Experience Makes the Difference.

NASAL

With a state-of-the-art laboratory, cutting edge spray characterization instruments, almost 20 years in nasal experience and successful commercialization of products for the US and European markets, Renaissance is the “one-stop shop” for all your nasal spray formulation, development, testing, and commercialization needs. Our expert technical staff are continually contributing to the pharma industry’s understanding of nasal spray behavior through publications and presentations. Our capabilities cover both development and commercial scale manufacture of unit dose, bi-dose and multi-dose nasal sprays in environmentally controlled production facilities. With an excellent history of regulatory approvals, we are able to onboard projects at any stage of their life-cycle – from initial concept, through formulation development/optimization and clinical manufacture, to the transfer of existing commercial products.

CAPABILITIES

  • Metered unit dose, bi-dose, multi-dose (snap-on, screw-on, and crimp-on pumps), and sublingual devices

  • DEA controlled substances Schedule I-V

  • Stability storage and testing (ICH and customer specific)

  • Sterile filling

    • ISO 5/ Class 100/ Grade A Filling

    • ISO 7/ Class 100,000/ Grade C Filling

NASAL SPRAY
CHARACTERIZATION SERVICES

  • Effect of dosing orientation

  • End of unit life determination

  • Priming and re-priming

  • Cascade impaction

  • Particulate matter USP<788> Methods 1 and 2

  • Single-actuation content / delivered dose uniformity

  • Plume geometry

  • Spray pattern

  • Droplet size distribution

  • Pump delivery

  • Method development, validation, and release testing

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SUPPORT SERVICES

  • Formulation development and optimization

  • Analytical and microbiological method development, validation and release testing

  • Anti-microbial effectiveness / microbial limits testing (bioburden) / endotoxin testing

  • Bioequivalence testing

  • Particulate investigation

  • Particle size distribution

  • Emulsion droplet size determination

  • Regulatory services and project management capabilities.

  • Device selection

  • Device reliability

  • Device functionality testing

RESEARCH & DEVELOPMENT SERVICES

  • Pre-formulation & Formulation development

  • Analytical development and validation

  • Spray Characterization method development and validation

  • Process development and validation

  • Clinical Trial Material Manufacturing

  • Stability studies: ICH and custom

  • QbD Services

    • Formulation

    • Process Development

    • Scale-up

PACKAGING SERVICES

  • Identification and Sourcing Services

  • Specification Development

  • Dose Volume Evaluation

  • Drug/Package Compatibility

  • Commercial Scale Fill and Finish Assessment

  • Equipment Sourcing, Design, Engineering, Qualification, and Validation

  • Serialization