# 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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Extended Release, In-use Stability, Dissolution

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Critical Quality Attributes Droplet Size

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United States Food And Drug Administration

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United States Food And Drug Administration

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United States Food And Drug Administration

# publications[].label
Evaluation of In-Use Stability of Anticoagulant Drug Products: Warfarin Sodium.

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

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

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

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

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Oral Bioavailability Enhancement of Poorly Soluble Drug by Amorphous Solid Dispersion Using Sucrose Acetate Isobutyrate.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Crystallinity evaluation of tacrolimus solid dispersions by chemometric analysis.

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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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Physicochemical and mechanical properties of carbamazepine cocrystals with saccharin.

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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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Monitoring tablet surface roughness during the film coating process.

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

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Regulatory Considerations in Development of Amorphous Solid Dispersions

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

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

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Chapter 11 Nanoparticles for improvement in oral bioavailability

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

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

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

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

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

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

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Electroporation: an avenue for transdermal drug delivery.

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

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

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A Comparative Study in Metformin Tablet Quality Assessment: LC-MS and LC-MS/MS Method Quantification of N-Nitroso-Dimethylamine in the Presence of Dimethyl Formamide

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

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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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Chapter 46 Printing of personalized medication using binder jetting 3D printer

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

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

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

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

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Characterization of 5-fluorouracil microspheres for colonic delivery.

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

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Therapeutic Application of Microsponges-based Drug Delivery Systems.

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

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

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

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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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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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Development and Characterization of Printlets of Lamivudine for Pediatric Patients Using Selective Laser Sintering.

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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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Appropriateness of Dissolution Methods on Evaluation of Digoxin Product Quality.

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

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

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Risk-Based Approach for Defining Retest Dates for Active Pharmaceutical Ingredients and Excipients.

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

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

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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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Design and evaluation of bilayer floating tablets of captopril.

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

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

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

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Nanomedicines as cancer therapeutics: current status.

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Development of Abuse-Deterrent Formulations Using Sucrose Acetate Isobutyrate.

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An overview of Terminalia arjuna: Chemistry and pharmacological profile

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3D printing for drug delivery and biomedical applications.

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

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

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

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

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

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

# publications[].label
Transdermal delivery of flurbiprofen: permeation enhancement, design, pharmacokinetic, and pharmacodynamic studies in albino rats.

# publications[].label
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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Spectral and spatial characterization of protein loaded PLGA nanoparticles.

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

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

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Scientific and Regulatory Considerations in Product Development

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

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

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

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

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Development, Pharmacokinetics and Antimalarial Evaluation of Dose Flexible 3D Printlets of Dapsone for Pediatric Patients.

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

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

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

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

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

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

# researcherOn[].label
Performance evaluation of polymers blend as an enteric coating material for pharmaceutical use

# researcherOn[].awardedBy.label
Eastman Chemical Company - (Kingsport, Tennessee, United States)

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Dissolution of smokeless tobacco products

# researcherOn[].awardedBy.label
Food and Drug Administration - (Nonthaburi, Thailand)

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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

# researcherOn[].awardedBy.label
Eastman Chemical Company - (Kingsport, Tennessee, United States)