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Pharmaceutical creams and ointments are mostly used for the treatment of different skin problems, such as rashes, skin irritation, stings, fungal infections, etc. Unlike cosmetic skincare products, pharmaceutical creams are required to contain 99% of pure active ingredients, such as various Vitamins and Peptides as these are meant to penetrate deep into the skin to reach targeted cells and make a difference in the skin. Cosmetics creams and lotions only work on the epidermis, the outermost layer of the skin. Therefore, the active ingredients added to cosmetics products may be similar to ingredients found in pharmaceutical creams but are used in smaller concentrations.
Production processes for making creams and ointments
Mixing is a critical stage in obtaining fine droplet size to form a stable emulsion and the right cream consistency. Ingredients, formulation and viscosity vary per product. However, a typical manufacturing process to create either a cream or ointment breaks down into four steps: Oil phase preparation, Water phase preparation, Forming the emulsion and Active ingredients dispersion.
Solid waxes, emollients and lubricants need to be dispersed into mineral or silicone oil. Heating might be required to melt some ingredients like waxes. Emulsifying, stabilizing and thickening agents are added and dispersed into a separate vessel with water. Hydration can be accelerated by additional heating. Prepared oil needs to be added to a water substance. The two phases need to be blended under strong agitation to form the emulsion. Active ingredients are also added in either phase and must be efficiently dispersed to achieve smooth consistency and texture of the cream.
High shear mixer vs conventional aerator
Mixing high viscosity and greasy pharmaceutical creams and ointments is a very challenging process. Using standard mixer like conventional agitator to incorporate powders into liquids and create a homogeneous and fine emulsion can cause several problems. One of them would be the formation of agglomerates which could lead to a longer mixing time due to difficulties in hydrating the thickeners.
High shear mixing is a preferred solution to use for creams and ointments. These are available for both batch or continuous processes and can eliminate intermediate stages of production that dramatically reduce the processing time. As shown in the video below, high shear mixer makes sure that the thickening agents are fully hydrated and other ingredients fully dispersed, which forms a stable emulsion in shorter period of time.
Creams as emulsions can be relatively unstable, which requires to create an effective formulation through the careful selection of the correct excipients. Excipients allow to prevent the formulation instability and extend the product shelf life. Some of them include preservatives, emollients, emulsifiers, viscosity modifiers, solvents. Excipients can mix together to result the molecules organize on a microscopic scale and build structure in the formulation, called microstructure.
The creams with the right formulation are easy to apply and don’t leave much residue. Ideal formulation doesn’t make the cream greasy and creates the right texture, without large crystals that may result in skin irritation. Moreover, the right formulation should provide a proper dermal drug delivery into skin, which shows that the active ingredient being incorporated effectively.
Packing of creams and ointments
When filling topical formulations it is essential to get the amount of product in various consistencies per container just right and to be able to accommodate various container shapes and sizes. There are many factors that influence the decision for choosing a container to fill in topical dosage forms. Some of these factors are materials and visual appearance while others are specific to the usage of the product filled. The most common containers for filling creams are tubes and glass or plastic jars.
Tubes have narrow openings that protect the creams against contamination and preserves the product’s shelf life. Tubes are mostly made from low or high-density polyethylene and aluminum. They have various top shapes that can be applied. For example, triangular toppers allow to push out as much product as needed with precision. Push tops are also common for creams that need controlled amounts produced with each pump. Tubes can be of different diameters ranging from 16mm to 50mm and the capacity ranging from 5ml to 240ml.
What is the equipment used in improving the consistency of cosmetic creams?
A cream mixer is designed for mixing thick body cream mixtures and other skincare products with a viscous body. Industrial grade mixers improve the particle size and consistency of creams by managing mixing times and reaction rates. Propeller mixers perform high shear mixing through homogenization, emulsification, and blending cosmetic cream ingredients into a consistent, viscous cream. In contrast, a three-roller mix can improve the consistency of creams by minimizing the reduction rate.