Cream Development Services
Creams are semi-solid dosage forms widely used for topical applications. They consist of a mixture of oil and water as well as other ingredients such as emulsifiers, thickeners, preservatives and active pharmaceutical ingredients (APIs). The form of cream formulations effectively delivers the API directly to the desired site.
Protheragen-ING is an expert in the formulation development of pharmaceutical formulations and provides a one-stop service for cream formulation development based on the characteristics of the API and the development goals of the client.
Advantages of Cream Formulations
- Easy to apply and absorb - Creams have a soft texture and spread easily on the skin, facilitating drug penetration and absorption.
- Topical effect - Creams are mainly used for topical treatment and are applied only to the affected area, reducing the impact on other parts of the body.
- Moisturizing effect - The base agent in the cream usually contains moisturizing ingredients that help keep the skin moisturized.
- Multiple medication options - Pharmaceutical creams can be used with different medication ingredients to achieve therapeutic results depending on the specific condition.
Types of Cream Preparations
Protheragen-ING offers development services for the following two types of creams:
The product can be either water-in-oil (w/o) or oil-in-water (o/w), consisting of waxes, emollients, and lubricants dispersed in an oil phase, or an aqueous phase containing emulsifiers, stabilizers and thickeners, preservatives and colorants, where the active ingredient is added after the emulsion has been formed and cooled to shape.
This product is a cream prepared without aqueous phase materials in the cream preparation system, which is characterized by lubricity, non-irritation, and the ability to seal the skin surface, reduce water evaporation, and promote skin hydration.
General Process Flow of Creams
Pharmaceutical creams
1. Preparation of the oil phase
The powder components are dispersed into mineral oil or silicone oil, which needs to be heated to dissolve.
2. Preparation of the aqueous phase
Emulsifiers, thickeners, stabilizers, etc. are dispersed in an aqueous phase tank and heated to do premixing.
3. Formation of the emulsion
The oil and water phases are mixed to form a stable and homogeneous emulsion under suitable techniques (e.g. high shear mixing, homogenization, or ultrasound).
4. Dispersion of the active ingredient
The active ingredient is usually a small percentage of the formulation and needs to be effectively dispersed throughout the system.
Fig. 1 Structure of the common type of enteric hard capsule (Snap-fit type): (A) open position with two capsule parts (cap, body); (B) pre-closed position; (C) closed position of hard capsule. (Franc A, et al. 2022)
Creams for anhydrous systems
1. Separate premixing of two oil phase materials.
2. Two oil phase materials are added to the mixing tank for forced mixing and homogenization.
More Cream Development Solutions
In addition to formulation development, Protheragen-ING offers the following cream development-related services to support our client's drug development needs.
| Preformulation Studies |
Evaluation of the physicochemical properties of APIs and excipients, including solubility studies, compatibility studies, and determination of pH range for optimal stability. |
| Rheological Evaluations |
Evaluations include assessing the flow properties of creams to determine viscosity, consistency and spreadability. This helps to evaluate texture and ease of use. |
| Stability Testing |
Creams are subjected to a variety of conditions such as temperature, humidity, and light to assess their physical, chemical and microbiological stability. |
| Packaging Compatibility |
Evaluates the interaction between the cream and packaging materials to aid in packaging material selection. |
| Safety and Efficacy Assessment |
This may involve in vitro studies, such as skin penetration studies, and in vivo studies, such as skin irritation testing or clinical trials. |
| Regulatory support |
This involves preparing the necessary documentation, such as drug master file (DMF) or new drug application (NDA), and complying with regulatory guidelines and requirements. |
If you are interested in our cream formulation development services, please contact us for detailed information and services.
