1. | METHOD DEVELOPMENT, VALIDATION AND FORCED
DEGRADATION STUDY OF VOCLOSPORIN BY UV
SPECTROMETRIC METHOD |
| Yasotha Selvan*, Kamalakannan Dhanabalan, R.Manivannan, Kowshik Srinivasan,
Maneesh P Shaji Shaji Joseph, Mohanraj Selvam, Muthuraman Muthusamy,
Sumithraj Ravichandran |
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The assay of an absorbing substance may be quickly carried out by preparing a solution in a transparent solvent and
measuring its absorbance at a suitable wavelength. The wavelength normally selected is a wavelength of maximum absorption
(? max), where small errors in setting the wavelength scale have little effects on the measured absorbance. Aim of the present
study is to develop an accurate, precise, sensitive, reproducible, analytical technique and forced degradation study to determine
the Voclosporin in pharmaceutical dosage forms. Voclosporin is a calcineurin inhibitor for the treatment of lupus nephritis
(LN). Lupus nephritis (LN) is a type ofglomerulonephritis occurring in patients with systemic lupus erythematosus (SLE). The
linearity data for Voclosporin is given in capsule; the linearity plots of Voclosporin at 222 nm. The regression equation and
correlation coefficient forthe calibration cure of Voclosporin at 222 nm were found linear in the concentration range of 1.9 -
11.8 µg/mL at wavelength. Simple, precise and accurate UV spectrophotometric method were developed and validated as per
ICH guidelines for the estimation of Voclosporin in capsule dosage form.
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2. | FORMULATION AND IN-VITRO EVALUATION OF NYSTATIN
MICROSPHERES LOADED TRANSDERMAL GEL |
| Ballanki Tharun Teja, Swathi A |
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Nystatin is an antifungal medication. It is used to treat Candida infections of the skin including diaper rash, thrush,
esophageal candidiasis, and vaginal yeast infections. It may also be used to prevent candidiasis in those who are at high risk.
Nystatin may be used by mouth, in the vagina, or applied to the skin. The aim of the present study is to formulate and
evaluate microspheres loaded transdermal gel containing Nystatin as a model drug microsphere were prepared by using
aqueous ionotropic gelation method. Different polymers, different drug to polymer(s) ratio(s) and other parameters were
screened to study their effects on properties of microspheres and to optimize each parameter. The microspheres obtained
were subjected to preformulation studies like bulk density, tapped density, angle of repose, carr’s index, hausner’s ratio the
results obtained were within the limit. The microspheres were characterized by Percentage yield, Drug entrapment efficiency,
Particle size analysis, then the optimized microspheres formulation F3 were incorporated into the gel prepared with various
grades of carbopol polymer(s) ratio(s) and was evaluated by parameters like Visual inspection , pH measurement ,
Spreadability studies , Viscosity and invitro drug release by using franz diffusion cell for results from the diffusion results F5
showed maximum percentage drug release of 96.72 hence it was considered as the optimized formulation
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3. | RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR
SIMULTANEOUS ESTIMATION OF BEMPEDOIC ACID AND
EZETIMIBE IN BULK AND PHARMACEUTICAL DOSAGE FORM |
| Swetha K, Rajitha S |
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New method was established for simultaneous estimation of Bempedoic acid and Ezetimibe by RP-HPLC method. The
chromatographic conditions were successfully developed for the separation of Bempedoic acid and Ezetimibe by using ACE
C18 column (4.6×150mm) 5µ, flow rate was 1.2 ml/min, mobile phase ratio was (70:30 v/v) methanol:Phosphate buffer pH 3
(pH was adjusted with orthophosphoricacid), detection wavelength was 240nm. The instrument used was Shimadzu, model
No. SPD-20MA LC+20AD, Software- LC-20 Solution. The retention times were found to be 2.733 mins and 3.415 mins. The
% purity of Bempedoic acid and Ezetimibe was found to be 101.27% and 99.97% respectively. The precision study was
precise, robust, and repeatable. LOD value was 3.17 and 5.68, and LOQ value was 0.0172 and 0.2125 respectively. Hence the
suggested RP-HPLC method can be used for routine analysis of Bempedoic acid and Ezetimibe in API and Pharmaceutical
dosage form
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4. | DEVELOPMENT AND EVALUATION OF MODIFIED RELEASE
DOSAGE FORMS BASED ON GASTRO RETENTIVE AND
OSMOTIC TECHNOLOGY PRINCIPLES |
| Bhanu Pratap Yadav*, Surendra Pratap Singh, Jitendra Kumar Malik, Sonam Baghel |
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The present study involves the design and characterization of floating microspheres with Dilteazem Hydrochloride as model
drug for prolongation of tonic clonic jerk time, microsphere of Dilteazem Hydrochloride, was developed to reduce the
frequency of drug administration, ease of dose adjustment and improve patient compliance. In this study, the shape and
surface morphology of microspheres were characterized by scanning electron microscopy. In vitro drug release studies were
performed and drug release kinetics was evaluated using the linear regression method. Effects of polymer concentration,
solvent composition, particle size, drug entrapment efficiency and drug release were also studied. The synthesized
microspheres exhibited prolonged drug release (> 10 h) and remained buoyant for > 24 h. The drug entrapment efficiency
was in the range 50-70 %. At higher polymer concentration, the average particle size was increased and the drug release rate
decreased. In vitro studies revealed diffusion-controlled drug release from the microspheres. Among all the formulations (F1-
F6), F3 is the optimized formulation of Dilteazem Hydrochloride was prepared by solvent evaporation techniques using Ethyl
cellulose as polymer and particle size, microsphere efficiencies and in vitro release of the fabricated microsphere were
evaluated. Particle sizes of the microspheres were influenced by the concentration of Ethyl cellulose and stirring speed. From
the results of the in vitro study shows that the desired release rate is achieved by ethyl cellulose. The object of this study was
to develop and evaluate stable microspheres of Dilteazem Hydrochloride drug an antiepileptic drug using combination of
Eudragit and ethyl cellulose as polymer which delivers the drug at a controlled rate for a prolonged period of time. Ethyl
cellulose used in this study and it is showing hard binding of microspheres.
Keywords: Dilteazem Hydrochloride, Sustained release, Ethyl Cellulose
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5. | DEVELOPMENT AND VALIDATION OF UV
SPECTROPHOTOMETRIC METHODS FOR THE SIMULTANEOUS
ESTIMATION OF NAPROXEN SODIUM AND CODEINE
PHOSPHATE IN BULK AND PHARMACEUTICAL
FORMULATIONS |
| Anil Kumar S. Manchi, Naren Yadav R C*, Lavanya Patil M P, Shwetha M |
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Two UV Spectrophotometric methods were developed and validated for the simultaneous estimation of Naproxen Sodium
(NAP) and Codeine Phosphate (COD) in bulk and in its tablet dosage forms as per ICH guidelines. Sodium hydroxide is
used as a solvent. The stock solutions were prepared by using 0.1 N sodium hydroxide as a solvent. In the Zero order
derivative method, NAP showed maximum absorbance at 262 nm and COD showed maximum absorbance at 284 nm. In the
Third order derivative method, NAP showed maximum absorbance at 264 nm and COD at 281 nm. Calibration graph was
obtained in the concentration range of 50-250 ?g/ ml for NAP and 5-25 ?g/ ml for COD in both methods. The LOD and
LOQ value of the drugs in zero order derivative method was found to be 3.59 ?g/ ml and 10.89 ?g/ ml for NAP and 0.29
?g/ ml and 0.90 ?g/ ml for COD. In third order derivative method LOD and LOQ value of NAP is 5.21 ?g/ ml and 15.81 ?g/
ml and for COD is 0.41 ?g/ ml and 1.25 ?g/ ml. The developed methods were validated according to ICH guidelines. The
developed methods were found to be simple, accurate and precise for the routine analysis of the NAP and COD in bulk and
tablet dosage forms
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6. | FORMULATION AND EVALUATION OF INNOVATIVE
METFORMIN NANOEMULSION FOR IMPROVED THERAPEUTIC
OUTCOMES IN TYPE 2 DIABETES MELLITUS |
| Purushothaman M, Yashwanth P, Pavan S, Bhavani V, Rajya Lakshmi B, Ashwini H |
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This study aims to formulate and evaluate an innovative nanoemulsion of Metformin for enhanced therapeutic outcomes in
the treatment of Type 2 Diabetes Mellitus. Metformin, a first-line antidiabetic drug, often exhibits suboptimal bioavailability
due to its poor solubility and limited gastrointestinal absorption. The primary objective was to develop a nanoemulsion-based
drug delivery system to overcome these limitations and improve the drug's pharmacokinetic profile. The formulation process
involved screening various oils, surfactants, and co-surfactants to identify the most effective combination for Metformin
solubilization. Oleic acid, Tween 80, and Transcutol P were selected as the oil phase, surfactant, and co-surfactant,
respectively, based on their high emulsification efficiency and compatibility with Metformin. Pseudo-ternary phase diagrams
were constructed to determine the optimal ratios of these components, ensuring the formation of a stable nanoemulsion. The
optimized nanoemulsion was characterized for droplet size, polydispersity index (PDI), zeta potential, and stability. The
stability studies confirmed no significant changes in these parameters over three months. In vitro release studies showed a
significantly higher dissolution rate of Metformin from the nanoemulsion compared to the conventional tablet form. The
cumulative drug release from the nanoemulsion reached 94.5% within 60 minutes, whereas the conventional formulation
released in the same period. The study concluded that the Metformin nanoemulsion formulation significantly enhances
solubility and dissolution rate, suggesting its potential to improve therapeutic outcomes in Type 2 Diabetes Mellitus. Further
in vivo studies are warranted to evaluate the pharmacokinetic parameters and clinical efficacy of the developed
nanoemulsion
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