Expert Details

Expert in Formulation, Development and Manufacturing of Pharmaceutical Dosage Forms

Expert ID: 726302 Australia

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Expert has extensive product development experience in solid dosage forms (TABLETS {IR & ER} HARD & SOFT GELATIN CAPSULES AND POWDERS); Liquid dosage forms ( SOLUTIONS, SUSPENSIONS & EMULSIONS) from conception through to stability trail, clinical studies, validation; final manufacture, registration and release with many years in humans and veterinary pharmaceuticals. He had good experience in troubleshooting and process improvement.

Expert has extensive knowledge on developed and manufacturing of controlled release sold dosage forms including hydrophyllic and hydrophobic matrix systems and multiparticulate dosage forms. He has very good experience in development of softgel or soft gelatin capsules & hard gelatin capsules and experienced in solving all kinds of ongoing production problems. He has extensive knowledge on development and manufacture of all kinds of softgel gels like enteric coated, controlled relaese and concentional neutraceutical softgel products.

He is experienced in the development of Immediate release and Exended release solid dosage forms and he has very good experience in technology transfer and technical support to solve ongoing production problems. In addition to developing several prescription drug products, he has extensive experience in the development of OTC products. He has produced both controlled release as well as immediate release hormone, anti cancer, antibiotic, steroid, cough and cold, oral care, systemic and topical products for both OTC and professional marketing.

He has vast knowlege on development of all kinds of controlled release like matrix type, microencapsulation; osmotic, flotable; microballone systems and make it commercilase. Expert has very good experience in development and manufacturing of all knds of liquid dosage forms like solutions, suspensions and emulsions. He has good knowledge on development of all kinds of sustanined release forms. He has vast knowledge on improvement the bioavailability of poorly soluble drugs at the commercial level.

He has good knowledge in hard gelatin cpsules development, technology transfer and trouble shooting. He has good knowledge on development of solid, liquid and semisolid dosage forms, from development, technology transfer and trouble shooting. He has good knowledge on all kinds of OTC products development. He worked on number of molecules to develop parenteral products. He has very good experience on all kinds of oral drug delivery systems. Expert's experienced in development and manufactur of all kinds of softgel capsules.

Education

Year Degree Subject Institution
Year: 2002 Degree: Ph.D Subject: Pharmaceutical technology Institution: Andhra University, India
Year: 1995 Degree: M.Pharm Subject: Pharmaceutical Technology Institution: Andhra University, India
Year: 1993 Degree: B. Pharm Subject: Pharmaceutical Sicences Institution: Andhra University, India

Work History

Years Employer Title Department Responsibilities
Years: 2010 to Present Employer: Undisclosed Title: Head - Research and Development Department: Responsibilities: 1. Leading highly motivated and target oriented team of scientists for product development and coordinates with Regulatory, Quality Assurance, Marketing and Manufacturing departments.
2. Responsible for develop various kinds of dosage forms like TABLETS (IR & ER), capsule (HARD & SOFTGEL), LIQUIDS; CREAMS/OINTMENTS from conception through stability trial, clinical studies, validation, final manufacture, registration and release for non-regulated and regulated markets like TGA, MEDSAFE & US-FDA etc
3. Technical Support to production
Years: 2005 to 2010 Employer: Title: Snr. Principal R&D Scientist Department: Responsibilities: 1. Development of generic products for US companies like ENDO Pharmaceuticals; IMPAX ect.
2. Responsible for develop various kinds of dosage forms like TABLETS (IR & ER), capsule (HARD & SOFTGEL), LIQUIDS; CREAMS/OINTMENTS from conception through stability trial, clinical studies, validation, final manufacture, registration and release for non-regulated and regulated markets like TGA, MEDSAFE & US-FDA etc
3. Technical Support to production
4. Lead the R&D group and coordinates with Regulatory, Clinical, Marketing and Manufacturing teams.
Years: 2002 to 2005 Employer: Title: R&D Scientist Department: Responsibilities: Developed Veternary products for USA, Australia and New Zealand Markets
2. Project planning, development and management disciplines and reporting
3. Developed new technologies for kept incompatible drugs in single unit dosage forms and patent.
5. Development of bioequivalent generic products to seek USFDA approval.
6. Involved in many cost reduction projects, which are on going production batches.
7. Solved some of the problems, which occurred in on going production batches in injectables, liquids and semi solid dosage forms.
Years: 2002 to 2003 Employer: University of Auckland, Auckland, NEW ZEALAND Title: Department: School of Pharmacy Responsibilities: 1. Given the support to establish the newly established School of Pharmacy Deportment.
Developed lipid based drug deliver systems for poorly soluble systems.
2. Evaluated the new excipient for controlled release dosage form and applied for the patent.
3. Performing research and development, which is aimed at presenting solutions to NZ companies incorporating recent advances in science and technology.
Years: 2001 to 2002 Employer: Title: Research & Development Executive Department: Responsibilities: 1. Development of bioequivalent ANDA products to seek USFDA approval under Para 1, 2, 3 & 4 filing.
2. Developed delayed release formulation for rifampicin.
3. Prepared oral dosage forms like tablets, liquids, injectables and ointments.
4. Involved in many cost reduction projects, which are on going in production.
5. Solved some of the problems, which occurred in ongoing production batches.
Years: 2001 to 2001 Employer: Title: Research & Development Executive Department: Responsibilities: 1. Developed floatable drug delivery systems for ciprofloxacin, amoxycillin.
2. Handled various granulation techniques (Aqueous, Nonaqueous and melt) for oral controlled and immediate release products. Prepared oral dosage forms like, tablets, capsules, liquids, and ointments.
3. Involved in many cost reduction projects, which are ongoing in production.
4. Solved some of the problems, which occurred in ongoing production batches.
Years: 1996 to 1998 Employer: NET Pharmacy College, Raichur, INDIA Title: Department: Responsibilities: 1. Taught a group of Pharmaceutics subjects to undergraduate students.
2. Consultation to the pharmaceutical companies.

International Experience

Years Country / Region Summary
Years: 2005 to Present Country / Region: AUSTRALIA Summary: Development of various types of dosage forms from conception through to stability trail, clinical studies, validation; final manufacture, registration and release with many years in humans and veterinary pharmaceuticals for non-regulated and regulated markets like TGA, MEDSAFE and US-FDA etc. His expertises include supervision of R&D team and coordination with Marketing, regulatory affairs, clinical, Quality assurance and production departments and he has very good knowledge in formulation improvement and process quality improvement. He has much knowledge on different kinds of dosage forms like SOLID DOSAGE FORMS (TABLETS, HARD & SOFT GELATIN CAPSULES), INJECTABLES, OINTMENTS/ CREAMS, TRANS DERMAL DRUG DELIVER SYSTEMS AND LIQUID DOSAGE FORMS. Expertise on development of NDDS products and many years of experience in PATENT writing and analysis.
Years: 2002 to 2005 Country / Region: NEW ZEALAND Summary: Development of Various kinds of dosage forms in veternary pharmaceuticals.

Additional Experience

Training / Seminars
Provide training /seminars on cGMP; product development and regulatory requirements for USFDA; UK-MHRA and TGA.
Marketing Experience
In-depth knowledge on manufacturing facility setup / R&D facility setup & product development and technical support on softgel capsules; solid dosage forms, liquid dosage forms and semisolid dosage forms.

Language Skills

Language Proficiency
English He has high level of proficiency in writting and spoken technical english

Fields of Expertise

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