Development &
Licensee Services

Support from inception through
commercialization

Aquestive is a proven and trusted provider of development and manufacturing services to industry partners. We offer customized solutions to meet a wide range of development needs and processes, from product formulation through commercialization. We design development plans by merging innovation with a thoughtful, risk-controlled approach to product development and regulatory reviews. We take a full-lifecycle view of a product and use our in-house knowledge and capabilities to tailor processes from project inception to completion — working with partners along the way to maximize the value proposition of an asset.

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Formulation Development

Our highly skilled and experienced formulation team, with wide-ranging in vitro and ex vivo screening capabilities, guides prototype selection to optimize desired product performance attributes.

Overcoming solubility and permeability challenges

Highlights

  • Systematic approach applied to address permeationbarriers
  • Robust formulation design capabilities utilize quality-by-design principles to control risk and optimize performance

The Aquestive advantage

  • Expertise in enhancement of transmucosal permeation
  • Wide range of polymeric platforms tailored to control release rate, absorption, and drug loading
  • Scalable technology to ensure consistent performance from the laboratory to commercialization

Analytical

Analytical R&D informs all aspects of product quality and performance throughout a product’s lifecycle. Analytical methods inform the formulation development process, guiding product attribute decisions and de-risking prototype selection for clinical studies. Methods are designed and validated to be robust, discriminating, and transferable for use in quality-controlled laboratories.

Highlights

  • Systematic approach utilized to characterize complex formulations and evaluate critical quality attributes
  • Specialized techniques employed to adapt to our specialized dosage forms
  • Constant focus on maintaining highly efficient and discriminating methodologies

The Aquestive advantage

  • Innovative and predictive methods unique to oral-film technology
  • Risk mitigation utilized for continuous improvement throughout the method lifecycle
  • Collaborative, cross-functional approach to validation and transfer of analytical methods
A technology transfer engineer working inside a pharmaceutical process development facility

Tech Transfer

Our tech transfer engineers harness product development knowledge to implement approaches and processes for risk-management. The use of scalable equipment throughout product development allows for the identification of scale-dependent and scale-independent variables that are verified through designed experiments prior to registrational batch manufacture.

Highlights

  • Multiple scales of analogous equipment
  • Broad experience in multiple thin-film manufacturing techniques
  • Process analytical technology (PAT) to continually drive innovation

The Aquestive advantage

  • Expertise in film manufacturing and a full-lifecycle view of a product
  • History of scale-up and validation of multiple PharmFilm® technology platforms
  • Design of experiment (DOE) methodology and subsequent stability studies utilized to identify process impacts on quality attributes
Inside a pharmaceutical research laboratory, a woman looks into a microscope

Pre-clinical

Our preclinical function interfaces with well-respected clinical research organizations (CROs) to predict product performance throughout the development process.

Highlights

  • Multiple species are utilized to ensure optimal product performance
  • Dedicated preclinical manager drives efficient and effective study design and execution
  • Highly experienced staff that is well-versed in administration of transmucosal technologies

The Aquestive advantage

  • Dedicated colonies are maintained for efficient scheduling and execution of studies
  • Full toxicology capabilities
  • Local irritation assessments performed with every study

Clinical

Aquestive’s clinical team oversees the design and execution of studies to assess the performance of development candidates and marketed products. Our clinical operations team collaborates with study management organizations and investigational sites to assure efficient, high-quality execution of clinical programs, reliable data collection and analysis, and accurate documentation of product and usability data.

Highlights

  • Experience in designing and executing studies in the United States and Canada
  • Completed and filed over 30 studies, including first-in-human studies; pivotal comparative equivalence studies; and phase 1, 2, and 3 studies
  • Experience in conducting studies in healthy volunteers and patients in confined and outpatient settings
  • Experience in conducting single-site and multi-site studies

The Aquestive advantage

  • Dedicated clinical team ensures appropriateness of study design and administration of unique dosage form and innovative technology
  • Agile and efficient team to speed development timelines
A single vertical strip of PharmFilm®

Regulatory

Aquestive’s Regulatory team is well-versed in the unique regulatory challenges and opportunities presented by drug development with PharmFilm® technology. The team works seamlessly to set the standard for quality, safety, efficacy, development, and manufacture of products for our patients and community.

Highlights

  • Experienced with the FDA approval process
  • Leadership provided during engagements with health authorities throughout the development and approval process

The Aquestive advantage

  • Sound regulatory guidance provided
  • Development of regulatory documents necessary to expedite submission timelines

Commercial

Aquestive has built a commercial team to support strong market access, sales, and uptake of novel and improved central nervous system (CNS) products. Experienced professionals bring knowledge and relationships from prior work on pharmaceutical product launches and expanded indications. For partners with commercial-ready or late-stage CNS assets, we offer the ability to expand key opinion leader (KOL) relationships, speaker bureaus, and interactions with specialists in neurology practices to support successful commercialization.

Highlights

  • A full commercial function of 50+ professionals, including marketing, marketing analytics, national field sales force, inside sales, and managed markets account managers
  • Active engagements at medical meetings and research conferences and with neurology practices, caregiver events, and activities
  • Depth of market access offerings among top commercial and Medicare payers and state Medicaid plans
  • Prior authorization and copay program support, medical information teams, pharmacovigilance, compliance

The Aquestive advantage

  • A sales structure that encourages entrepreneurial management of territory sales management and engagement with physicians, caregivers, and patients
  • Active participation in caregiver events and medical/professional meetings
  • Active collection and analysis of data from primary and secondary sources, and competitive intelligence to drive decision making around competitive entrants, distribution, manufacturing, product supply, and forecasting
Two strips of PharmFilm® aligned vertically

Take your API further

Please complete this form:

  • To subscribe to receive information updates about products and services from Aquestive Therapeutics, or to receive information about Aquestive-sponsored clinical trials, please check the box below. Please also review our privacy policy, which describes how we use and process your data. You may also contact us at any time by emailing info@aquestive.com or by calling 1-908-941-1900.

Please complete the form below and click SEND to receive a copy of “Overcoming Solubility and Permeability Challenges,” a case study detailing the achievements made by Aquestive’s formulation team to create the diazepam buccal film.

  • To subscribe to receive marketing updates about diazepam buccal film and other products and services from Aquestive, please complete the form below. Please also review our privacy policy, which describes how we use and process your data. You may also contact us at any time by emailing busdev@aquestive.com.

Please complete the form to receive a demonstration kit for our PharmFilm® technology.

  • To subscribe to receive marketing updates about our PharmFilm® technology and other products and services from Aquestive, please complete the form below. Please also review our privacy policy, which describes how we use and process your data. You may also contact us at any time by emailing busdev@aquestive.com.

Please complete this form:

  • To subscribe to receive marketing updates about products and services from Aquestive Therapeutics, or to receive information about Aquestive-sponsored clinical trials, please check the box below. Please also review our privacy policy, which describes how we use and process your data. If for any reason you no longer wish to receive information on Aquestive-sponsored clinical trials, you can contact us at any time by emailing clinicaltrials@aquestive.com.

Whether we are partnering to out license our PharmFilm® technology or in-licensing adjacent assets, Aquestive works hand-in-hand with our partners to address their toughest clinical and business challenges. To learn more, please complete the following form:

  • To subscribe to receive information updates about products and services from Aquestive Therapeutics, or to receive information about Aquestive-sponsored clinical trials, please check the box below. Please also review our privacy policy, which describes how we use and process your data. You may also contact us at any time by emailing busdev@aquestive.com.

Please complete the form below and click submit to receive a copy of “The Art of LGS Book.”