Our Respiratory & Inhalation Product Expertise

Dry Powder Inhalers (DPI)

Development-oriented research into carrier-based and other dry powder formulations, focusing on API particle properties, powder flow, excipient selection, blending, moisture sensitivity, device compatibility and aerosol performance.

Pressurized Metered-Dose Inhalers (pMDI)

Formulation and product-development considerations include API suspension or solution systems, propellant and excipient selection, suspension stability, valve compatibility, delivered-dose uniformity and aerosol characteristics. Low-GWP propellant strategies may also be explored where applicable.

Nebulized Inhalation Products

Research into inhalation solutions and suspensions, considering solubility, pH, viscosity, osmolality, aerosol generation, delivered dose, residual volume, stability and nebulizer compatibility.

Nasal & Respiratory Delivery Systems

Development-oriented research into nasal sprays, solutions, suspensions and mucosal delivery systems, with attention to formulation properties, device compatibility and spray performance.

Inhalation Product Characterization

Inhalation product performance depends on consistent dose delivery and suitable aerosol characteristics. Depending on the product and available testing capabilities, evaluation may include:

Aerodynamic Particle-Size Distribution (APSD): Assessment of aerosol particle-size distribution.
Fine-Particle Dose (FPD) & Fine-Particle Fraction (FPF): Evaluation of the respirable aerosol fraction.
MMAD & GSD: Characterization of aerodynamic particle-size distribution.
Cascade Impactor Studies: ACI or NGI-based evaluation, where applicable.
Delivered-Dose Evaluation: Assessment of dose consistency and product performance throughout use.

Device–Formulation Compatibility

Successful inhalation development requires an integrated understanding of the relationship between the drug, formulation, device and patient-use factors. Our development considerations may include powder dispersion, device resistance, valve performance, actuator design, spray characteristics, airflow requirements, priming, cleaning and environmental influences. Drug Substance → Formulation → Device → Aerosol Generation → Inhalation → Pulmonary Deposition

Formulation Optimization for Pulmonary Delivery

We explore strategies to address challenges such as poor solubility, particle aggregation, moisture sensitivity, dose variability, instability, inadequate aerosolization and device incompatibility. Potential approaches include particle-size engineering, micronization, carrier-based DPI systems, spray-dried particles, solubility enhancement, lipid-based systems and advanced pulmonary delivery platforms.

Respiratory Product Development Workflow

Our science-driven development pathway may include:

API Characterization → Preformulation → Formulation Strategy → Device Assessment → Prototype Development → Aerosol Performance Evaluation → Optimization → Stability Studies → Scale-Up → Technical Documentation Each stage is planned according to the product’s technical requirements, development objectives and applicable regulatory expectations.

Product Performance & Optimization

We consider formulation and device performance together to support the development of robust, reproducible and scalable inhalation products. The scope of work is determined by project requirements, available infrastructure and the specific testing or development needs. Discuss Your Respiratory Product Development Project Connect with HSP Research Group LLP to discuss inhalation formulation challenges, device–formulation considerations and potential respiratory drug-delivery research projects.

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Development Area	Representative Parameters
Dose Delivery	Delivered dose, emitted dose, dose uniformity
Aerosol Performance	APSD, MMAD, GSD, FPD, FPF
DPI Performance	Powder flow, dispersion, deaggregation, device resistance
PMDI Performance	Spray pattern, plume geometry, valve/actuator performance
Nebulizer Performance	Delivery rate, aerosol characteristics, residual volume
Formulation	Assay, content uniformity, stability, particle characteristics
Device Compatibility	Formulation–device interaction, material compatibility
Stability	Physical, chemical and performance stability
Patient Use	Flow rate, inhalation maneuver, handling and device usability

Quality-by-Design Approach

Where appropriate, we apply Quality by Design (QbD) and Design of Experiments (DoE) principles to understand critical formulation and process variables and optimize product performance, consistency and critical quality attributes (CQAs).

Regulatory & CMC-Oriented Development

Our product-specific development approach may include pharmaceutical development studies, analytical method development, inhalation performance characterization, CMC documentation, comparative evaluation, technology transfer and regulatory-development support.

Why Respiratory & Inhalation Research Matters

Pulmonary drug delivery offers opportunities for localized respiratory treatment and systemic delivery of selected therapeutics. Our research interests include inhaled drug products, pulmonary delivery and advanced respiratory drug-delivery systems.

From Formulation to Pulmonary Performance

At HSP Research Group LLP, we consider the integrated relationship between the drug, formulation, delivery device and patient-use requirements to support the development of products that are scientifically sound, stable, consistent, device-compatible and scalable. Our development approach may span formulation strategy, characterization, optimization, scale-up and technology transfer, depending on project scope and available capabilities.

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