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Proteins & Peptides Injectable Delivery System Development

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Protein/peptide injection delivery, also known as protein/peptide parenteral delivery, is currently the most commonly used method for clinical administration of therapeutic proteins/peptides. As an expert in the development of protein/peptide delivery systems, CD Formulation is committed to assisting our global customers in developing powerful protein/peptide injectable delivery products. Our team of experienced researchers and scientists work closely with our clients to design customized delivery systems that ensure optimal efficacy and safety of protein/peptide therapies.

Potential Advantages for Injectable Delivery of Protein/Peptide

Most protein and peptide drugs on the market are administered parenterally, such as subcutaneous (sc), intramuscular, or intravenous (iv) injection. Compared with oral and pulmonary administration, the potential advantages of parenteral administration include:

  • Avoiding biological barriers and high bioavailability.
  • Directly entering the bloodstream and taking effect quickly
  • Precise dosing.

However, parenteral protein and peptide administration also has several limitations, including:

  • Short half-life.
  • Frequent dosing is required.
  • Poor patient compliance.

Fig. 1 Colloidal carriers for protein and peptide parenteral deliver. Fig. 1 Colloidal carriers for protein and peptide parenteral delivery. (Patel A, et al., 2014)

Explore Our Proteins & Peptides Injectable Delivery System Development Services

CD Formulation is an expert in therapeutic protein/peptide science and formulation science, focusing on combining advanced formulation technology with protein/peptide knowledge to develop first-class protein/peptide injectable delivery systems.

Our scientists deploy a range of strategies, such as nanotechnology, the addition of stabilizing excipients, surface modification, lyophilization technology, and micronization technology to improve the bioavailability and stability of these challenging molecules.

Thanks to decades of experience in protein/peptide delivery system development, we have successfully established a professional injectable platform, focusing on the development and commercialization of various injectable formulations. Our injectable platform is equipped with first-class equipment and cutting-edge nanotechnology to overcome any problems that proteins/peptides may have, such as easy aggregation and degradation, instability, and low bioavailability.

Our protein/peptide injectable delivery system capabilities include:

  • Protein/peptide immediate-release injections.
  • Protein/peptide long-acting injections.
  • Protein/peptide sustained-release injections
  • Protein/peptide controlled release injections.
  • Protein/peptide in situ forming implants.

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

Our Solutions for Proteins & Peptides Injectable Delivery System Development

  • Protein/peptide stability study: We conduct in-depth research on the physical and chemical stability of proteins/peptides to ensure their stability and activity in injection delivery systems.
  • Delivery system design: We design and optimize various delivery systems to ensure that proteins/peptides can be accurately and efficiently delivered to target tissues or cells.
  • Surface modification technology: Through surface modification technology, we can change the biological activity, pharmacokinetics, and immunogenicity of proteins/peptides to achieve better therapeutic effects.
  • Molding technology optimization: We use advanced molding technologies such as microencapsulation, polymer coating, etc. to improve the stability and pharmacokinetic properties of proteins/peptides.
  • Biocompatibility study: We evaluate the biocompatibility of different formulations to the body and select the most suitable formulation for the injection of protein/peptide drugs.

Our Expertise for Proteins & Peptides Injectable Delivery System

  • Characterization of therapeutic proteins/peptides.
  • Protein/peptide stabilization studies, including the addition of stabilizing excipients, pH adjustment, protein/peptide PEGylation, protein/peptide mannosylation, etc.
  • Stability studies, including conventional stability according to ICH, freeze-thaw and thermal cycle stability, photostability studies, reconstitution and dilution stability, etc.
  • Manufacturing process development, including studying packaging material compatibility and evaluating various sterilization techniques and their effects on the product.
  • Sterility testing.
  • Aseptic filling.
  • Lyophilization process development.
  • From laboratory scale-up to pilot to commercialization.
  • Analytical methods and process transfer.

Our Technology Platforms

Technologies Description
Liposome Technology Protein/peptide drugs are encapsulated in liposomes to improve drug solubility, stability, and bioavailability.
Nanoemulsion Technology Protein/peptide drugs with poor water solubility are encapsulated in the oil phase to improve bioavailability.
Microemulsion Technology Protein/peptide drugs are encapsulated in a protective shell to improve the stability and bioavailability of injectable suspensions.
Polymer Nanoparticle Technology Protein/peptide drugs are encapsulated in polymer mechanisms to enhance drug stability and deliver therapeutic agents to specific target sites in the body.
Micronization Technology Protein/peptide solutions are converted into injectable powders/particles under suitable conditions by freeze-drying or spray-freeze drying technology.

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

  • We are always at the forefront of protein/peptide injectable delivery system development and drug analysis.
  • We have a team of highly skilled scientists and researchers with extensive experience and expertise in developing various protein/peptide injectable drug delivery systems.
  • Our laboratories are equipped with cutting-edge technology and equipment, and we continuously strive to improve our internal processes using the most advanced technologies and methods.
  • We provide comprehensive analytical testing services to support the development of a variety of protein/peptide injectable dosage forms, including but not limited to injectable solutions, injectable suspension emulsions, injectable nanoparticles, etc.
  • 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

Published Data

Technology: Nanoparticles Technology

Journal: Int J Nanomedicine

IF: 7.033

Published: 2013

Results:

The authors synthesized polyethylene glycol (PEG) and polylactic acid (PLA) based copolymer nanoparticles and investigated their role as vehicles for prolonged insulin delivery via parenteral route. Insulin loading was achieved using double emulsion solvent evaporation technique. The synthesized copolymers and nanoparticles were analyzed by standard polymer characterization techniques such as gel permeation chromatography, dynamic light scattering, nuclear magnetic resonance, and transmission electron microscopy and in vitro insulin release studies were performed under simulated conditions. The effect of parenteral delivery was evaluated by subcutaneous injection of nanoparticles with different insulin loads into a diabetic rabbit model. The results showed that a single subcutaneous injection of PLA-PEG 4000 nanoparticles containing 50 IU insulin load/kg body weight was effective in maintaining blood glucose levels above the physiological normal range of 90-140 mg/dL for more than 7 days. This suggests that polyethylene glycol (PEG) and polylactic acid (PLA) based copolymer nanoparticles have the potential for parenteral delivery of insulin.

Fig. 3 Molecular mass distribution of PLA-PEG copolymer. Fig. 3 Molecular mass distribution of PLA-PEG copolymer determined by gel permeation chromatography. (Tomar L, et al., 2013)

CD Formulation is always at the forefront of protein/peptide injectablel delivery system development, mastering the most cutting-edge technologies and methods. Please don't hesitate to contact us if you are interested in our services.

References

  1. Patel A, Cholkar K, Mitra AK. Recent developments in protein and peptide parenteral delivery approaches. Ther Deliv. 2014, 5(3):337-65.
  2. Tomar L, Tyagi C, Kumar M, et al. In vivo evaluation of a conjugated poly(lactide-ethylene glycol) nanoparticle depot formulation for prolonged insulin delivery in the diabetic rabbit model. Int J Nanomedicine. 2013, 8:505-20.
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