PHARMACEUTICAL SPRAY DRYING
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PHARMACEUTICAL SPRAY DRYING Creating New Business Opportunities and Revenue Growth for Drug Makers SOLUTIONS MADE SIMPLE | LONGSTANDING TRUSTED SOURCE, CONSTANT INNOVATION

Spray drying technology has been around for more than 150 years. First used in 1872 for “powderizing” milk, spray drying continues to be widely used for production of powdered instantized milk. But it’s only been during the last 30 years that its seen rapidly increasing use in the pharmaceutical industry, especially for improving the solubility profile of poorly water-soluble Active Pharmaceutical Ingredient (API). Following are several cases where drug makers might benefit from spray drying technology. These points may help readers examine their own business strategies and drug portfolios,...

(1) SOLUBILITY ENHANCEMENT WITH AMORPHOUS SOLID DISPERSIONS Many drug substances have been proven to have good efficacy to treat illnesses. But commercial interest in these substances has been limited by poor solubility and the resultant high drug loading required for patients to receive therapeutic dose. This is largely apparent with Active Pharmaceutical Ingredient (API’s) falling into the Biopharmaceutics Classification System (BCS) II and BCS-IV categories for permeability and solubility. In simple terms, spray drying for solubility enhancement involves creation of a stable, molecular...

(2) ENCAPSULATION TECHNIQUE FOR TASTE MASKING AND FOR ENGINEERED DRUG RELEASE PROFILES Encapsulation techniques are already widely used for taste-masking, gastric protection of drug substances, creation of modified release profiles and for extended release over time. Technologies already in use for encapsulation are fluid bed processing, high shear granulation and bead coating for multi-particulates and micro-tabs. For a drug company already using these techniques, spray drying can offer another technique to their capabilities. In some cases, drug product line extensions can become...

(3) PROCESSING SUBSTANCES THAT ARE SUBJECT TO THERMAL DEGRADATION For substances that are susceptible to damage from continuous exposure to elevated temperatures, which is common in batch processes, spray drying can be an attractive processing method to consider. In a spray dryer, the atomized solution droplets are exposed to drying gas for only a very short period (just a few seconds). Heat is given up during rapid evaporation to provide a cooling effect for the dry material before it exits the drying chamber. This principle of the spray drying process helps it compete well against some...

(4) PRODUCTION OF DRUG PRODUCTS FOR DRY POWDER INHALATION (DPI) While solubility enhancement is important for certain drugs, it may still not be adequate for a suitable product to succeed as an oral dosage form. For this reason, manufacturers might create spray dried powders for pulmonary delivery achieve desired efficacy and also to permit more favorable receptor targeting. Inhalation bypasses the oral route and eliminates the variables of gastric chemistry and adsorption in the intestinal track. Dry powders for inhalation must be produced within a narrow aerodynamic particle size range of...

(5) PRODUCT LINE EXTENSIONS & NEW PRODUCT INNOVATIONS USING AN FDA 505(B)(2) REGULATORY FILING PATHWAY Spray drying is an enabling technology that can help a drug maker extend the life of their proprietary products. It allows for use of Active Pharmaceutical Ingredient (API’s) that are already thoroughly understood and even in use for existing approved drugs. All the in vitro experiments, toxicology, efficacy, and clinical studies are already complete, which greatly reduces the financial barrier to bringing new drugs to market. With regulatory barriers diminished because of all the prior...

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