Formulation Development

Creative Biolabs has significant experience in the development of pharmaceutical formulations for various dosage forms (e.g. oral, topical, injectable, powder, etc.). We perform statistically designed experiment to understand formulation parameters that impact the safety, efficiency, manufacturability, and stability in primary packaging. We ensure any forms we develop are scalable, compliant and able to be commercialized by our customers.

Our formulation development services cover a wide development spectrum. Our services include pre-formulation studies to late stage formulation development, to dosage manufacturing and packaging. In the beginning, we conduct several pre-formulation studies to understand the bulk drug's physical and chemical properties. Following, we design and optimize a salt, polymorphism, and excipients selection program to permit the development of dosage forms with good bioavailability, stability, and manufacturability. The final formulation development is aimed at optimizing the pharmacokinetic properties of drugs with good ADME. We will give your advice on packaging and storage conditions based on thorough stability studies.

Formulation Development

Creative Biolabs brings the state-of-the-art technology and highly experienced formulation specialists to help you develop the optimal dosage form for your API. We manufacture the following dosage forms:

  • Solid dosage forms (immediate and controlled release): Capsules, Bottles, and Tablets
  • Oral controlled release: Matrix based release, Multi-particulate systems, Polymer film coatings, pH-dependent release
  • Semi-solid dosage forms: Creams, Ointments, Colloids, and Gels
  • Inhaled dosage forms: Sterile and non-sterile dry powders
  • Sterile and non-sterile liquid dosage forms: Suspensions, Lotions, and Solutions
  • Injectable drugs: Intravenous, Intramuscular, Subcutaneous injectables

Creative Biolabs can provide you formulation development options with our advanced formulation development systems for APIs. We are able to overcome a variety of permeability and solubility issues. Our capabilities include:

Early stage formulation development:

  • Particle size reduction
  • Sub-micron and nano-emulsions
  • Micro-suspensions and nano-suspensions
  • Hot melt extrusion
  • Liquid fill into hard gelatin capsules
  • Dry blending and encapsulation
  • Melt granulation and encapsulation/tableting
  • Spray-drying
  • Direct compression
  • Sachets

Late stage formulation development:

  • Optimization of existing formulations
  • Manufacturing process optimization
  • Novel delivery systems for existing dosage forms
  • Controlled release and sustained release
  • Scale-up of batches and technology transfer

Creative Biolabs has also developed several novel nasal and pulmonary drug delivery forms for treating diseases, include liposomes, proliposomes, microspheres, bioadhesive nasal gels, prodrugs, cyclodextrins, etc., which provide promising alternatives for parenteral drug delivery. We also develop a nanoparticle delivery platform which composes biodegradable polymers. Several advantages are showed in this program, like the ability to be transferred into an aerosol, biocompatibility, against forces generated, and degradation within an acceptable period.

Creative Biolabs provides other various drug discovery services. For more detailed information, please feel free to contact us or directly sent us an inquiry.

Reference

  1. Tiwari G, Tiwari R, Sriwastawa B, et al. (2012) “Drug delivery systems: An updated review.” J Pharm Investig 2(1):2-11.


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USA
45-1 Ramsey Road, Shirley, NY 11967, USA
Tel: 1-631-381-2994
Fax: 1-631-207-8356
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