Sprays Formulation Development

When developing sprays, formulation and device development go hand in hand. Changing one affects the other, and vice versa. For example, the design and geometry of the nozzle can affect the stresses placed on the suspension and thus the distribution of the spray droplets. Similarly, changes in excipients may affect the viscosity of the formulation as well as the efficiency of nozzle pumping - which is critical because drop size distribution affects where the drug is deposited in the respiratory tract and therefore its biologic efficiency and speed of onset of action. CD Formulation provides clients with expert development of spray formulations that we help our customers to rapidly develop their products and accelerate their commercialization.

Background

Sprays formulations are preparations in which the raw drug or suitable excipients are filled in a specially designed device and the contents are released in a mist for pulmonary inhalation or sprayed directly onto the mucous membranes of the cavity and skin by means of pressure from a manual pump, high-pressure gas, ultrasonic vibration or other methods. According to the route of administration, it can be divided into inhalation spray, nasal spray and non-inhalation spray for skin and mucous membrane.

Our Services

CD Formulation provides the following specialized sprays development for our clients.

• Inhalation Sprays Formulation Development
• Nasal Sprays Formulation Development
• Non-inhalation Sprays Formulation Development

Process Development

Our physicochemical characterization tools are used to assess the stability of APIs and excipients in formulations throughout processing conditions to ensure that process parameters are controlled and optimized so that the final drug product meets the required critical quality attributes. Our solutions can also be used to help with comparability assessments to check for product changes as manufacturing processes change.

Spray Check

• Primary drug content per spray

Check method: Take 1 bottle of the test product, test spray 5 times, wash the spray nozzle with solvent, dry it sufficiently, spray 10 or 20 times, collect in a certain amount of absorbent solvent, transfer to a suitable volume bottle and dilute to the scale, shake well, and measure.

• Fine particle dose

Inhalation sprays for nebulizer should be checked for microparticle dose, according to the method of determining the aerodynamic properties of inhalation preparations of microparticles, according to the methods specified under various items, determined according to law, calculate the dose of microparticles, should comply with the provisions.

• Delivery rate and total delivery

Inhalation sprays for nebulizer should check the rate of delivery of active substances and the total amount of delivery.

• Sterility

Inhalation sprays for nebulizer, quantitative inhalation sprays and sprays for burns, severe trauma or clinical necessity of sterility, according to the sterility inspection method.

• Microbial limit

Checked according to the microbial limit inspection method.

If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.