Nasal spray formulations are preferred route because of its non invasive, convenient, reliable and safe route to achieve maximum level of drugs absorption. Nasal spray formulations can be designed for unit dosing or can discharge up to several hundred sprays of formulation containing the drug substance. At APSL, we offer the services from preformulation studies, formulation development and clinical manufacturing and supply of high quality nasal spray dosage form.
APSL also provides services from product development to GMP supplies of solutions in blow fill seal technology which can be used for Nebulization.
Nasal formulations can be formulated into aqueous and non aqueous solutions depending on the API solubility and stability studies. Nasal spray formulations have certain challenges like rapid elimination of drug, minimal spray volume, compatibility with the device. All these challenges are looked after by our technical team through various formulation strategies to provide a effective drug device combination.
Stress studies, Order of addition studies, pH, osmolality and viscosity optimization studies, Preservative/ anti-oxidant effectiveness studies, Oxygen sensitivity studies, Selection of sterilization process (Filtration), Water loss studies, Bulk Hold time studies, Product part compatibility studies, Photo-sensitivity studies, Thermal sensitivity studies, Pump delivery & Spray content uniformity studies, Spray pattern/plume geometry analysis, Globule size distribution studies, Freeze thaw and Thermal cycling studies, Photo-stability studies, In-use stability studies etc.
Services across the product lifecycle
USFDA inspected lab and manufacturing facilities
Experience in delivering drug device combinations of Nasal formulations
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