Customized Lipid Microparticles System Services

Solid lipid microparticles (SLM) are a kind of micro-sized drug delivery system with good biocompatibility and effective drug release control, using lipid materials with high melting point as carriers. SLMs are complex multiphase systems, and their formulation composition and preparation process determine the microstructure of SLMs, which in turn affects their final performance. CD Formulation provides a full range of drug development solutions for our customers, such as formulation development and customization services.

Lipid Particle Preparation Technology

• Melt Dispersion Technology

Melt dispersion technology is used for SLM formulations, which can be obtained from O/W or multiple W/O/W emulsions, depending on the chemical properties of the drug. In the case of O/W precursors, the lipophilic drug is dissolved into the molten lipid and emulsified with a hot surfactant solution in water using a high shear mixer. The lipid particles are then cured by cooling at room temperature.

• Cryogenic micronization technology

In cryogenic micronization, lipid substrates obtained by melt dispersion or solvent stripping are stored at low temperatures and then micronized in custom equipment under the action of liquid nitrogen to prepare lipid particles.

• Spray drying technology

Spray drying of lipid particles is performed using an organic solvent solution as the feed material. The solution is evaporated into dry particle form in a one-step process.

• Spray Coagulation Technology

In the spray coagulation method, the lipids are heated to a temperature above their melting point. The hot lipid is atomized by means of a pneumatic nozzle into a container, which is kept in a CO₂ ice bath. The obtained particles are then dried under vacuum at room temperature.

Customization of Lipid Microparticles

CD Formulation's pharmacological experts offer you the development of SLM formulations and the optimization of the preparation process. We are equipped with a specialized laboratory to analyze the trends affecting the average SLM particle size, particle size distribution and drug encapsulation rate, as well as the changes in the SLM microstructure during the process, and to optimize the SLM preparation process conditions.

Solid Lipid Particle Characterization

• Size and morphology

The size distribution of SLM was assessed by sieve analysis using a shaker and a standard sieve. The shape and surface morphology of SLMs were evaluated by scanning electron microscopy (SEM).

• Hot Stage Microscopy (HSM) Analysis

Physical changes in the sample during heating are monitored by the HSM using a hot-stage device, which is mounted on an attached optical microscope for image acquisition.

Characterization of drug molecules after encapsulation

• Raman Spectroscopy

Raman spectra were obtained on a micro Raman spectrometer equipped with a microscope.

• Fourier transform infrared spectroscopy

Infrared spectra were analyzed by an infrared spectrometer using the potassium bromide disc method.

• Evaluation of drug molecules after encapsulation

In order to measure the activity of the loaded drug molecule SLM, the lipid matrix must be dissolved and the substance to be measured released. Preliminary experiments were performed to find a suitable solvent to dissolve the SLM without affecting the drug molecule activity. SLM was dissolved in methylene chloride or other solvents, and after complete dissolution, a phosphate buffer was added and the two immiscible phases were shaken. Then, an aliquot of this solution was used for activity determination. The free drug molecules and physical mixture were tested to verify the efficiency of the extraction process.

• In vitro release studies

In vitro release studies were carried out by simulating the environment at the site of exerting the drug effect.

With years of experience in the field of novel drug delivery system studies, CD Formulation offers a range of custom lipid-based drug delivery formulations to help improve our clients' projects. If you have a need for our services, please feel free to contact us.