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Sam T Mathew 

Asst: Manager
Medical Writing,
Accenture Pharmaceutical Services,
Bangalore,
India
samtmat@yahoo.com
A highly motivated pharmaceutical professional with a proven academic and industrial performance, excellent organizational and leadership qualities, analytical and problem solving skills, innovative and critical thinking, attention to detail, good listening skills, and a good team player with strong commitment to continuous learning.

A doctorate in pharmacy (Pharmaceutics), with >10 years of pharmaceutical research experience (6 years academic research and >4 years pharmaceutical industry), of which 7 years in medical/publication/scientific writing domain. Worked in different capacities in medical/publication/scientific writing domain such as writer, reviewer, author, project lead, project manager, team lead, mentor, trainer, publication planning team member etc.

Currently working with Accenture Pharmaceutical services, Bangalore, India as Asst. Manager in Medical writing. Prior to this worked with Novartis Pharmaceuticals, Hyderabad, India as Senior Publication Writer/Senior Scientific Writer. Previously, worked as Scientist-Formulation development in managerial grade at Viziphar biosciences, Bangalore, India.

Served/serving as visiting teaching faculty in pharmacy colleges under Jawaharlal Nehru Technological University, Hyderabad, India and guided/guiding postgraduate and doctoral students for their Pharm. D, M Pharm. and Ph.D. courses. Acted as invited speaker for few national/international conferences conducted by recognized organizations/institutions.

To the credit of the academic research >21 scientific research articles are published in peer reviewed international journals. Presented papers at 3 international and 9 national conferences. Serving as Editor-in-chief of ‘The Internet Journal of Pharmacology’ and Editor of ‘Pharma Scientist’. Also serving as scientific peer reviewer for Springer, Science direct, Elsevier, Bentham and AAPS scientific journals. Selected as Marques World ‘WHO IS WHO’ for the year 2010.

PROFESSIONAL ACHIEVEMENTS AND AWARDS:

Developed a process map for a leading pharmaceutical company in consultation with an international
outsourcing agency
Instrumental in setting up a publication writing group for a leading pharmaceutical company
Had been responsible for bringing several key medical writing projects to fruition
Selected as Marques World ‘WHO IS WHO’ for the year 2010
Scientific peer reviewer for journal of ophthalmology, AAPS Pharm Scitech, International journal
of pharmaceutics, Journal of controlled release, Journal of molecular pharmaceutics, AAPS Pharm Scitec, Journal of controlled release, etc
Editor-in-chief of ‘The Internet Journal of Pharmacology’ a peer reviewed online scientific journal published by Internet Scientific Publications, LLC, USA
Editor of ‘Pharma Scientist’ a peer reviewed online scientific journal published by Pharma IT solutions.
Received Senior research fellowship (ICMR, New Delhi) for the doctoral project
Honorary visiting faculty in pharmacy colleges under JNTU, Hyderabad, India
Guiding Ph.D. and M Pharm. students under JNTU, Hyderabad, India

RESEARCH EXPERIENCE

Extensively worked on formulation and evaluation of Novel Drug Delivery Systems such as microspheres/microparticles, nanoparticles, liposomes, buccal/transdermal patches and their in vivo bioavailability studies on laboratory animals
Developed bucco-adhesive patches of selected proton pump inhibitors
Developed new oral gel formulations for veterinary use
Developed oral liquid formulation for joint care of dogs
Developed 3 parenteral dosage forms (IV) for preclinical evaluation in animals
Worked on the topic “Formulation and evaluation of microspheres of ketoprofen and ketorolactromethamine for controlled release”
Worked on a project entitled “The fffect of meloxicam on the bioavailability and in vitro protein binding of rifampicin”
Worked on buccal patches of selected statin derivatives, and nanoparticles of BCS class 2 drugs
Have undergone a practical training in the Manufacturing and Quality Control of Tablets & Capsules at CARYL PHARMA, Bangalore, India
Actively involved in doctoral and postgraduate projects carried out at Al Amen College of pharmacy, Bangalore, India and Sri Ramakrishna institute of Pharmaceutical sciences, Coimbatore, India

PROFESSIONAL INTERESTS

Competitive intelligence and strategic planning
Scientific writing/critical evaluation of scientific and regulatory documents
Pharmacokinetic and bioavailability/bioequivalence studies
Development of Novel Drug Delivery Systems
Intellectual property rights and regulatory affairs
Development of cosmetic formulations
Development of conventional dosage forms
Pre-formulation Studies
Academic research and teaching

PROFESSIONAL COMPETENCY

Clinical domain knowledge
Writing/ editing and reviewing scientific/regulatory documents
ICH-GCP guidelines
Bioavailability and bioequivalence study
Formulation and evaluation (in vitro and in vivo) of Novel Drug Delivery Systems such as microspheres/microparticles, nanoparticles, liposomes, buccal/transdermal patches, etc
Development of suitable dosage forms of new molecules to be subjected for pre-clinical studies
Formulation of solid, liquid and semisolid conventional dosage forms
Stability studies for dosage forms as per ICH guidelines
Development of OTC cosmetic formulations such as gels, creams, pastes, and patches
Design of experiments using statistical software
IPR related work
Hands on experience in newer analytical techniques such as: HPLC, Gas Chromatography, Texture analyzer, DSC, SEM, UV-Spectrophotometer, FTIR-Spectrophotometer, ELISA, Malvern Mastersizer 2000, etc


Journal articles

2012
2011
 
PMID 
Ayarivan Puratchikody, V V Prasanth, Sam T Mathew, B Ashok Kumar (2011)  Mucoadhesive patches of Salbutamol sulphate for unidirectional buccal drug delivery: development and evaluation.   Curr Drug Deliv 8: 4. 416-425 Jul  
Abstract: Mucoadhesive buccal patches of Salbutamol Sulphate were prepared using five different polymers (polyvinylpyrrolidone [PVP]), polyvinyl alcohol [PVA], water soluble chitosan [CH(WS)], acid soluble chitosan [CH(AS)], hydroxypropyl methyl cellulose [HPMC])in various proportions and combinations (CH(WS)/PVP/HPMC, CH(WS)/PVA/HPMC, CH(AS)/PVP/HPMC, and CH(AS)/PVA/HPMC). A 3(2) full factorial design was used to design the experiments. A total of 72 patches were prepared. Thickness of the patches ranged between 0.3±0.003 and 0.6±0.009 mm. Mass of the patches were in the range of 68.12±4.6 to 95.02±7.2 mg. Patches showed increased mass whenever PEG -400 was used as plasticizer. The surface pH of patches were acidic to neutral (pH 4-pH 7). Patches showed satisfactory drug loading efficiency (85%to 97%). Eight formulations(C9, C18, C27, C36, D9, D18, D27, and D36)-which showed high folding endurance- were selected for further characterization. Patches with PEG -400 showed higher swelling index when compared to PG. The residence time of the patches ranged between 115 min and 120 min. Formulation C18 showed the maximum in vitro drug release of 101.4 % over a period of 120 min. Formulations D36 and C36 were best fitted to Higuchi model. The remaining formulations were best fitted to the Korsmeyer-Peppas model. Drug permeation was fast and showed the similar profile as that of the in vitro drug release. Patches were stable, during and at the end of the accelerated stability study.
Notes:
 
DOI 
Sam T Mathew, S Gayathri Devi, Prasanth V Viswandan, Vinod Balan (2011)  Efficacy and Safety of COX-2 Inhibitors in the Clinical Management of Arthritis: Mini Review   ISRN Pharmacology 2011: 2011. Article ID 480291  
Abstract: In the clinical management of arthritis, the choice of nonsteroidal anti inflammatory drug (NSAID) remains confusing and controversial. A common practice on the choice of NSAID in clinical management of arthritis is the risk benefit ratio. The main objective of this review is to addresses the main arguments for the pharmacological and clinical use of COX-2 inhibitors in relation to nonselective NSAIDs for the clinical management of arthritis. This review concluded that, both NSAIDs and COX-2 inhibitors are equally effective and are associated with increased risk of GI, renal, and CV, adverse effects. Complete understanding of the patientâs comorbid conditions and concomitant medications, coupled with precise monitoring during the treatment, may help to decrease the threat of adverse effects induced by nonselective NSAIDs and selective COX-2 inhibitors.
Notes:
 
DOI 
A Puratchikody, V V Prasanth, Sam T Mathew, B Ashok Kumar (2011)  Buccal Drug Delivery: Past, Present and Future – A Review   International Journal of Drug Delivery 3: 2. 171-184  
Abstract: The major hindrance for the absorption of a drug taken orally is extensive first pass metabolism or stability problems within the GI environment like instability in gastric pH and complexation with mucosal membrane. These obstacles can be overcome by altering the route of administration as parenteral, transdermal or trasmucosal. Among these trasmucosal has the advantage of ease of administration, patient compliance and are economic too. The mucosa of the buccal cavity is the most easily accessible transmuocosal site. Buccal transmucosal delivery helps to bypass first- pass metabolism by allowing direct access to the systemic circulation through the internal jugular vein. The buccal transmucosal route has been researched for a wide variety of drugs. Several methodologies have been considered so far, to design and manipulate the release properties towards the invention of buccal mucosal delivery systems. This article aims at reviewing the numerous techniques that has been designed till date for optimizing buccal transmucosal drug delivery.
Notes:
V V Prasanth, Akash Chakraborthy Moy, Sam T Mathew, Rinku Mathappan (2011)  Microspheres- An overview   International Journal of Research in Pharmaceutical and Biomedical Sciences 2: 2. 332-338  
Abstract: There are various departments of medicine like cancer, pulmonary, cardiology, radiology, gynaecology, and oncology etc, numerous drugs are used and they are delivered by various types of drug delivery system. Among them microspheric drug delivery system has gained enormous attention due to its wide range of application as it covers targeting the drug to particular site to imaging and helping the diagnostic features. It also has advantage over various other dosage forms like we know for lungs disease now a days aerolised drugs are used for local delivery of drugs but it has disadvantage of shorter duration of action so for sustained release and reducing side effects and hence to achieve better patient compliance microspheres can be used. It also has advantage over liposomes as it is physicochemically more stable. Moreover the microspheres are of micron size so they can easily fit into various capillary beds which are also having micron size. The purpose of the review is to compile various types of microspheres, different methods to preparation, its applications and also various parameters to evaluate their efficiency.
Notes:
 
PMID 
A Puratchikody, V V Prasanth, S T Mathew, B A Kumar (2011)  Mucoadhesive Patches of Salbutamol Sulphate for Unidirectional Buccal Drug Delivery: Development and Evaluation   Current Drug Delivery (Accepted for publication) April  
Abstract: Mucoadhesive buccal patches of Salbutamol Sulphate were prepared using five different polymers (polyvinylpyrrolidone [PVP]), polyvinyl alcohol [PVA], water soluble chitosan [C(WS)], acid soluble chitosan [C(AS)], hydroxypropyl methyl cellulose [HPMC])in various proportions and combinations (C(WS)/PVP/HPMC, C(WS)/PVA/HPMC, C(AS)/PVP/HPMC, and C(AS)/PVA/HPMC). A3(2) full factorial design was used to design the experiments. A total of 72 patches were prepared. Thickness of the patches ranged between 0.3±0.003 and 0.6±0.009 mm. Mass of the patches were in the range of 68.12±4.6 to95.02±7.2mg. Patches showed increased mass whenever PEG -400 was used as plasticizer. The surface pH of patches were acidic to neutral (pH 4-pH 7). Patches showed satisfactory drug loading efficiency (85%to 97%). Eight formulations(C9, C18, C27, C36, D9, D18, D27, and D36)-which showed high folding endurance- were selected for further characterization.Patches with PEG -400 showedhigher swelling index when compared to PG. The residence time of the patches ranged between 115 min and 120 min.Formulation C18 showed the maximum in vitro drugrelease of 101.4 % over a period of 120 min. Formulations D36 and C36 were best fitted to Higuchi model. The remaining formulations were best fitted to the Korsmeyer-Peppas model. Drug permeation was fast and showed the similar profile as that of the in vitro drug release. Patches were stable, during and at the end of the accelerated stability study.
Notes:
V V Prasanth, Sirisha Mudiyala, Sam T Mathew, Rinku Mathappan (2011)  Buccal tablets as mucoadhesive drug delivery- An overview   Journal of Pharmacy Research 4: 3. 706-709  
Abstract: Per-oral drug administration is the traditional and most common method of drug administration but the drugs bioavailability is reduced as it is subjected to extensive pre-systemic degradation in the gut wall (or) liver. Parenteral route of drug administration achieves 100% bio-availability but due to poor patient acceptability and the risk of maintaining drug levels in the blood in cases of chronic medication makes it undesirable. The buccal mucosa is more robust and less prone to irreversible irritation or damage and this route of administration is one of the trans-mucosal deliveries of drugs. Hence it shows high patient acceptance and compliance. This review on buccal tablets gives the information about buccal mucosa structure, its permeability, theories of muco-adhesion, formulation and method of manufacture of buccal tablets and various evaluation methods for buccal tablets.
Notes:
V Felix Joe, V V Prasanth, B A Viswanath, Rinku Mathappan, Kamalakkannan Vairappan, Sam T Mathew (2011)  Formulation and evaluation of Pseudoephedrine hydrochloride and Loratadine extended release tablet   Journal of Pharmacy Research 4: 2. 507-508 February  
Abstract: The present study was aimed to develop extended release tablets of pseudophedrine hydrochloride and loratadine using hydroxy propyl methyl cellulose and sodium carboxymethylcellulose in different proportions a matrix material in core tablet and loratadine is used as immediate release for this a film coating formula was developed, so as to provide immediate release from the zone of coating. The results of the dissolution study indicated the formulations FC â VI and FC â VII showed maximum drug release up to 12 hr, the release of the drug was found to be dependent on the relative proportions of hydroxypropylmethylcellulose and sodiumcarboxymethylcellulose used in core tablet. Mathematical treatment of the in vitro drug release data suggests that, all the formulations best fitted into first order release kinetics. Drug release from the matrix occurred by combination of two mechanisms, diffusion of drug from tablet matrix and erosion of tablet surface.
Notes:
2010
Sam T Mathew, S Gayathri Devi, V V Prasanth, B Vinod (2010)  Suitability of Factorial Design in Determining the Processing Factors Affecting Entrapment Efficiency of Albumin Microspheres   Journal of Pharmacy Research 3: 5. 1172-1177 May  
Abstract: Introduction: A trend in NSAID development has been to formulate them into sustained release microspheres to improve therapeutic efficacy and to reduce the severity of upper gastro intestinal side effects. Many processing variables can influence the characteristics of the resultant albumin microspheres. Objective: The objective of the present study was to study the effect of some selected process variables (drug/albumin ratio, amount of glutaraldehyde, and duration of cross-linking time) on the encapsulation efficiency, by applying 3-level full factorial design analysis, accounting for percent drug entrapment as dependant variable. Methods: Sustained-release formulations of ketorolac tromethamine loaded albumin microspheres were prepared by chemical crosslinking method. F-statistic was applied to reduce polynomial equation by neglecting non-significant (P>0.05) terms.The coefficient value for independent variable, drug/albumin ratio, was found to be maximum (19.33) and hence this variable was considered to be a major contributing variable for percent drug entrapment. Response surface plots clearly showed optimal drug/albumin ratio, amount of glutaraldehyde and duration of cross-linking. The conformity of the established equation was checked by preparing three batches of microspheres thrice, taking values of the independent variables from the contour plots for prefixed value of percent drug entrapment. Conclusion: Findings established the role of the statistical design in predicting the values of independent variables for preparation of microspheres having predetermined percent drug entrapment.
Notes:
2009
2009
 
DOI   
PMID 
Sam T Mathew, S Gayathri Devi, V V Prasanth, B Vinod (2009)  Formulation and in vitro-in vivo evaluation of ketoprofen-loaded albumin microspheres for intramuscular administration.   J Microencapsul 26: 5. 456-469 Aug  
Abstract: The objective of this work was to prepare and evaluate ketoprofen-loaded albumin microspheres for intramuscular administration. Microspheres were prepared by emulsion cross-linking method using a 2(3) factorial design and the effect of different factors on entrapment efficiency was determined. Microspheres were evaluated for entrapment efficiency, percentage yield, particle size and release behaviour. Selected formulations were then tested by differential scanning calorimetry, X-ray diffraction and scanning electron microscopy. Further they were analysed for residual solvents, syringeability and stability. Microspheres were then sterilized and bioavailability studies were carried out in New Zealand white rabbits. The physical characteristics of microspheres showed that they were suitable for IM administration. The sterilization technique adopted was adequate to maintain sterility. In vivo studies showed increase in C(max), AUC, t(1/2) and MRT (p < 0.05) administered in the form of microspheres. MRT of ketoprofen was almost 3.2-times in the form of microspheres. From these results it was concluded that the developed albumin microspheres of ketoprofen is a potential delivery system for once-a-day intramuscular administration.
Notes:
2008
 
DOI   
PMID 
K V Sandhya, Gayathri S Devi, Sam T Mathew (2008)  Liposomal formulations of serratiopeptidase: in vitro studies using PAMPA and Caco-2 models.   Mol Pharm 5: 1. 92-97 Jan/Feb  
Abstract: The feasibility of using liposomes as a potential oral delivery system for the systemic delivery of other peptides and protein-based pharmaceuticals has been studied. Serratiopeptidase, a proteolytic enzyme, was used as a model drug. Liposomes were prepared by a thin film hydration method using various lipids, namely, soya lecithin, DMPC and DMPE. It was further investigated whether the liposomal formulations of serratiopeptidase altered the permeability/absorption of the drug using PAMPA, a non-cell-based assay, and Caco-2 assay, a cell monolayer system, mimicking in vivo GI epithelium cells. The entrapment efficiency of the formulations was found to be 62%, 84% and 86% for the liposomes of soya lecithin, DMPC and DMPE respectively. The effectiveness of the liposomal formulations against the pure drug in terms of permeability/absorption was compared. The effective permeability (log Pe) values from PAMPA study varied from -7.47 to -6.5 cm/s whereas for the serratiopeptidase it was -7.72 cm/s. The apparent permeability values calculated from Caco-2 assay varied from 1.25 x 10(-6) to 1.61 x 10(-6) cm/s whereas for the serratiopeptidase it was 1.25 x 10(-6) cm/s. The flux was found to be 3.88-4.96 microg/cm (2)/h for the formulations when compared to 3.208 microg/cm(2)/h for serratiopeptidase. The results obtained indicated that in comparison with the pure drug, incorporation of drug into liposomes improved the permeability. Thus it could be concluded that the liposomal formulations would improve the oral absorption of serratiopeptidase.
Notes:
 
PMID 
K V Sandhya, S Gayathri Devi, Sam T Mathew (2008)  Quantitation of serrapeptase in formulations by UV method in the microplate format.   Curr Drug Deliv 5: 4. 303-305 Oct  
Abstract: Serrapeptase is an anti-inflammatory, proteolytic enzyme isolated from the microorganism, Serratia sp. HY-6. Very few methods are available for the quantification of serrapeptase. The activity of the enzyme is determined by an ELISA assay, colorimetric method using casein as substrate or by HPLC method. These methods are lengthy, time consuming and require a number of reagents and solvents. Therefore an attempt was made to develop a simple alternative method for regular estimation of drug in formulations. Serrapeptase enzyme was estimated in formulations by using microplate readers which uses the principle of vertical photometry. Further this method was validated and the robustness of this method was checked by estimating the drug in various formulations including liposomes and marketed tablet formulations. A linear relationship between drug concentration and absorbance was observed between 1-4 microg/ml at 230 nm (R(2)=0.9911). The percentage recovery values of the drug in serrapeptase liposomes were found to lie within the standard limit (97-98%) which confirms the method is accurate and free from any positive or negative interference of the excipient. The low value of standard deviation obtained confirms the precision of the method. (+/-0.020 - +/-0.044). The drug content values in marketed tablets values obtained matched the label claim. The proposed microplate UV-method for determination of serrapeptase in formulations is novel, simple, inexpensive, fast, specific and robust. Thus this method could be a better alternative for regular estimation of drug in the various marketed formulations of serrapeptase.
Notes:
2007
 
DOI   
PMID 
Sam T Mathew, S Gayathri Devi, K V Sandhya (2007)  Formulation and evaluation of ketorolac tromethamine-loaded albumin microspheres for potential intramuscular administration.   AAPS PharmSciTech 8: 1. 02  
Abstract: The objective of this work was to prepare and evaluate ketorolac tromethamine-loaded albumin microspheres using a factorial design. Albumin microspheres were prepared by emulsion cross-linking method. Selected formulations were characterized for their entrapment efficiency, particle size, surface morphology, and release behavior. Analysis of variance (ANOVA) for entrapment efficiency indicated that entrapment efficiency is best fitted to a response surface linear model. From the statistical analysis it was observed that as the drug:polymer (D:P) ratio and volume of glutaraldehyde increased, there was a significant increase in the encapsulation efficiency. Scanning electron microscopy of the microspheres revealed a spherical, nonporous and uniform appearance, with a smooth surface. Based on the entrapment efficiency and physical appearance, 9 formulations were selected for release study. The maximum particle size observed was below 40 microm. The release pattern was biphasic, characterized by an initial burst effect followed by a slow release. All selected microspheres, except those having less polymer proportion (D:P ratio is 1:1), exhibited a prolonged release for almost 24 hours. On comparing r (2) values for Higuchi and Peppas kinetic models, different batches of microspheres showed Fickian, non-Fickian, and diffusion kinetics. The release mechanism was regulated by D:P ratio and amount of cross-linking agent. From the experimental data obtained with respect to particle size and extent of drug release, it could be concluded that the prepared microspheres are useful for once-a-day intramuscular administration of ketorolac tromethamine.
Notes:

Conference papers

2006
2005
2004
2002
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