Smelling is said to be the most underrated sense. But a congested nose quickly reminds us why it is important. Besides the loss of the olfactory function, nasal blockage leads to a dangerous buildup of pathogens in the airways. Nasal spray formulation is the science of mixing drugs and excipients to free your nasal passage. A few spritzes of the right recipe will bring back the scents of life.
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Reduce the size of API particles before formulating the nasal spray
Nasal sprays are an effective drug delivery system because the nasal mucosa offers a high permeability. The gastrointestinal route has a low pH environment, so the neutral pH levels of the nasal route cause less dilution.
On the other hand, one shortcoming of the nasal cavity is the relatively limited membrane transport, posing a barrier to drug absorption. To facilitate absorption, mill the ingredients into fine particles with larger surface areas before formulating the drug.
Adjust pH level to between 4.5 and 6.5
With a pH level of around 6.5, the nasal passage is prone to irritation from substances with an acidic level. At the same time, the formula is less permeable if the active pharmaceutical ingredients have lower acidic strength than the nasal pH.
A final pH within the range of 4.5 and 6.5 typically facilitates the permeability of drugs while preventing consumer discomfort. Add pH buffers to control the levels in your nasal spray formulation.
Use gamma radiation to make preservative-free nasal sprays
Multi-dose nasal sprays may develop microbial growth, risking transferring the pathogen to the user. Traditionally, preparations include preservatives like parabens to prevent bacterial attacks. But the long-term use of these chemicals poses risks to the nasal mucosa, causing irritation and other side effects.
The manufacturing process of nasal products must ensure terminal sterilization. In the case of preservative-free formulation, subject the spray pumps to gamma radiation before filling to ensure decontamination.
Consider overheating risks caused by friction during mixing
Nasal spray preparations are formulated with various additives to enhance the drug’s effectiveness. Humectants such as glycerin avert dehydration once the substance is sprayed. Meanwhile, glycols and other medium-chain glycerides maintain the solubility of the formula. Add surfactants or fatty acid salts to boost the penetration of the final product.
Heat is a crucial consideration during formulation, mainly when using thermolabile API. The mechanism of the mixing technology itself may generate friction and raise temperatures that could degrade the formula.