Our accreditations
- Monday - Friday
8.00- 18.30
- Saturday
9.30 - 17.30
- Sunday
9.30 - 15.30
- 24/7 Service available
ABOUT US
Your trusted partners
Backed by a legacy of excellence and expertise, Rubicon Research is your dedicated partner in crafting nasal and inhalation formulation development. We commit to transform your ideas into reality by using cutting-edge technologies and capabilities. From nasal pre-formulation activity to commercial supply, we bring innovative solutions to real-world challenges.
HOURS & PRICING
We look forward to seeing you!
25
years in operation
and
25+
products developed
Why Rubicon
Precision and Innovation infused advanced nasal and inhalation CDMO Services
- Health Canada license holder for Research and Development of controlled substances and cannabis-based products.
- GMP pilot plant for supporting clinical trial supplies
- The Quality Management System is designed to meet the requirements of 21 CFR Part 210 & 211(US) and Eudralex Volume 4, GMP guidelines (EU).
- End-to-end development and manufacturing services for Unit dose, Bi-dose, and metered dose nasal sprays at our manufacturing site in India.
- Development services for Dry Powder Inhalers, Nebulizers, and Pressurized Metered dose Inhalers up to technology transfer.
- Customized nasal drug development and manufacturing services to the specific needs of our clients.
OUR CAPABILITIES
Research & Development Capabilities
Laboratories built to cGMP standards with requisite building and environmental controls.
Small-scale manufacturing for clinical trial supplies and low-volume supplies for pMDI and other nasal products.
Provide full assistance for 21CFR 820.30 documentation to ensure design controls.
- Metered dose nasal spray
- Unit dose nasal spray
- Bi-dose nasal spray
- Dry powder inhalers
- Nebules/ respules
NASAL DEVELOPMENT
Development of Nasal Products
Regulatory Expertise
DEVELOPMENT CAPABILITIES
Technical expertise and the following infrastructure are available to formulate & test DPI products.
- High shear mixer – Diosna*
- Low shear mixer – Turbula blender*
- Capsule filling can be done manually*
- Anderson cascade impactor – for APSD testing of DPIs
- DUSA tube – for SAC /DDU testing
*Activities can be done in the CTM area
Alternatively, clients can also provide specific tools/ jigs for device assembly activities (which can be done in the CTM area).
The following infrastructure is available to manufacture R&D batches & test pMDI products.
- Propellant filling & crimping machine – Pamasol 2005/20
- Vacuum crimper Pamasol X2002 – 043
- Propellant pumps
- Anderson cascade impactor – for APSD testing of pMDIs
- DUSA tube – for SAC/ DDU testing
- Proveris SprayVIEW
GMP - CLINICAL TRIAL SUPPLIES
(TO SUPPORT PHASE 1 AND PHASE 2 STUDIES)
Rubicon Canada supports GMP manufacturing of nasal products for Phase 1 and Phase 2 clinical studies. The GMP area is qualified and houses qualified equipment. The movement of personnel and materials is highly regulated by QA procedures. Laboratory controls and manufacturing controls are closely monitored. Rubicon also supports packaging, labeling, and distribution. Rubicon’s documentation and record-keeping processes are well covered by QA SOPs.
Testing Capabilities
Performance Analysis
Single actuation content
Spray pattern
Plume geometry
Droplet size distribution
Drug in small droplets
Priming and repriming
IN-VITRO BIOEQUIVALENCE STUDY
Specialized in performing in-vitro bioequivalence (IVBE), characterization using accurate methodologies. For those interested in online gaming, exploring options like casino utan svensk licens trustly can provide access to various platforms with secure payment methods.
Protocol preparation and approval
Blinding And Randomization (Test Specific)
Testing Of Blinded Samples
Statistical Analysis Of Data
IVBE report compilation
Secure storage of blinded and randomized samples
Sample issuance for IVBE studies (controlled by QA)
Testing of blinded samples
Post actuation evaluation/processing
EXTRACTABLE & LEACHABLE STUDIES
Studies are conducted with region-specific guidance for both organic and inorganic contaminants according to US
Pharmacopeia and FDA recommendations, through the application of a range of high-end analytical instrumentation.
STABILITY STUDY
As per ICH Q1A guidelines varying stability chambers are available to ensure drug product stability throughout the development process.
- Long term stability
- Intermediate stability
- Accelerated stability
- Refrigerated stability
- Temperature cycling studies
- Photostability studies
CHEMICAL ANALYSIS
Wide range of analytical techniques for analytical development and characterization of finished dosage form:
Chromatography
(HPLC,GC, IC, etc.)
Potentiometry
Spectroscopy
Manufacturing Capabilities
Rubicon Research’s facility in India is equipped with fully automated filling lines for the manufacturing and filling of nasal spray solutions and suspensions. An aseptic environment and terminal sterilization ensure the product’s safety and integrity. Our versatile packaging options accommodate diverse packaging needs.
- Batch sizes from 5–10 L for unit dose/bi-dose nasal spray products and
50-500 Litres for metered dose nasal sprays - Class A filling facility with sterile grade controls
- Capable of handling unit and bi-dose nasal spray formats
- Change parts compatible with Aptar devices
- Automated vial filling and device assembly
- Micro vials autoclaving process before device assembly
- Secondary packaging ability for Blister packing Cartoning
- Tolerance of +/- 0.1%
- High speed fully automatic machine with an output of 100 units/minute in a fully assembled format
- Annual capacity of 10mn units on a single shift basis (UDS)
- Capability to fill and assemble unit/bi-dose spray devices
- Automatic loading of glass micro vials, positioning, and insertion of plungers
- Automatic unloading of micro vials through a double pneumatic pick and place system
- Fully automatic device assembly on both clinical and commercial scale fillers
- Blister packaging capability available
- Automatic infeed of nasal spray device
- Liquid filling line disc with a dosing range of 20 -100 ml with nitrogen flushing and laminar airflow
- Spray pump stations and automatic positioning and closing of the spray pump
- In-process check weigher (automatic rejector)
- Machine with filling output capacity of up to 180 bottles/ minute
- Annual capacity of 12mn units on a single shift basis
- Capability to fill and seal unit dose in snap cap, crimp, and continuous thread closures
ANALYTICAL METHOD VALIDATION/ VERIFICATION & TRANSFER
We provide complete support for analytical method validation and verification for drug substances and drug products as per ICH Q2(R1) guidelines.