Proteins & Peptides Microemulsion Delivery System Development

Microemulsions, a thermodynamically stable colloidal dispersion, have become an attractive delivery system for therapeutic proteins and peptides due to their ability to enhance bioavailability. With decades of successful project experience and expertise in the development of microemulsion delivery systems, CD Formulation excels in developing various microemulsion delivery systems, such as self-emulsifying drug delivery systems (SEDDS) and self-nano-emulsifying drug delivery systems (SNEDDS) to enhance the delivery of proteins/peptides to meet specific formulation requirements and optimize drug release profiles.

Potential Advantages of Microemulsion Delivery of Protein/Peptide

Microemulsions (ME) are isotropic mixtures with or without co-surfactants, and combinations of oil, water, and surfactants, which are most stable from a thermodynamic point of view. As potential drug carrier systems for various routes of administration of biomacromolecules such as proteins/peptides, they have the following advantages over other dosage forms.

• They are thermodynamically stable and require minimal energy to form.
• Easy to manufacture and scale up.
• Improved drug solubility and bioavailability.
• Drug targeting and controlled release.

Fig. 1 General structure of microemulsion. (CD Formulation)

Explore Our Proteins & Peptides Microemulsion Delivery System Development Services

As an expert in protein/peptide science and formulation science, CD Formulation has the most advanced industry knowledge and technology in protein/peptide delivery and is committed to providing you with comprehensive, innovative, and efficient microemulsion delivery system development solutions.

As the structure of microemulsions is extremely unstable and diverse, the structural characteristics of microemulsions are much more complex and diverse than those of macroemulsions. Our scientists will conduct a thorough phase behavior study based on the characteristics of your product to design and develop the best microemulsion formulation for you.

We usually use the following methods to embed your protein/peptide into the emulsion.

1) The injection method, introduces the protein/ solution into the surfactant solution in a non-polar organic solvent. The resulting mixture is shaken vigorously until an optically clear, delicate, and transparent solution is obtained.

2) The dry lyophilized protein is added to the surfactant solution in the organic solvent containing the aqueous phase.

3) Gently shaking equal volumes of the protein aqueous solution and the organic solvent containing the surfactant, causing the protein/peptide to be incorporated into the reverse micelles of the organic phase.

In addition, we also use ultrasonic irradiation and a jet generator to obtain a stable emulsion with a narrow distribution of dispersed phase droplets.

Our Solutions for Proteins & Peptides Microemulsion Delivery System Development

The design and formulation of protein/peptide microemulsion systems should comprehensively consider formulation strategies and delivery strategies to achieve optimal stability, biocompatibility, targeting, and thus maximize bioavailability.

Formulation Strategy

• Aqueous phase: For parenteral microemulsions, the aqueous phase must be isotonic with the blood. Our scientists achieve this by using additives such as electrolytes (sodium chloride), sorbitol, glucose, and glycerol.
• Oil phase: Our oil phase selection principle is that lipophilic proteins/peptides are highly soluble in them, thereby minimizing the volume of the formulation and providing the required dose of therapeutic drugs in capsule form.
• Surfactant selection: Our scientists screen and test different surfactants, including anionic surfactants, cationic surfactants, and non-ionic surfactants, and comprehensively consider factors such as the permeability, foaming, cleanliness, and compatibility of the surfactants.

Delivery System Strategy

Fig. 2 Proteins/peptides microemulsion delivery system strategy.(CD Formulation)

• Self-Emulsifying Drug Delivery Systems (SEDDS)

This system has lipid excipients that can improve the solubility and permeability of the drug. These lipid excipients emulsify when exposed to gastrointestinal fluids to form water-in-oil emulsions or microemulsions. By considering the sphere size, we can develop self-microemulsifying drug delivery systems (SMEDDS) and self-nanoemulsifying drug delivery systems (SNEDDS).

• Self-Nano-Emulsifying Drug Delivery Systems (SNEDDS)

This system is mainly used to deliver protein drugs via oral route, since it does not contain water, it can maintain protein stability for a long time, protect proteins from proteolytic degradation, and enhance the permeability of therapeutic protein drugs in the gastrointestinal tract.

• Convertible/ Phase Reversible Microemulsion

This microemulsion system can freely phase-convert to oil-in-water (o/w) emulsion. Our scientists use short-chain monoglyceride surfactants as a reservoir for proteins, making them stable for a longer time at room temperature and above until they can be used in w/o microemulsions. Within a specific time period, adding an aqueous fluid sample converts the microemulsion into an oil-in-water emulsion, releasing the therapeutic protein/peptide.

• Microemulsions with Adsorbed Macromolecules and Microparticles

Our scientists use various types of biocompatible and biodegradable polymers, such as polycaprolactones, polyorthoesters, polyanhydrides (including poly(α-hydroxy acids) and polyhydroxybutyric acid), with proteins/peptides and metabolizable oils and emulsifiers to prepare microemulsions containing adsorbed macromolecules and microparticles.

Supporting Microemulsion Analysis and Testing Services

We offer a full range of analytical testing capabilities to support the development and manufacturing of microemulsion formulations and delivery systems. All of our analytical testing capabilities can be performed in-house by our team, allowing for rapid results and close interaction between the formulation and analytical teams.

The full range of analytical testing capabilities we offer is listed below:

• Clarity Testing: UV-Vis Spectrophotometer.
• Conductivity and pH: Conductivity meter and pH meter. This helps determine if the system is oil-continuous, bicontinuous, or water-continuous.
• Viscosity: Brookfield Viscometer
• Particle Size and Zeta Potential Measurements: Dynamic light scattering
• In Vitro Release Kinetics: Determines the permeability of drugs in microemulsions across cell membranes using a Franz diffusion apparatus.

Why Choose Us for Proteins & Peptides Microemulsion Delivery System Development?

• Extensive expertise and experience in executing protein/peptide microemulsion delivery system development.
• We have a flexible team of experts responsible for formulation feasibility, process development, and commercial manufacturing.
• Comprehensive analytical testing capabilities, including evaluation of drug release performance, stability, and biocompatibility.
• Establish partnerships with pharmaceutical companies and research institutions to jointly develop innovative protein/peptide microemulsion delivery systems.
• We provide flexible and tailored solutions to meet our customers' specific needs and requirements.
• Fast and efficient services ensure that our customers' projects are delivered on time.

Publication

CD Formulation is continually researching and developing new technologies to improve protein/peptide microemulsion delivery systems. Our scientists stay up to date on the latest advances in the field to provide innovative solutions that can enhance protein and peptide delivery. Please don't hesitate to contact us if you are interested in our services.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.