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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.