FORMULATION | TESTING | PROBLEM SOLVING
Pulmatix Pty Ltd is a contract testing, formulation and R&D company. With over 20 years expertise in product formulation and characterisation, our team can provide robust scientific solutions to enable your company to develop effective therapeutic, cosmetic and agricultural products. We offer specialist services for aerosol-based products.
DEVICE AND PACKAGE TESTING
We provide the pharmaceutical, cosmetic and agriculture sectors with robust product testing solutions. We can perform both standard and non-standard tests for a range of products and develop custom solutions for our clients. Many products have bespoke testing requirements and we can develop validated methodology and specialist testing rigs. Standard testing services include:
- package robustness
- orientation studies
- content uniformity & dose reproducibility
- aerosol analysis
- API dissolution
- stability & accelerated stability studies
- particle size analysis
- moisture interaction & content
- thermal stability
- foreign particle analysis
- method development & validation
We have state of the art testing facilities at our Glebe headquarters. With a comprehensive suit of facilities we can provide you with critical product information rapidly.
AEROSOL ANALYSIS
We provide analytical services specifically tailored to aerosol generating products. We can characterise the aerosol properties of sprays and aerosols produced from pump dispensers, pressurised canisters, pressurised metered dose inhalers, nebulisers and dry powder devices. We have a number of testing methodologies and can provide custom solutions. Standard testing services include:
- high speed Spraytec laser diffraction (Spraytec)
- delivered dose uniformity
- aerodynamic size distributions
- USP/EUPh testing methodology
- anderson cascade impactor (ACI) studies
- next generation impactor (NG)) studies
- multi-stage liquid impinger (MSLI) studies
- full analytical services (HPLC & HPLC-MS)
- in vitro bio-equivelence studies
- particle size statistics and respiratory fraction analysis
- MMAD, GSD, %<10 µm, FPD, FPF etc
Using our state-of-the-art aerosol testing facilities, we can provide you with the information you need for development or registration of your aerosol product.
Formulation support
Pulmatix Pty Ltd can supply full formulation support for your aerosol product. With over 20 years experience in the area of device and formulation R&D we are able to formulate aerosol delivery systems for both upper and lower respiratory tract delivery. These include, pMDIs, DPIs nebulisers, nasal sprays and next generation inhalers. We can offer:
- API and excipient customisation (i.e milling, organic spray drying and advanced particle engineering).
- DPI formulation and optimisation studies.
- Lab scale filling of suspension and solution pMDIs.
- Nebuliser and nasal formulations.
- Device engineering services and rapid prototyping
- Non-Pharmaceutical based aerosol formulations
Consultation
Pulmatix Pty Ltd can provide clients with expert consultation services. With over 20 years of problem solving in the sector, our specialists can provide you with rapid solutions to your formulation and device challenges. These include formulation and device parameter advice as well as specific problem solving consultation services including:
- Advice on device parameters and testing protocols
- General device and formulation problem solving
- Identifying formulation stability issues and solutions
- Packaging and product robustness solutions
- Identifying and resolving filling line issues
- Biosimilars and generics consultation
- Patent litigation and patent infringement
Pre-clinical
TOXCICITY | TRANSPORT | EFFECT
Pre-clinical
TOXCICITY | TRANSPORT | EFFECT
TOXICITY
EPITHELIAL CELL STUDIES
Using specific respiratory and nasal cell types, we are able to provide comprehensive API, excipient & formulation pre-clinical toxicity and cell response studies. This is essential at the early stages of product R&D to identify downstream clinical issues.
TRANSPORT
REAL SYSTEMS
We have a number of bespoke models for evaluating aerosol deposition, transport and pharmacokinetics. We utilise both cell and non-cell based models, incorporated into conventional pharmacopeia apparatuses, to assess the deposition, transport and dissolution.
EFFECT
PHARMACOLOGY
We have a number of cell culture models for studying the interaction of your API or formulation at a cellular and molecular level. These include, mucus & cilia function models, inflammatory response, metabolic processes, cell migration and bacteriological assays.
