Company: MDCXW
Filing Date: 2025-11-19
Form Type: S-1
Source: 0001062993-25-016962
Chunk: 110

Company: Medicus Pharma Ltd.
Filing Date: 2025-11-19
Form: S-1
Chunk 110
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edles 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 |

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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                                  |
| USP purified water                 |     | Millipore/F7PA35615                                |

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 include:

Dissolution and homogeneity of all materials during mixing.

Centrifuge rpm and quality/degree of tip loading.

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Dil