Nilesh Saindane

Meticulous and well-trained formulation development scientist bringing top-notch expertise in formulation development and contributing to successful product development.

Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

• Presented poster entitled "Counterfeit pharmaceuticals: Current status and prevention strategies" at 58th IPC, Mumbai, December, 2006
• Presented poster entitled "Evaluation of effect of molecular weight an degree of deacetylation of chitosan on its mucoadhesive property" at The Second Indo-Canadian Satellite Symposium, Ooty, February 2007
• Presented poster entitled "Rational use of anti-obesity drugs" at Bharati Vidyapeeths College of Pharmacy, Belapur, November 2006
• Presented poster entitled "Synthesis of water soluble β-cyclodextrin polymers and to explore their application in enhancing solubility of water insoluble drug" at 60th IPC, New Delhi, December 2008
• Presented poster entitled "Synthesis and characterization of amphiphilic star copolymer of betacyclodextrin and polypropylene oxide and their application as nanocarriers" at First European Cyclodextrin Conference at Aalborg, Denmark, October 2009
• Presented poster entitled "Controlled release formulation of Glipizide based on Interpolymer complexation of Carbopol-Hydroxypropyl methyl Cellulose" at 62th IPC, Manipal, December 2010

Leadership in Formulation Development

• Spearheaded the development of diverse pharmaceutical formulations, including immediate release (IR), extended release (ER), orally disintegrating tablets (ODT), sublingual products, and novel drug delivery systems (NDDS).
• Pioneered advanced drug delivery technologies such as osmotic drug delivery systems (push-pull and elementary systems), gastroretentive drug delivery systems (GRDDS), and melt granulation formulations.
• Led the development of solid oral products (IR, ER, ODT), suspensions, liquids, gels, eye drops, eye gels, and injection formulations, ensuring alignment with global regulatory standards.
• Directed the preparation of development proposals, technical reports, and protocols, ensuring clarity and compliance with project objectives.
• Conducted comprehensive literature and patent surveys to define innovative product development strategies and maintain competitive advantage.

Strategic and Technical Leadership

• Oversaw preformulation studies, including reference product evaluation and compatibility studies, to establish a strong foundation for formulation development.
• Championed formulation development, technology transfer, and scale-up activities, ensuring seamless transition from lab to commercial production.
• Evaluated and interpreted bioequivalence (BE) data and analytical data to guide formulation optimization and decision-making.
• Compiled and analyzed stability data to ensure product quality and compliance with ICH guidelines.
• Developed and reviewed scientific protocols, PDRs, BMRs, MFRs, product specifications, validation protocols, reports, and departmental SOPs to maintain operational excellence.
• Resolved technical challenges during product development, demonstrating strong problem-solving skills and ensuring project timelines were met.

Cross-Functional Collaboration and Innovation

• Collaborated with cross-functional teams, including R&D, quality assurance, regulatory affairs, and manufacturing, to drive successful product development and commercialization.
• Fostered a culture of continuous improvement by implementing best practices and innovative approaches in formulation development.
• Mentored and guided team members, enhancing their technical expertise and ensuring high-performance outcomes.

• Secured All India Rank 63 and 99.44 percentile in Graduate Aptitude Test in Engineering (GATE-2005), conducted by Indian Institute of Technology Bombay, Mumbai (IIT).
• Secured Rank 7 in Ph.D. Entrance examination conducted by ICT, Mumbai
• Awarded Junior Research Fellowship by All India Council for Technical Education for the period of two years during Master's degree (2005-2007)
• Awarded Senior Research Fellowship by University Grants Commission (UGC) for the period of four years during Ph.D. (Tech) degree (2008-2011).
• Awarded International Travel Grant by Department of Science and Technology (DST) for presentation entitled "Synthesis and Characterization of Amphiphilic Star Copolymer of Betacyclodextrin and Polypropylene Oxide and Their Application as Nanocarriers at European Cyclodextrin Conference 2009, Aalborg, Denmark

• Accepted Paper (Feb 2012), Osmotic pellet system comprising of osmotic core and in-process amorphized drug in polymer-surfactant layer for controlled delivery of poorly water-soluble drug, Journal of Pharmaceutical Sciences (Impact Factor 3.2).
• Accepted Paper, Mucoadhesive bilayered buccal patches for administration of sumatriptan succinate, AAPS PharmSciTech, Vol. 9, No. 3, September 2008. (Impact Factor 1.4, Citations 31).
• Accepted Paper, Nasal permeation enhancement of Sumatriptan through nasal mucosa, Indian Journal Pharmaceutical Sci., 2007, 69(5) 729-731 (Impact Factor 0.455, Citation 2).
• Accepted Paper, Synthesis and Characterization of Amphiphilic Star Copolymer of Betacyclodextrin and Polypropylene Oxide and Their Application as Nanocarriers, Journal of Inclusion Phenomena and Macrocyclic Chemistry, Vol 69, Number 3-4, 383-392. (Impact Factor 1.2, Citation 1).
• Accepted Paper, Inclusion complexation of weakly acidic NSAID with Beta-Cyclodextrin: selection of arginine, an amino acid, as a novel ternary component, Journal of Inclusion Phenomena and Macrocyclic Chemistry, Vol 69, Number 3-4, 453-460. (Impact Factor 1.2 Citations 4).
• Accepted Paper, Nanosuspension Based In-Situ Gelling Nasal Spray of Carvedilol: Development, in-vitro and in-vivo characterization December 2012, AAPS PharmSciTech(Impact Factor 1.4)
• Communicated Paper, Characterization of interpolymer complex of hydroxypropyl methyl cellulose and Carbopol for controlled drug release application, Journal of biomedical materials research part A (Impact Factor 3.1)

• Gender: Male
• Marital Status: Married
• Date of Birth: 04/09/82
• Nationality: Indian

• Indian Patent Approved on "Multiparticulate controlled porosity osmotic system", complete specification, Application no. 2677/MUM/2011
• Indian Patent Filed, "Pharmaceutical nasal spray composition for delivery of drugs", provisional application, Application no.2676/MUM/2011, Under Evaluation

• Jasco High performance liquid chromatography (HPLC)
• Waters High performance liquid chromatography (HPLC)
• Differential Scanning Calorimety (Perkin Elmer, Pyris 6)
• Particle Size Analyzer: Beckman Coulter and Malvern.
• High speed Centrifuges and Rota-evaporator
• 10 and 16 station rotary tablet press, Rimek Minipress-I and Cadmach, India.
• Dissolution tester and Disintegration, Electrolab
• Fluidized Bed Coater
• Rapid Mixer Granulator
• Convention Pan Coating and Autocoater

Passionate about reading scientific non-fiction books.