Introduction

Azelaic acid (BeriCos® AZA CAS: 123-99-9) is a saturated dicarboxylic acid that has become an important active ingredient in dermatological and cosmetic formulations. It is widely investigated and used for applications associated with acne-prone skin, uneven skin tone, hyperpigmentation, and inflammatory skin conditions. Commercial topical products commonly use azelaic acid at concentrations ranging from approximately 5% to 20%, with cream and gel systems among the most established dosage forms.

BeriCos® AZA Azelaic acid provides a formulation opportunity for incorporating azelaic acid into modern topical cream systems. From a formulation perspective, successful development requires more than simply dispersing the active ingredient into an emulsion. Azelaic acid  has relatively low water solubility and a high melting point, creating challenges related to solubilization, particle size, physical stability, skin feel, and uniform distribution within the finished product.

This article discusses the key formulation considerations, application possibilities, and development principles for a BeriCos® AZA -based Azelaic acid  cream.

1. Why Azelaic acid  Is an Attractive Cosmetic Active

Azelaic acid  has several properties that make it attractive for multifunctional skin-care products. Its biological activities include antimicrobial, anti-inflammatory, and antimelanogenic effects. Consequently, topical AZA has been studied for acne vulgaris, rosacea, melasma, and post-inflammatory hyperpigmentation.

For cosmetic applications, these properties can translate into product concepts designed to support:

• Acne-prone and blemish-prone skin

• Uneven skin tone

• The appearance of post-inflammatory marks

• Dull or rough-looking skin

• Redness-prone skin

• Overall skin texture and complexion appearance

The performance of azelaic acid is strongly influenced by the formulation vehicle. Research indicates that formulation strategies can be used to improve solubilization, skin deposition, delivery, stability, and tolerability.

2. The Main Formulation Challenge: Azelaic acid  Solubility

One of the most important considerations when developing an AZA cream is its limited aqueous solubility. 

Azelaic acid has a reported aqueous solubility of approximately 2.4 mg/mL at 25 °C and a melting point around 106.5 °C. 

These characteristics make conventional incorporation into an aqueous cream challenging.

Depending on the target formulation, azelaic acid may therefore be incorporated as:

1. A finely dispersed solid phase

2. A partially or substantially solubilized active

3. A combination of dissolved and dispersed AZA

4. An advanced delivery system designed to improve cutaneous deposition

The choice depends on the desired concentration, sensory profile, manufacturing process, regulatory positioning, and stability requirements.

For a commercial cream, control of AZA particle size and dispersion is particularly important. Poor dispersion can lead to sedimentation, grittiness, non-uniform dosing, poor aesthetics, and reduced consumer acceptance.

3. Conceptual BeriCos® AZA Cream Formulation

A typical oil-in-water cream containing BeriCos® AZA Azelaic acid can be designed around several functional components:

Formulation component

BeriCos® AZA

Purified water

Humectant

Emollients

Emulsifier

Fatty alcohol/structuring agent

Rheology modifier

Chelating agent

Preservative system

pH adjuster/buffer

Antioxidant, where appropriate

A useful development target is a cream that combines uniform AZA Azelaic acid distribution, acceptable viscosity, smooth application, low grittiness, good stability, and a pleasant after-feel.

4. Manufacturing Approach

A robust manufacturing process can generally be divided into several stages.

Phase A – Aqueous Phase

Water-soluble ingredients such as humectants, chelating agents, and selected water-soluble polymers can be incorporated into the aqueous phase.

Phase B – Oil Phase

Oil-soluble ingredients, emollients, emulsifiers, and consistency agents are combined and processed according to the requirements of the selected emulsification system.

Phase C – AZA Incorporation

The incorporation strategy for BeriCos® AZA should follow the supplier's technical recommendations.

Particular attention should be paid to:

• AZA particle size

• Dispersion quality

• Addition temperature

• Mixing intensity

• Order of addition

• Homogenization conditions

• Potential interactions with emulsifiers and polymers

If AZA is incorporated predominantly as a dispersed solid, sufficient shear and appropriate rheology are important for maintaining a homogeneous system.

Emulsification The aqueous and oil phases are combined under controlled mixing conditions to produce the desired emulsion structure.

After emulsification, the batch is cooled under controlled agitation. Ingredients that are temperature-sensitive should be incorporated during the appropriate cooling stage. The final product should then be adjusted to the target pH and viscosity before filling.

5. pH Considerations

pH is an important development parameter for an azelaic acid cream because it can influence active-ingredient behavior, preservative performance, polymer viscosity, skin compatibility, and overall formulation stability. The optimum pH should therefore not be selected solely on the basis of the active ingredient. 

It should be established experimentally by evaluating:

• AZA physical stability

• Emulsion stability

• Preservative efficacy

• Polymer compatibility

• Skin compatibility

• Long-term storage stability

A controlled pH is particularly important when combining AZA with other functional ingredients.

6. Application Opportunities

BeriCos® AZA Azelaic acid can be considered for several topical skin-care concepts, subject to the final concentration, formulation, regulatory status, and substantiation of the finished product.

Acne-Prone Skin

Azelaic acid has established dermatological relevance in acne management. Its antimicrobial and anti-inflammatory properties make AZA-containing topical formulations particularly interesting for products targeting blemish-prone skin.

Uneven Skin Tone and Hyperpigmentation

Azelaic acid also has antimelanogenic activity and has been investigated for melasma and post-inflammatory hyperpigmentation. This makes it suitable for cosmetic concepts focused on improving the appearance of uneven pigmentation and promoting a more uniform-looking complexion.

Redness-Prone Skin

The anti-inflammatory properties of AZA have contributed to its use in formulations for inflammatory skin conditions, including rosacea. However, cosmetic claims should be carefully distinguished from therapeutic claims and supported by appropriate evidence.

7. Formulation Performance and Stability Testing

A BeriCos® AZA Azelaic acid cream should undergo comprehensive testing before commercialization.

Important development tests include:

Physical stability

• Appearance

• Color and odor

• Phase separation

• Sedimentation

• Particle/crystal formation

• Viscosity

• pH

Chemical stability

• AZA assay

• Degradation products, where relevant

• Compatibility with other active ingredients

Microbiological quality

• Total microbial count

• Specified microorganisms

• Preservative efficacy/challenge testing, where applicable

Packaging compatibility

• Container interaction

• Changes in viscosity or appearance

• Active-content stability

• Leakage and dispensing performance

Accelerated and long-term stability studies should be conducted using the intended commercial packaging.

8. Sensory Profile

An important advantage of cream formulation is the ability to balance active delivery with consumer comfort.

For an BeriCos® AZA Azelaic acid cream, the desired sensory characteristics may include:

• Smooth and homogeneous texture

• Easy spreadability

• Minimal tackiness

• Low visible residue

• Non-gritty application

• Rapid or comfortable absorption

• Pleasant after-feel

Because BeriCos® AZA Azelaic acid can be challenging to formulate at relatively high concentrations, sensory optimization should be treated as an integral part of formulation development rather than as a final-stage adjustment.

9. Advanced Formulation Strategies

Conventional creams remain important, but newer delivery technologies are being investigated to address the solubility and permeability limitations of azelaic acid.

Research has explored liposomes, niosomes, ethosomes, microemulsions, nanostructured lipid carriers, nanosponges, polymeric systems, and deep eutectic solvent-based approaches. These technologies aim to increase Azelaic acid AZA solubilization, improve skin deposition, enhance stability, or reduce irritation.

For BeriCos® AZA Azelaic acid , such approaches could provide opportunities for developing differentiated products where conventional cream technology does not provide the desired performance.

10. Conclusion

BeriCos® AZA Azelaic acid offers an interesting platform for the development of modern azelaic-acid-based topical creams. The key to successful formulation is controlling the interaction between the active ingredient and the cream vehicle.

Because azelaic acid has limited aqueous solubility and presents formulation challenges, careful selection of the dispersion/solubilization approach, emulsifier system, rheology modifiers, pH, processing conditions, and packaging is essential.

A well-designed BeriCos® AZA Azelaic acid cream can combine the established multifunctionality of azelaic acid with the consumer benefits of a cosmetically elegant topical formulation. Future formulation development may also explore advanced delivery technologies to improve active distribution, skin deposition, stability, and tolerability.

Ultimately, the most successful BeriCos® AZA Azelaic acid formulation should be evaluated not only for active-ingredient content but also for stability, homogeneity, sensory performance, skin compatibility, and demonstrated finished-product efficacy.

If you need more technical documents and trial samples, feel free to contact us.

Elena@zhberi.com  +8619500796925

Azelaic acid  manufacturer - Beri Pharma