Pharmaceutical Dosage Form Consultant: Oral Solid Dosage Forms, Excipients, Formulation and Water Soluble Cellulose Ethers

Expertise

• Formulation and process development, scale-up, technology transfer and production troubleshooting of pharmaceutical oral solid dosage forms.
• Extensive experience as a supplier of water soluble polymers to the pharmaceutical industry.
• Excipient business development and technical service.
• Expert on water soluble cellulose ethers, wet granulation for sustained release and related drug formulations.
• Use of water soluble polymers in granulation, film coating and sustained release matrix formulation.
• Regulatory compliance work on pharmaceutical companies operating under a consent decree.
• Founded the Hercules "Aqualon" Pharmaceutical Lab as premier facility for excipient research production and testing of the drug product.

Experience

Formulation and Process Development

• Production troubleshooting and process optimization of a two drug combination sugar coated tablet in late stage development.
• Utilizing mathematical tools to evaluate equipment process data and working with statisticians in process, finished product analysis data resulting in enhancement of product performance and process robustness.
• Statistical analysis techniques to set manufacturing specifications; exploratory work on multivariate process control.
• Performed a technical transfer from an existing generic abbreviated new drug application (ANDA) product that entailed: Complete assessment of all ANDA and regulatory documentation noting strengths and weaknesses; tech transfer between two plants with different types and sizes of process equipment; revamped to modern practice standard and obtained FDA approval.
• Performed technical transfer on an ANDA product to identify multiple deficiencies by applying analytical methods for API and DP that resulted in developing a new formula and manufacturing process and successful scale up.
• Developed a high dose tablet formulation with a greatly improved the product formulation and process that was successfully scaled up to full production batch scale.
• Identified and resolved production complications of a family of marketed tablet products with minor formulation and process changes with dramatic improvements in performance.
• Performed API scale up with associated tech transfers from US to offshore manufacturer.
• Developed a lower dose formulation of an existing drug product for use in preparing clinical supplies for a federally sponsored study.
• Conducted basic research on a marketed drug to reduce the dose of the drug, thereby improving bioavailability.
• Conducted extensive research on hydroxypropyl and hydroxyethyl cellulose excipients and their use in the formulation and processing of oral solid dosage forms.
• Conducted research on the thermoplastic and micromeritic properties of cellulosic polymers, leading into the development of new grades and custom designed for use in immediate and sustained release formulations.
• Conducted research on the use of hydroxypropyl cellulose In tablet binding resulting in manufacturing cost reduction without sacrificing binder performance. "Klucel" EXF is now one of the leading tablet binders used in pharmaceutical formulation.
• Conducted research on the use of both hydroxypropyl and hydroxyethyl cellulose in sustained release matrix tablet formulation. The factors investigated were: degree of polymerization of the polymer, particle size of the polymer, effect of drug solubility on dissolution rates, effect of wet granulation vs. direct compression on dissolution, effect of tablet hardness and stability effects.

Regulatory Compliance

• Reviewed IQ/OQ protocols and summary reports on the following packaging equipment: Fillers, cottoners, cappers, labelers, cartoners, shrink wrappers, case packers, and palletizers for bottle and blister pack lines.
• Reviewed packaging line PQ protocols and summary reports. In addition, reviewed IQ/OQ protocols and summary reports on supporting utilities such as nitrogen distribution systems, compressed air systems and HVAC systems.
• Reviewed process equipment protocols for granulation, compression and tablet coating equipment.
• Conducted a gap analysis of a four department vaccine development group.
• Prepared a protocol for conducting the gap analysis and performed training on the protocol to meet compliance updates for the FDA.
• Led teams in preparing corrective action plans and timetables in response to gap analysis findings.
• Developed responses to compliance observations made by a 3rd party auditor for a major pharmaceutical company's API manufacturing plant which was under a consent decree. All commitments were successfully verified for 5 different time periods preventing a $15,000 a day penalty per commitment.
• Organized the staff and directed activities of a team of experts in preparation for a pre-approval inspection at three separate sites, resulting in FDA approval for commercial production and testing of the drug product.

Employment History

• Pharmaceutical Consulting Services, Inc, Technical Services and Formulation Consultant
• Cell Pathways, Inc., Director, Pharmaceutical Development
• IBAH Pharmaceutics Services, Inc., Director Pharmaceutical Development
• Hercules Inc., Manager, "Aqualon" Pharmaceutical Laboratory
• Stuart Pharmaceutical Division of ICI (AstraZeneca), Senior Formulation Pharmacist
• William H. Rorer, Inc. (Adventis), Pharmaceutical Chemist

Honors & Publications

Academic and Professional Affiliations

• American Assoc. Pharm. Sciences: PT Section Program Planning Committee
• Philadelphia Pharmaceutical Forum: Chairman
• Eastern Pharmaceutical Technology Meeting: General Chairman
• International Pharmaceutical Excipients Council: Founding Board Member

Publications

• Published 23 technical bulletins on the use of water soluble polymers in granulation, film coating and sustained release matrix formulation.
• Presented more than 15 technical papers and posters at national and international pharmaceutical scientific meetings.

Education

• M.S. University of Maryland, School of Pharmacy
• B.S. University of Maryland, School of Pharmacy