Expert Details

Expert in Formulation Liquids, Soft Gelatin, Two-piece Hard Capsules, and Process Development in Pharma

Expert ID: 733689 North Carolina, USA

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Expert has developed Soft Gelatin Capsules containing non-aqueous solution, suspension and self-emulsifying formulations for a variety of new chemical entities (NCE), prescription, highly insoluble compounds and OTC drugs.

This experience included conducting solubility studies with hydrophilic/lipophilic excipients, as well as the addition of surfactants, anti-oxidants, suspending agents. She has also performed drug chemical stability studies to identify optimal fill formulations for solutions/suspensions. For suspensions, Expert has performed sedimentation studies. She has also performed compatibility studies with different gelatin formulations used in soft gelatin capsules.

Expert has developed two-piece hard capsules containing solution and suspension fills. This experience included conducting pre-formulation and stability studies to identify optimal two-piece hard capsules.

Expert has also performed compatibility studies with HPMC and Gelatin hard capsules.

She has prepared small lab bench fills using bench mixers with propeller or saw tooth blades, homogenizer and handheld homogenizer.

She has performed dissolution and disintegration testing for soft gelatin capsules, as well as for two-piece hard capsules. She has also authored batch records, development reports, protocols, SOP's and working instructions. She has developed colors for Soft Gelatin Capsules as well.

Expert has developed and manufactured clinical, scale-up, registration and validation batches for two-piece hard capsules and soft gelatin capsules in PDS and Commercial Operations in a cGMP environment.

Her experience includes technology transfer from Pilot Plant to Commercial manufacture. This experience has included developing and optimizing manufacturing procedures, preparing batch records, and training Pilot Plant and Production personnel to manufacture under cGMP's.

Expert is quite familiar with liquid fill mixing processes using Lightnin, Cowels mixers with propeller or saw tooth blades, Fryma/Koruma, and Olsa Macef homogenizer (external anchor, internal blades and bottom homogenizer).

Her experience includes Shionogi Qualicaps Filling machines and Capsule Band sealing machines for two-piece hard capsules. Her experience also includes Shionogi Qualicaps Inpsection Machine (Capsule weight inspection) as well as rotary die encapsulation machines to manufacture soft gelatin capsules.

Expert has prepared and executed documentation for Installation Qualification (IQ) / Operational Qualification (OQ) of a variety of equipment.

Expert may consult nationally and internationally, and is also local to the following cities: Charlotte, North Carolina - Raleigh, North Carolina - Greensboro, North Carolina - Durham, North Carolina - Winston Salem, North Carolina - Fayetteville, North Carolina - Cary, North Carolina - High Point, North Carolina - Gastonia, North Carolina - Roanoke, Virginia

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Education

Year Degree Subject Institution
Year: 1982 Degree: Master in Science Subject: Chemistry Institution: University of North Carolina

Work History

Years Employer Title Department Responsibilities
Years: 2015 to 2016 Employer: Patheon Pharmaceutical (High Point, NC) Title: Sr. Scientist Department: Product Developement Responsibilities: Expert worked on projects involving the development and manufacture of soft gelatin capsules. She authored batch records, development reports, protocols, SOPs and Working instructions.
She collaborated and interfaced with external Clients.
She also worked collaboratively with Project Managers, the Engineering Department, Operations and QA.
Years: 2008 to 2015 Employer: Patheon Pharmaceutical (Cincinnati, OH) Title: Sr Scientist/Specialist Department: Product Development Responsibilities: Expert worked on projects involving development and manufacture of two-piece hard capsules and liquid oral products. She authored batch records, development reports, protocols, SOPs and Working instructions.
During this time, Expert collaborated and interfaced with external clients.
She also worked collaboratively with Project Managers, the Engineering Department, Operations and QA.
Years: 1995 to 2007 Employer: Banner Pharmacaps Title: Scientist Department: R&D Responsibilities: Expert worked on projects involving development and manufacture of two-piece hard capsules and liquid oral products. She authored batch records, development reports, protocols, SOPs and Working instructions.
During this time, Expert collaborated and interfaced with external clients.
She also worked collaboratively with Project Managers, the Engineering Department, Operations and QA.

Career Accomplishments

Associations / Societies
American Chemical Society (ACS), 25 years
American Association of Pharmaceutical Scientists (AAPS)
Regulatory Affairs Professionals Society (RAPS)
Publications and Patents Summary
Expert has one patent (formulations).

She has given 3 presentations via AAPS.

Language Skills

Language Proficiency
English Fluent
Spanish Fluent
Polish Fluent
French Conversant
German Conversant

Fields of Expertise

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