyethylene Glycol 400 and Propylene glycol as the permeation enhancer. Further,  a 3-factor, 2-level full factorial design (23) study was carried out to optimize the Ondansetron gel with PF 127 amount (%, X1), permeation enhancers (PEG 400 1%/PPG 1%, X2) and polymers (HPMC E15 1 %/Chitosan 0.5 %, X3) as the prime selected independent variables, which were varied at 2 different levels (low and high). The effect of formulation variables on the response variables were statistically evaluated by using a commercially available software package Design-Expert® version 8.0 (Stat-Ease, Inc.).The formulation Om2 was found to be the best composition formula based on statistical finding, while conformation experiment also proves this result.

Keywords: Mucoadhesive, non-invasive, first-pass, CINV, in situ, factorial design  etc.