Zelmic · Topical Formulation Development
Topical formulation development is the design and optimization of medicines applied to the skin so that the active ingredient stays stable, is well tolerated, and reaches its site of action. For complex products — multiple actives, sensitive molecules, or tight equivalence targets — it is as much an analytical and performance-testing challenge as a formulation one.
Zelmic develops semisolid and liquid dosage forms, and, for early clinical work, oral forms too:
Creams, ointments, gels and lotions; suspensions and solutions
Pre-formulation studies, excipient screening and Q1/Q2/Q3 development
Small molecules, peptides, proteins, oligonucleotides and advanced delivery systems
Stability-indicating analytical methods and stability studies
A continuous path into EU GMP manufacturing and clinical supply
Topical formulation development is the design and optimization of medicines applied to the skin — such as creams, ointments, gels and lotions — so that the active ingredient is stable, well tolerated and delivered effectively to its site of action. It spans pre-formulation and excipient screening, prototype development, stability testing and scale-up toward GMP manufacture.
A topical CDMO typically develops semisolid and liquid dosage forms including creams, ointments, gels, lotions, suspensions and solutions, and in some cases oral dosage forms for early clinical studies. Zelmic develops these forms for small molecules, peptides, proteins, oligonucleotides and advanced drug delivery systems.
In topical generic development, Q1 means a product has the same components as the reference product, Q2 means the same components at the same concentrations, and Q3 means the same arrangement of matter — comparable microstructure and physical properties. Q3 is often the hardest to match and is characterized using methods such as IVRT, IVPT and microstructure or particle analysis.
For a generic, the goal is to match the reference product’s qualitative and quantitative composition and microstructure (Q1/Q2/Q3) and to demonstrate equivalence. For an NCE there is no reference product — the work is instead about developing a stable, well-characterised formulation from scratch, optimising skin delivery, and building the CMC package needed for First-in-Human and beyond.
Formulation and performance testing go hand in hand: methods such as IVRT (release) and IVPT (permeation through skin) show how formulation choices affect drug delivery, guiding optimization and supporting regulatory and bioequivalence work. Developing the formulation and the test methods together reduces risk and rework.
Yes. An integrated CRO/CDMO can carry a topical product from pre-formulation through analytical development, GMP manufacturing of the investigational medicinal product (IMP) and QP release for clinical supply. Zelmic provides this continuity in-house and, through the CTR Group, connects to clinical, regulatory and quality partners.
Topical delivery is used for small molecules and, increasingly, for more complex actives such as peptides, proteins and oligonucleotides, each with its own stability and delivery challenges. Matching the formulation to the molecule — protecting sensitive actives and enabling skin penetration — is central to development.
Talk to Zelmic's formulation team about your molecule, target profile and route to clinical supply.