imad Nour

• Formulation development as per quality by design guideline (using DSC, TGA and XRPD) by identifying quality target profile and critical quality profile including risk assessment.
• Analytical development as per quality by design guideline (using NMR, FTIR, HPLC & GC/MS) by identifying analytical target profile and critical method parameters including design of experiment (validation and verification).
• Emulsion preparation to control formulation parameters such as CMT, cloud point and HLB.
• Formulation of nanoparticles for targeted drug delivery by pressure cell.

• Designed APAP development study elements such as critical attributes (CQA, CMA and CPP), quality target profile (form, strength, and stability) critical quality attributes (physical, assay and micro) and risk assessment (compounding, drying, and packaging).
• Developed solution dosage (with CD) and suspension dosage (with wax) for Famotidine formulations.
• Reformulated Aquatic suspension dosage (with PEG) and oily suspension dosage (with lecithin) for Cough Cold formulations.

• Created new method for making Targeted Delivery soft gel capsules formulation that does not require the use of surfactant and is only prepared from phospholipids.

• Used solid dispersion method (crystal engineering) to increase the solubility of APAP by dissolving it with polymer and then removing the solvent by rotary evaporation.

• Wrote study protocol and report of leachable contaminants extracted from hoses during manufacturing as requested by FDA.

• Suggested methods to increase the stability of gel capsule under with acidic fill by adding cellulose, with aquatic fill by adding gum and with alcoholic fill (PG) by adding HPMC.

• Worked on technology transfer process including Bench mix trials, RM and FP specs, stability study and MBPR beside writing technology transfer protocol and report.

• Wrote Nitrosamine studies for different products according to FDA guidelines.

• Shared in research to formulate docetaxel and tadalafil with tween and suggested using Albumin in the formulation.

• Prepared tablet in capsule to target different areas in the body.

• Increased the bioavailability of the medicine by using monoglyceride with ethyl ester instead of triglyceride.

• Solved different types of problems such as:

-Getting hazy solution: Changed to different PVP in the fill and different solvent in the gel.

-Higher viscosity: compensated lost water.

-API precipitation: changed PVP type and pH.

-Capsule is large size: changed from solution to suspension and changed gel composition to be resistant to acidic and alcoholic gel.

-Unstable API: Coated the API with polymer and contain it in CD.

-Glycerin migrated to gel shell: replaced with PG as it is less attractive to shell.

-Cremophor caused allergy in Docetaxel: replaced with albumin.

-Bismuth subsalicylate issues: added buffer to control charged around particle and to control flocculation.

-Phenylephrine degradation: tried CD inclusion method as first option and adding MCC (microencapsulation) as second option.

GMP  and GLP training.