Company: MDCXW
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001062993-25-006485
Chunk: 15

Company: Medicus Pharma Ltd.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1
Chunk 15
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 sufficient to deliver the drug payload
                     
                    Demonstrated in vitro, ex vivo, and in vivo.

                    Doxorubicin stability
                     
                    pH measurement of the solution prior to carboxymethyl cellulose ("CMC") addition; follow-up analytical testing for impurities

MNA = dissolvable microneedle array, HPLC = high power liquid chromatography, UV = ultra-violet, CMC = carboxymethyl cellulose.

Manufacturers of D-MNA Components

                    API/Excipient
                     
                    Manufacturer/Lot Number

                    Doxorubicin HCl
                     
                    Gemini PharmChem, Mannheim, GmbH, batch no. 070520

                    Citric acid anhydrous
                     
                    Fischer Scientific/185791

                    Sodium phosphate dibasic anhydrous
                     
                    Fischer Scientific/175060

                    Trehalose dihydrate
                     
                    Pfanstiehl/37108A

                    Carboxymethyl cellulose
                     
                    Dow distr. By aic, Inc./F294F88017Spectrum Chemical Mfg. Inc./ 2JA0070

                    USP purified water
                     
                    Millipore/F7PA35615

                13

Composition of the Drug Product

Each array contains 400 microneedles with a total tip volume of 9.6 µL which are evenly filled with 9.6 µL of doxorubicin gel of the following composition. The doses in the headline refer to the base of doxorubicin. The current formulation contains an overage of 5% of drug substance.

Controls of Critical Steps and Intermediates

The following are fundamental to the production of arrays according to GFE Protocol P171016-1-R3.

• Preparation: Assembly and gel formulation.

• Deposition 1 (Tip Loading): Deposition of the formulation containing active doxorubicin and excipients.

• Deposition 2 (Backing Plate): Deposition of formulation containing only excipients to create the backing plate to the needle structure.

• Drying: Centrifugation of the array under controlled temperature and humidity conditions until moisture is removed from the formulation.

• Demolding, Cutting, Desiccation, and Storage: Removal of the arrays from the molds, trimming, and storage in a desiccator box in a controlled refrigerated environment for 72-96 hours.

Critical to quality parameters