Topical development focuses on semi-solid dosage forms designed to be administered directly to the site where treatment is needed such as the skin, ears, or mucosal surfaces. According to the U.S. Food and Drug Administration, topical drug products are intended to deliver local therapeutic effects at or near the site of application, while in some cases allowing for systemic absorption. Topicals can treat a range of conditions including infections, inflammation, skin disorders, and even some systemic conditions via absorption of the active pharmaceutical ingredients (APIs) through the skin.
Forms of topical medications include creams, ointments, oils, and lotions. Each form has its own set of characteristics that influence not only how a product feels, but also how it delivers its active ingredients. In some cases, several different forms of a topical can be formulated from the same API (e.g., a liquid solution, ointment, or cream) to match differing patient preferences and dosing goals.
At LGM Pharma, our semi-solid manufacturing capabilities support a range of products encompassing prescription medications, over-the-counter treatments (OTC), and cosmetics. Across a range of applications, LGM has the expertise and capabilities to match active pharmaceutical ingredients with the right excipients to achieve the consistency, stability, and performance our partners demand for their topical pharmaceuticals.
Scaling Topical Development from Clinical to Commercial Manufacturing
An important aspect of LGM’s topical formulation services is our ability to work with our partners starting with the small batches needed for clinical trials through full commercial scale up. Whether it is a few liters or 12,000 liters, we have the expertise to guide product development through its entire journey to market.
All topical products, whether small clinical batches or large commercial runs, are manufactured under strict cGMP standards if intended for human use. Our systems ensure consistent quality and compliance at every stage. With batch sizes ranging from 1,000 to 12,000 liters, we provide the capacity to support development, scale-up, and market readiness.
Engineering batches are a vital step in scaling to commercial production. These test runs confirm that the formulation meets specifications and remains consistent at larger volumes. Depending on client needs, they can be produced under either non-GMP or cGMP conditions. When manufactured under cGMP and meeting all requirements, engineering batches may also be released for commercial use.
Working through a staged approach starting in the clinic with small batches, moving to validation of the process in intermediate batches, to full-scale production, allows LGM and our partners to optimize production parameters to avoid late surprises and confirm that our Critical Process Parameters are finetuned for each formulation and active pharmaceutical ingredient (API).
Semi-Solid Manufacturing, Packaging, and Labeling
At LGM Pharma, successful topical development relies on experienced integration of formulation, manufacturing, and packaging—each with distinct technical requirements.
Formulation of Topical Products
Formulation begins with the selection of excipients based on Critical Material Attributes (CMAs), aligned with the API’s properties and the desired consistency of the finished product. Manufacturing feasibility is a top priority from the start by considering Critical Process Parameters (CPPs) that influence scale-up.
Packaging Considerations
Production relies on jacketed mixing tanks that precisely heat or cool ingredients to achieve the right viscosity, stability, and uniformity. Depending on the formulation, mixing may involve stirrers, homogenizers, or high-shear agitators for optimal blending.
Once mixed, the product moves to filling and packaging. In contrast to solid-dose forms, topical drugs have a wider range of packaging options—tubes (metal or plastic), jars, bottles, vials, and spray containers—all with different closure systems. Each packaging type has specific requirements for fill volume, equipment compatibility, and user experience. LGM works closely with clients to clarify packaging details early, minimizing downstream bottlenecks.
Material compatibility is also essential. Packaging must shield the formulation from air, light, and moisture, and must not interact with the product. We conduct extractables and leachables studies, stability testing, and dose-delivery assessments for formats like sprays and droppers to ensure integrity and regulatory compliance.
For dosage-sensitive formats like sprays or droppers, additional controls are required. LGM performs spray pattern and dose uniformity testing to verify that each actuation delivers the correct amount of drug. These tests are especially important for regulatory compliance and therapeutic consistency.
Labeling Capabilities
Our in-house labeling team adds further value by supporting artwork design, format validation, and print vendor coordination. From clinical through commercial scale, we help customers navigate label placement, carton compatibility, and serialization requirements. This attention to detail prevents delays and ensures readiness for launch.
By combining formulation expertise, advanced manufacturing capabilities, and end-to-end packaging support, LGM Pharma delivers topical products that are consistent, compliant, and ready for market.
Ensuring Quality and Consistency of Topical Pharmaceuticals
At LGM Pharma, quality is embedded into every stage of topical manufacturing under strict adherence to cGMP guidelines. From raw material intake through final packaging, our processes are designed to ensure consistency, safety, and compliance.
Raw Materials and Production Oversight
We begin by qualifying suppliers and testing all incoming materials to verify identity, purity, and other critical attributes. Production follows approved master batch records, developed with a Quality by Design (QbD) approach that defines critical material attributes (CMAs) and critical process parameters (CPPs) from the outset. Each stage is documented and reviewed by trained staff to ensure traceability and process control.
In-Process and Final Testing
Throughout manufacturing, we perform in-process tests—such as viscosity, pH, and appearance—to confirm formulation quality before filling. Once in packaging, we verify fill volumes, conduct statistical checks, and test specialized formats (like sprays or tubes) for dosing accuracy and functional integrity.
Integrated Quality Oversight
Throughout the process, three core teams work in parallel:
- Operations for manufacturing and packaging
- Quality Control (QC) for testing raw materials, in-process samples, and final product
- Quality Assurance (QA) for oversight, record review, and final release
At its core, this commitment to quality is driven by a robust quality management system—a comprehensive set of policies, procedures, training, and continuous improvement practices that guide everything we do.
A Trusted Topical CDMO Partner
At LGM Pharma, we bring deep formulation expertise, integrated capabilities, and a commitment to seeing complex topical products through to commercialization. From challenging semi-solid formulations to unconventional packaging needs, we take on projects’ others might walk away from.
With integrated services spanning formulation, scale-up, manufacturing, packaging, and labeling, development stays streamlined under one roof. Supported by collaborative teams and responsive project management, clients can progress from concept to market faster—without sacrificing quality.
Interested in learning more about our topical development and semi-solid manufacturing capabilities? Connect with our team today.
Frequently Asked Questions
- What is topical development in pharmaceutical manufacturing?
Topical development refers to the formulation, testing, and scale-up of semi-solid and liquid dosage forms designed for localized application to the skin or mucosal surfaces. This includes selecting appropriate APIs and excipients, optimizing viscosity and absorption, and ensuring stability, safety, and regulatory compliance throughout development. - How do topical products move from clinical to commercial production?
Topical products typically begin with small clinical batches for initial studies, then progress through engineering and validation batches before reaching full commercial scale. Each phase confirms that the formulation performs consistently, meets specifications, and can be reliably manufactured at larger volumes. - What types of packaging are available for topical pharmaceuticals?
Topical products can be packaged in a wide range of formats including tubes, jars, bottles, vials, and spray containers. Each option has unique requirements for material compatibility, fill accuracy, dose uniformity, and user experience, all of which must be addressed during topical development. - What quality testing is required for topical drug products?
Quality testing includes raw material testing, in-process checks such as pH and viscosity, fill volume verification, dose uniformity for sprays or droppers, and stability testing. These controls help ensure consistent potency, safety, and regulatory compliance from development through commercialization. - Why is working with an experienced topical CDMO important?
An experienced topical CDMO provides the technical expertise, regulatory knowledge, and scalable manufacturing infrastructure needed to successfully guide products from formulation through commercial launch. This reduces development risk, improves efficiency, and helps ensure long-term product quality and supply reliability.