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Topical 101: A Guide to Complex Dermatology Formulation Development
Scientific Team
on July 3rd, 2026
Table of content
1. The Science Behind the Topical Delivery
1.1 Delivery routes: topical, dermal, transdermal
- Topical (surface-level): Target the outer skin layers or skin surface, e.g., to treat fungal infections or rare pathogens on skin.
- Dermal (local effect): The drug penetrates the epidermis or dermis to treat conditions like psoriasis, eczema, or localized inflammation. Minimal systemic exposure is acceptable or desired.
- Transdermal (systemic delivery): The drug must cross the skin barrier and reach systemic circulation, often to deliver drugs chronically while avoiding injections or oral metabolism.
1.2 Key Trends Topical Sponsors Can't Afford to Miss
The topical drug development space is undergoing rapid transformation, driven by delivery route strategies that respond to patient expectations, regulatory demands, and technological advances. These shifts are influencing how companies approach formulation, testing, and commercialization.
- Regulatory scrutiny: Dermal absorption can lead to systemic exposure, which may increase regulatory requirements focused on ensuring safety and generating robust pharmacokinetic data.
- Leadership in semi-solid formulations: In 2024, semi-solid products captured 61.9% of drug market revenue, driven by their versatility, ease of application, and effectiveness in delivering active ingredients directly to the skin.
- Dominance of dermal delivery: Dermal drug delivery accounted for 54.1% of the topical drugs market in 2024, supported by its targeted treatment capabilities, user-friendly application, and enhanced patient compliance.
2. Dermatology formulation: the right vehicle for the right api
Whether the formulation is semi-solid or liquid, the choice of vehicle plays a critical role in delivering the API effectively and supporting consistent patient use.
Table 1. Common Semi-Solid Vehicles and Their Role
| Vehicle | Usage Example | Key Strenght | Main Challenge |
| Creams | Antifungal creams, anti-analgesic creams, anti-acne cream |
|
Less occlusive than ointments, emulsion-making
|
| Gels | Anti-acne gel, pain relief gel, transdermal gel, scalp conditions |
|
Limited occlusivity, stability issues
|
| Pastes | Diaper rash, protective barriers | Strong adhesion, protective film, reduced irritation, high occlusiveness |
|
| Lotion | Large surface areas, scalp lotion, antiseptic lotion, anti-inflammatory lotion |
|
|
| Ointments | Psoriasis, chronic dry skin, eczema, burns, dermatitis |
Occlusive, maximizes hydration
|
Greasy feel reduces compliance
|
💡Case Example: In alopecia treatment, a 2025 study found that compounded topical minoxidil formulations led to better adherence and outcomes compared with standard over-the-counter versions, showing how formulation design directly impacts patient success.
3. key factors in developing a successful topical formulation
3.1 Smart Excipient Selection
▪️Vehicle: Dictates cosmetic feel, stability, and patient preference.
▪️API-Excipient Interactions: Poor compatibility can lead to crystallization, loss of potency, or instability.
3.2 Regulatory Compliance and Quality
- A 2024 multicenter study in Egypt found that adherence to topical therapy was significantly lower than to systemic therapy, largely due to regimen complexity and poor cosmetic acceptability.
- Earlier this year, Drug Topics highlighted how low adherence in dermatological conditions such as psoriasis, acne, and atopic dermatitis contributes to suboptimal outcomes and diminished quality of life. Treatment complexity and cost were identified as key drivers of this issue.
3.4 Scalability and Tech Transfer
For all products, scaling up from lab-scale batches to commercial manufacturing is a pivotal moment, one that can expose gaps in process robustness, equipment compatibility, and regulatory readiness.
For those who choose to work with a CDMO, success depends on finding a partner with proven expertise in scalability and tech transfer.
An experienced CDMO should offer:
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Expertise in scaling semi-solid processes, including homogenization and particle size control.
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Experience in tech transfer across R&D, clinical, and commercial phases, ideally with these functions integrated at a single site to ensure smoother transitions.
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Automation capabilities that support consistent batch quality and reduce variability.
At Groupe PARIMA, for example, our facility is purpose-built with great flexibility in annual volumes, from very small to larger-size production (2,000– >1,000,000 units/year), filling a niche for innovators who require their partner to adjust to their evolving needs.
4. From Tropical 101 to your next breakthrough
Effective topical formulation development requires a multidimensional approach that considers the intrinsic properties and limitations of the API, the functional properties of the vehicle, patient safety and acceptability, and the evolving requirements of regulatory agencies.
These formulations require scientific precision, regulatory foresight, and patient-centered design. In this article, we have seen that:
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Topical, dermal, and transdermal delivery each present unique hurdles.
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Formulation types must have a balance between patient adherence, stability, and efficacy.
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Regulatory compliance often hinges on stability and excipient compatibility data.
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Adherence challenges to FDA rejections regarding quality issues underscore the need for strong partnerships with specialized CDMOs.
It expands on regulatory pathways, QbD approaches, and case studies of successful tech transfers in dermatology.
The opportunity is clear: the global market is expanding, but regulatory pressure and patient expectations are rising in parallel. Sponsors who anticipate these challenges are better positioned for success.
To get more insights into case studies, regulatory overview, and technical strategies, stay connected for our upcoming resources, designed for teams that want to move beyond the basics and into development strategies that withstand real-world analysis.
Scientific Team
on July 3rd, 2026
Our Scientific Team combines the expertise of formulation scientists, process engineers, and analytical specialists who contribute their knowledge to advance pharmaceutical drug development. Articles are curated by our marketing and communications department in collaboration with subject-matter experts.