Topical pharmaceutical product formulations can be used to treat local and systematic indications. They offer ease of delivery, facilitate patient compliance, and avoid the problem of the first-pass metabolism. These topical formulations may be liquids, creams, gels, or other semisolid forms. Successfully developing a topical formulation requires an understanding of the physiochemical properties, such as release characteristics, the composition of the drug-delivery system, and the nature of the drug delivery vehicle.
In addition, organoleptic properties (appearance, feel, scent) may be important. For process development and manufacturing of a semisolid dosage form a CMC strategy must be implemented that ensures not only efficacy, chemical, and physical stability, but a minimization of process impurities.
When it’s impractical or too costly to formulate topical products in-house, Avomeen can handle the entire topical drug production process. As an FDA-registered and GMP-compliant laboratory, we have the advanced instrumentation and skilled team necessary to manufacture even the most complicated topical formulations.
Whether you plan to formulate an entirely new topical product or just need to streamline your current production process, Avomeen has the resources and experience to help.
Topical Drug Production Challenges
Avomeen constantly tackles even the most complex projects, including the formulation of topical gels, creams, emulsions, foams, sprays, and more. We know that the stability and efficacy of your product depend on a number of factors, including mixing method, mixing time, heating and cooling rate, temperature, and even the order the ingredients are added. We’ll utilize equipment that gives us precise control over these factors and develop an optimal manufacturing process for your product.
We also recognize that certain active pharmaceutical ingredients (APIs) can be compromised by environmental factors such as UV light and oxygen. We can identify potential degradation problems and develop a topical formulation that prevents those problems, ensuring that your product remains safe and effective for your customers.
Processing and Production Capabilities
At Avomeen, we have the capabilities to formulate, test, and manufacture topical products. Some of the topical product formulation and manufacturing services we offer include:
- In Vitro Release Testing (IVRT) & In Vitro Permeation Test (IVPT)
- Liquid, Cream & Gel Manufacturing
- Novel formulation development or existing formulation optimization
- Controlled substances (Schedule I – V)
- Identification and optimization of critical process parameters, using DOE when appropriate
- Development and implement process controls using Quality by Design to streamline pre-market approval
- High and low shear homogenization
- Semi-automated vial, bottle, tube filling
- Laboratory & pilot batches to scale-ups & technology transfer
- Temperature controls
- Variable speed mixing
- Double-sided agitation
- Blending & granulation
- Trial runs on new products
- cGMP batch sizes (1 to 20 L)