# overview
Over 17 years of research experience in the general areas of pharmaceutical sciences and drug delivery systems, with special expertise in the area of formulation design and process development. Research areas are: 1) formulation and process design of complex drug delivery systems (such as liposomes, nanoparticles, transdermal, implant, emulsions, microspheres, pediatric etc.); 2) improving drug product quality as well as process understanding through Quality by Design (QbD) approach and Process Analytical Technologies (PAT); 3) development of in vitro release performance tests for traditional (tablets, capsules, gels, emulsions) as well as complex drug delivery systems (microspheres, liposomes, nanoparticles, transdermal, implant, emulsions, ointments, creams, etc.); 4) evaluation of bio-equivalence of complex drug dosage forms; 5) design and evaluation of abuse deterrent formulations (ADF) for opioid analgesics, 6) 3-dimensional printing of various dosage forms for pharmaceutical application, 7) continuous manufacturing of pharmaceutical dosage forms and 8) univariate and multivariate models (chemometrics, mega-data analysis) development for various phases (polymorphs, amorphous, solvates, salt or base) quantification in the drug products. Other areas of intense research interest include protein and peptide delivery using polymeric materials in formulation design and risk analysis.

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United States Food And Drug Administration

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United States Food And Drug Administration

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Extended Release, In-use Stability, Dissolution

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United States Food And Drug Administration

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Critical Quality Attributes Droplet Size

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Chemometric Model Development and Comparison of Raman and (13)C Solid-State Nuclear Magnetic Resonance-Chemometric Methods for Quantification of Crystalline/Amorphous Warfarin Sodium Fraction in the Formulations.

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Cholorpheniramine tannate complexes: physicochemical, chemometric, and taste masking evaluation.

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Chemometric evaluation of near infrared, fourier transform infrared, and Raman spectroscopic models for the prediction of nimodipine polymorphs.

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Potential Application of USP Paddle and Basket Dissolution Methods in Discriminating for Portioned Moist Snuff and Snus Smokeless Tobacco Products.

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Design and evaluation of bilayer floating tablets of captopril.

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Quantitative estimation of phenytoin sodium disproportionation in the formulations using vibration spectroscopies and multivariate methodologies.

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Monitoring tablet surface roughness during the film coating process.

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Ion-pair chromatography for simultaneous analysis of ethionamide and pyrazinamide from their porous microparticles.

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Ocular pharmacoscintigraphic and aqueous humoral drug availability of ganciclovir-loaded mucoadhesive nanoparticles in rabbits

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Ultra-long acting prodrug of dolutegravir and delivery system - Physicochemical, pharmacokinetic and formulation characterizations.

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Leachable diphenylguanidine from rubber closures used in pre-filled syringes: A case study to understand solid and solution interactions with oxytocin.

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Opportunities and Challenges of Selective Laser Sintering 3D Printing in Personalized Pharmaceutical Manufacturing

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Therapeutic Application of Microsponges-based Drug Delivery Systems.

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Development of a Multivariate Predictive Dissolution Model for Tablets Coated with Cellulose Ester Blends.

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Understanding effect of formulation and manufacturing variables on the critical quality attributes of warfarin sodium product.

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Physicochemical and mechanical properties of carbamazepine cocrystals with saccharin.

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Nanometric gold in cancer nanotechnology: current status and future prospect.

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A headspace-gas chromatography method for isopropanol determination in warfarin sodium products as a measure of drug crystallinity.

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Electroporation: an avenue for transdermal drug delivery.

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Development of performance matrix for generic product equivalence of acyclovir topical creams.

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Preparation of carabeef and beef salamis by incorporating different levels of fat

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Lipid-Based Nanosystem As Intelligent Carriers for Versatile Drug Delivery Applications.

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Development and validation of X-ray diffraction method for quantitative determination of crystallinity in warfarin sodium products.

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Characterization of 5-fluorouracil microspheres for colonic delivery.

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Solid Matrix Based Lipidic Nanoparticles in Oral Cancer Chemotherapy: Applications and Pharmacokinetics.

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Simple and sensitive high-performance liquid chromatographic method for determination of transdermally applied flurbiprofen in rat plasma and excised skin samples

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Effect of drug-to-lipid ratio on nanodisc-based tenofovir drug delivery to the brain for HIV-1 infection.

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Evaluation of In-Use Stability of Anticoagulant Drug Products: Warfarin Sodium.

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Univariate and Multivariate Models for Determination of Prasugrel Base in the Formulation of Prasugrel Hydrochloride Using XRPD Method.

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Prospective Corollary of Ophthalmic Nanomedicine A Concept Shift toward Chitosan-Based Mucoadhesive Nanomedicine

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Non-destructive methods of characterization of risperidone solid lipid nanoparticles.

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Chemometric methods for the quantification of crystalline tacrolimus in solid dispersion by powder X-ray diffractrometry.

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Development and Validation Of A Discriminatory Dissolution Method for Portioned Moist Snuff and Snus.

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Characterization of a nonribosomal peptide antibiotic solid dispersion formulation by process analytical technologies sensors.

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Selective laser sintering 3D printing - an overview of the technology and pharmaceutical applications.

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Effect of Isopropyl Myristate on Transdermal Permeation of Testosterone From Carbopol Gel.

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Nanomedicines as cancer therapeutics: current status.

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Spectral and spatial characterization of protein loaded PLGA nanoparticles.

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Transdermal delivery of flurbiprofen: permeation enhancement, design, pharmacokinetic, and pharmacodynamic studies in albino rats.

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Comparison of X-ray powder diffraction and solid-state nuclear magnetic resonance in estimating crystalline fraction of tacrolimus in sustained-release amorphous solid dispersion and development of discriminating dissolution method.

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Application of NIR chemometric methods for quantification of the crystalline fraction of warfarin sodium in drug product.

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Development of meloxicam in situ implant formulation by quality by design principle.

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Development and evaluation of a pH-dependent sustained release tablet for irritable bowel syndrome.

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Tacrolimus properties and formulations: Potential impact of product quality on safety and efficacy

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3D-printing of lopinavir printlets by selective laser sintering and quantification of crystalline fraction by XRPD-chemometric models.

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In-Situ Implant Formulation of Laurate and Myristate Prodrugs of Dolutegravir for Ultra-Long Delivery.

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Evaluation of Abuse-Deterrent Characteristics of Tablets Prepared via Hot-Melt Extrusion.

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Preparation and characterization of dicarboxylic acids salt of aripiprazole with enhanced physicochemical properties.

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Quality by design approach for formulation development: a case study of dispersible tablets.

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3D printing for drug delivery and biomedical applications.

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Formulation and process factors influencing product quality and in vitro performance of ophthalmic ointments.

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Role of nanomedicines in delivery of anti-acetylcholinesterase compounds to the brain in Alzheimer's disease.

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Improvement in bioavailability of transdermally applied flurbiprofen using tulsi (Ocimum sanctum) and turpentine oil.

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Root cause evaluation of particulates in the lyophilized indomethacin sodium trihydrate plug for parenteral administration.

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Development and validation of an ultra-high-performance liquid chromatography-tandem mass spectrometry method to determine the bioavailability of warfarin and its major metabolite 7-hydroxy warfarin in rats dosed with oral formulations containing different polymorphic forms.

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Sample Size for Tablet Compression and Capsule Filling Events During Process Validation.

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Tulsi oil as a potential penetration enhancer for celecoxib transdermal gel formulations.

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Very-Rapidly Dissolving Printlets of Isoniazid Manufactured by SLS 3D Printing: In Vitro and In Vivo Characterization.

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An overview of Terminalia arjuna: Chemistry and pharmacological profile

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Assessing impact of formulation and process variables on in-vitro performance of directly compressed abuse deterrent formulations.

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Understanding the effects of formulation and process variables on the printlets quality manufactured by selective laser sintering 3D printing.

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Orally disintegrating tablet of novel salt of antiepileptic drug: formulation strategy and evaluation.

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THERMAL INFLUENCE ON PRINTLET QUALITY IN THE SELECTIVE LASER SINTERING OF PHARMACEUTICAL FORMULATIONS

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Salt Engineering of Aripiprazole with Polycarboxylic Acids to Improve Physicochemical Properties.

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Crystallinity evaluation of tacrolimus solid dispersions by chemometric analysis.

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Preparation and Characterization of Stable Amorphous Glassy Solution of BCS II and IV Drugs.

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Impact of formulation and process variables on solid-state stability of theophylline in controlled release formulations.

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Transdermal delivery of flurbiprofen: Permeation enhancement, design, pharmacokinetic, and pharmacodynamic studies in albino rats

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Application of chemometric methods to differential scanning calorimeter (DSC) to estimate nimodipine polymorphs from cosolvent system.

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Additive Manufacturing with 3D Printing: Progress from Bench to Bedside.

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Influence of drug loading and type of ointment base on the in vitro performance of acyclovir ophthalmic ointment.

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Near-infrared and fourier transform infrared chemometric methods for the quantification of crystalline tacrolimus from sustained-release amorphous solid dispersion.

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Regulatory Considerations in Development of Amorphous Solid Dispersions

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Formulation and evaluation of a protein-loaded solid dispersions by non-destructive methods.

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Assessing the impact of nimodipine devitrification in the ternary cosolvent system through quality by design approach.

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Chemometric Models for Quantification of Carbamazepine Anhydrous and Dihydrate Forms in the Formulation.

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Tannate complexes of antihistaminic drug: sustained release and taste masking approaches.

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Product and process understanding of a novel pediatric anti-HIV tenofovir niosomes with a high-pressure homogenizer.

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Integrating QbD Tools for Flexible Scale-Up Batch Size Selection for Solid Dosage Forms.

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Effects of Diluents on Physical and Chemical Stability of Phenytoin and Phenytoin Sodium.

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Blend of cellulose ester and enteric polymers for delayed and enteric coating of core tablets of hydrophilic and hydrophobic drugs.

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Development and Validation of a Discriminatory Dissolution Method for Rifaximin Products.

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Effect of processing parameters and controlled environment storage on the disproportionation and dissolution of extended-release capsule of phenytoin sodium.

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In-use stability assessment of FDA approved metformin immediate release and extended release products for N-Nitrosodimethylamine and dissolution quality attributes.

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Physico-mechanical and stability evaluation of carbamazepine cocrystal with nicotinamide.

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Effect of incorporation of fermented bamboo shoot on physicochemical and microbial quality of pork pickle.

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Lesson Learnt from Recall of Valsartan and Other Angiotensin II Receptor Blocker Drugs Containing NDMA and NDEA Impurities.

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Nitroso Impurities in Drug Products: An Overview of Risk Assessment, Regulatory Milieu, and Control Strategy.

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Online monitoring of PLGA microparticles formation using Lasentec focused beam reflectance (FBRM) and particle video microscope (PVM).

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In-vivo evaluation in rats of colon-specific microspheres containing 5-fluorouracil.

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Spectroscopic-Based Chemometric Models for Quantifying Low Levels of Solid-State Transitions in Extended Release Theophylline Formulations.

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Quality by design approach for understanding the critical quality attributes of cyclosporine ophthalmic emulsion.

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Development of Abuse-Deterrent Formulations Using Sucrose Acetate Isobutyrate.

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Development of Methamphetamine Abuse-Deterrent Formulations Using Sucrose Acetate Isobutyrate.

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Risperidone solid dispersion for orally disintegrating tablet: its formulation design and non-destructive methods of evaluation.

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Coating characterization by hyperspectroscopy and predictive dissolution models of tablets coated with blends of cellulose acetate and cellulose acetate phthalate.

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Development of stable amorphous solid dispersion and quantification of crystalline fraction of lopinavir by spectroscopic-chemometric methods.

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Studying effect of glyceryl palmitostearate amount, manufacturing method and stability on polymorphic transformation and dissolution of rifaximin tablets.

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Kinetics of drug release from ointments: Role of transient-boundary layer.

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Chemometric Assisted X-Ray Powder Diffractometry Method for Crystalline Lopinavir Quantification in 3D Printlets Manufactured by Selective Laser Sintering

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Understanding the quality of protein loaded PLGA nanoparticles variability by Plackett-Burman design.

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Determination of tacrolimus crystalline fraction in the commercial immediate release amorphous solid dispersion products by a standardized X-ray powder diffraction method with chemometrics.

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Omega-3 fatty acids as pharmacotherapeutics in psoriasis: current status and scope of nanomedicine in its effective delivery.

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Using Metabolite Data to Develop Patient Centric Specification for Amide Impurity in Vildagliptin Tablets

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Application of salt engineering to reduce/mask bitter taste of clindamycin.

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Hunter screening design to understand the product variability of solid dispersion formulation of a peptide antibiotic.

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Improvement of physicochemical properties of an antiepileptic drug by salt engineering.

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Quality and In-Use Stability Comparison of Brand and Generics of Extended-Release Phenytoin Sodium Capsules.

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Nanomedicine Based Drug Targeting in Alzheimer's Disease: High Impact of Small Carter

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Formulation Optimization of Selective Laser Sintering 3D-Printed Tablets of Clindamycin Palmitate Hydrochloride by Response Surface Methodology.

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Is the demonstration of bioequivalence for clavulanic acid required in amoxicillin-clavulanic acid orally administered immediate-release products?

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Effects of excipients and curing process on the abuse deterrent properties of directly compressed tablets.

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Comparison of Univariate and Multivariate Models of C SSNMR and XRPD Techniques for Quantification of Nimodipine Polymorphs.

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Evaluation of Potential Application of Sucrose Acetate Isobutyrate (SAIB) in Combination with Following Polymers in the Development of Abuse Deterrent Formulations of Opiod Drugs

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Eastman Chemical Company - (Kingsport, Tennessee, United States)

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Dissolution of smokeless tobacco products

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Food and Drug Administration - (Nonthaburi, Thailand)

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Performance evaluation of polymers blend as an enteric coating material for pharmaceutical use

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Eastman Chemical Company - (Kingsport, Tennessee, United States)