Spray Drying

Improving the bioavailability of poorly soluble compounds

Overcoming poor drug solubility and bioavailability challenges

Poor solubility is becoming increasingly prevalent in drug development pipelines across the pharmaceutical industry, with approximately 70% of drugs that enter development possessing insufficient aqueous solubility for adequate and consistent gastrointestinal (GI) absorption. One proven method of improving the solubility, and hence bioavailability, of drug candidates is spray drying.

At Quotient Sciences, we use a broad range of formulation approaches to address complex solubility and bioavailability challenges, ensuring technology selection is driven by molecule needs. Within our technology portfolio, spray drying is an established capability. Our experts tailor formulation strategies based on the unique physical, chemical, and biopharmaceutic properties of each drug candidate, working within state-of-the-art facilities capable of handling high-potency compounds.

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What is spray drying?

The technique of spray drying involves dissolving a drug in an aqueous or organic solvent in the presence of a polymer. The resulting solution is then rapidly dried with hot gas to form a dispersion, known as a spray-dried dispersion (SDD).

A scientist working on solubility enhancement in one of the laboratories at Quotient Sciences.

How does spray drying improve drug solubility?

Spray drying produces a homogeneous solid mixture containing the drug and solubilizing polymer. SDDs improve drug solubility by making several key changes to the properties of the drug relative to its parent crystalline form:

  • The molecule is converted to an amorphous, high-energy physical form, which, in the presence of the polymer, promotes enhanced aqueous solubility, resulting in a faster dissolution rate and up to ten times the saturated solubility of crystalline drug
  • The polymer can inhibit the precipitation of the dissolved drug, resulting in sustained solubility
  • The polymer stabilizes the drug in a glassy state, improving the long-term physical stability at a variety of temperature and humidity conditions

Quotient Sciences’ unique solution to overcoming solubility challenges

  • Identify and address critical formulation issues quickly
  • Optimize the performance of your formulation
  • Support your formulation development from pre-clinical to clinical evaluation

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How can Quotient Sciences’ spray drying capabilities help me?

Quotient Sciences has a proven track record of developing and manufacturing SDDs to overcome poor drug solubility and delivery challenges. We tailor the development of SDDs towards the specific physical, chemical, and biopharmaceutic properties of each molecule. Over the past 2 years, we have advanced more than 25 SDD formulations into clinical studies.

Using state-of-the-art equipment, including ProCepT spray dryers for batches of up to 1 kg and a Niro Mobile Minor spray dryer for batches of 1–10 kg, we develop SDDs using both aqueous and organic solvent-based processing intended for both oral and inhaled drug delivery.

Developed SDDs can be administered either as a powder-in-bottle reconstitution prior to dosing, or they can be further formulated as a powder-in-capsule or tablet presentation.

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Information sheet: Spray drying

Drug solubility has a significant impact on bioavailability, so selecting an appropriate formulation is imperative to the success of a development program. To find out more about how Quotient Sciences can help you overcome drug solubility and bioavailability challenges using spray drying, download our info sheet.

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Featured blog: Overcoming Challenges with Poorly Soluble Molecules in Early Development

With over 30 years of experience, the team at Quotient Sciences has established a broad suite of technologies and formulation strategies to address complex solubility challenges, including particle size reduction (micronization), spray-dried dispersions (SDDs), hot melt extrusion (HME), and lipid-based formulations. Using our unique Translational Pharmaceutics® platform, which integrates drug substance, drug product development, real-time adaptive manufacturing, and clinical testing, we are able to streamline the development of poorly soluble molecules. Flexible study protocols and rapid ‘make-test’ cycles enable the optimization of formulations in real time based on arising human clinical data. This reduces development risks, maximizes the probability of clinical and commercial success, and saves time and costs.

In this article, we review some recent scientific posters published by Quotient Sciences that highlight innovative strategies to overcome challenges with poorly soluble molecules in early development.

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