Basic Pharma - your trusted partner in nasal spray development & manufacturingend-to-end CDMO services for nasal drug delivery systems

From OTC decongestants to prescription corticosteroids and combination therapies, Basic Pharma provides end-to-end support, including:

• Formulation development (solutions, suspensions, emulsions)
• Analytical method development & validation
• Process scale-up & GMP manufacturing
• In vitro bioequivalence (IVBE) studies (preservative-free and preserved formulations)

✔ Xylometazoline – A widely used topical decongestant for relief of nasal congestion.

✔ Fluticasone Propionate – A corticosteroid used in the treatment of allergic rhinitis and other nasal inflammatory conditions.

✔ Fluticasone + Azelastine – A combination therapy used for seasonal allergic rhinitis, offering anti-inflammatory and antihistamine properties in one formulation.

Our development rigorously evaluates:

• Qualitative and quantitative composition
• Actuation volume
• Single actuation content or mass of single dose
• Droplet size distribution (DSD)
• Mass of droplets smaller than 10 µm
• Minimum fill justification, extractables and leachables
• Particle size distribution and morphological form of active substance for suspensions
• Spray pattern (SP)
• Plume angle and plume geometry (PG)
• Rheological properties (e.g., thixotropy, viscosity)
• Surface tension
• pH
• Density
• Osmolality
• Buffer capacity

Our analytical development team ensures robust testing and compliance with EMA, ICH, and global guidelines, including:

• HPLC-PDA, HPLC-RI, UV/VIS for assay, impurities, and preservative testing

• Dose uniformity, microbial limits, sterility testing

• In-use & shelf-life stability studies (ICH-compliant, climate chamber testing for Zones II-IVb)

We also perform comprehensive in-use stability studies, shelf life stability studies, and forced degradation experiments to support ICH-compliant stability programs. Climate chambers for Zones II, III, IVa and IVb.

We offer a full suite of end-to-end CDMO capabilities for nasal spray drug products, including:

• Formulation development – Expertise in nasal solutions, suspensions, and emulsion-based delivery systems. Our team develops and optimizes formulations with a focus on in vitro bioequivalence (IVBE) study requirements, physical and chemical stability, and regulatory compliance in line with current European and overseas guidelines.
• Analytical method development – A dedicated analytical development team supports method validation and stability studies, ensuring compliance with EMA, and ICH guidelines. We provide in vitro bioavailability testing, nasal spray droplet size distribution, spray pattern analysis, and plume geometry testing.
• Nitrosamine risk assessment – Our development process includes thorough nitrosamine risk mitigation, aligned with the latest regulatory expectations, ensuring your product meets the strictest global safety standards.
• Scale-up & GMP manufacturing – From pilot batches to full commercial scale, we offer GMP-compliant manufacturing with nasal spray filling and packaging lines optimized for sterile and non-sterile products. We also provide technical transfer support and market launch readiness.
• Regulatory & market expansion support – Our regulatory affairs team provides expert guidance in dossier compilation, variation filing, and CTD Module 3 preparation, supporting your product’s approval across multiple territories.