Hovione

About Hovione

Hovione has over 60 years of experience as a CDMO and is a specialized integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA inspected sites in the USA, China, Ireland and Portugal and development laboratories in Portugal and USA, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds. 
Hovione offers a full range of development services and manufacturing capacity in particle engineering (Spray Drying, Spray Congealing, Hot Melt Extrusion, Jet Milling, Nanoparticles and Wet Polishing) to provide optimal solutions for your drug product with the right scale and flexibility. 

For generic pharmaceutical customers the company offers niche API products. Hovione also provides proprietary product development and licensing opportunities for drug products. 

In the inhalation area, Hovione is the only independent company offering a complete range of services.  

Visit www.hovione.com

Certifications
Categories
  • PT
  • 2015
    On CPhI since
  • 2
    Certificates
Manufacturer/Innovator
Contact info

Products from Hovione

  • The Specialist Integrated CDMO

    Product The Specialist Integrated CDMO

    Hovione helps you bring new medicines to patients in an unprecedented speed.

    As a fully integrated CDMO, we offer over 60 years’ experience in chemical process development and manufacture of APIs. Our more recent capabilities in Drug Product together with our innovative science, the most up-to-date technologies and multidisciplinary teams - all at the same physical location – deliver the most impeccable end-to-end solutions to help your project succeed.

    Drug Substance • Process development & optimization, clinical & commercial supply 
    • Cryogenic reactions 
    • Hydrogenation 
    • Customized off Patent APIs
    • Highly potent APIs, cat. 3a and 3b 
    • API+ (Drug Product Intermediate) 
    • Analytical method development & validation 
    • Proven track record in Quality by Design

    Particle Engineering 
    • Solubility enhancement 
    • Amorphous Solid Dispersions 
    • Inhalation 
    • Controlled release 
    • Development by Design™

    Drug Product 
    • High containment 
    • High precision capsule filling 
    • Tableting / Film coating / Dry granulation 
    • Oral and Inhaled dosage forms
    • Continuous Tableting using wet granulation, dry granulation or direct compression 
  • Spray Drying

    Product Spray Drying

    Hovione is the leader in Spray Drying, thanks to the largest capacity, the best scale-up science and the most experienced team.

    Spray drying is a continuous process that can be used for multiple applications. Over the last 15 years, the technology has been used for the production of solid dispersions and is the fastest growing platform to overcome the solubility issues related to oral drugs, it is also relevant to inhalable particles, specialty excipients and for the isolation of thermally labile products.

    How it works
    The feed (a solution, emulsion or suspension) is atomized into hot nitrogen leading to flash (rapid) drying and particle formation. The particles are then separated in a cyclone and/or filter bag.

    Applications
    Solid dispersions
    Amorphous materials (drug + polymer) used to overcome solubility limitations of BCS class 2 and 4 drugs. Both drug and polymer need to dissolve in the solvent system.

    Microencapsulated particles
    Crystalline drug encapsulated with a coating polymer. For example, enteric polymers can be used to protect the drug from the gastric conditions or for enhanced delivery to the site of maximum absorption. Similar approaches can be used for taste masking and for protecting the drug from physical environments (e.g. light, moisture).

    Inhaled powders
    Ability to control particle size, morphology and other properties with direct effect in Fine Particle Fraction (FPF) and lung deposition.
    Spray drying is also the method of choice for materials that cannot withstand abrasion or shearing, like biologics. Hence, it is the preferred option for new the generation of inhaled formulations for biologics.

    Isolation of thermally labile materials
    Due to the gentle nature of the process it can be used to isolate materials that degrade during conventional isolation processes.


  • Everything for Inhalation

    Product Everything for Inhalation

    At Hovione we can tailor-make particle size distributions through complex particle engineering technologies, like wet-polishing and monosep, in ranges suitable for inhalation and incorporate desired morphology characteristics into your API. We are also able to start with a Hovione-produced API and develop a dry powder formulation to meet your inhalation product development demands.

    The cutting edge particle engineering technologies suitable for inhalation coupled with hands-on inhaler development knowledge allows Hovione to deliver high quality results for partners' inhalation drug development programs, ranging from developing new products for inhalation to matching innovator in-vitro deposition profiles.

    Inhalation Drug Development Services

    Based on our more than 20 years experience in inhalation, Hovione presents business partners with an unique opportunity to speed up their inhalation drug development, from a very early stage to a late development stage. Working with Hovione allows partners to take advantage of cutting edge particle engineering technologies and state of the art analytical facilities operated by highly skilled and responsive staff.

    Key Technical Capabilities
    • Particle size reduction
    • Particle engineering technologies – (jet milling, wet polishing, microencapsulation, monosep, nanomilling and others)
    • Cascade impaction (Fast Screening Impactor, Andersen Cascade Impactor and Next Generation Impactor)
    • Stability studies of inhalation powders
    • Inhalation powders formulation
    • Surface analysis (API and excipient)
    • Non-carrier based formulation
    • Carrier-based formulation
    • Excipient identification, sourcing and characterization
    • Microbiology controls
    • Expert inhaler development services
    • Seamless integration between formulation and inhaler development
    • Proven track record in developing market approved drug products for inhalation
    In addition to inhalation formulation services and devices we also offer:
    • Automated capsule filling, for supporting both clinical and commercial purposes
    • Packaging and finishing, for supporting clinical purposes
  • API PORTFOLIO

    Product API PORTFOLIO

    Hovione's APIs offer impeccable chemical purity and unique product performance.


  • OFF-PATENT APIs

    Product OFF-PATENT APIs

    High value applications Hovione provides off-patent APIs that can be used with confidence where the choice of active ingredient is critical.
    • Branded generics where quality and security of supply is paramount
    • Difficult to make AB rated generics such as nasal and inhalation products where developing a product that consistently matches the innovator performance is very challenging
    • 505b2 applications or new combinations of off-patent API where industry leading technical and regulatory support are needed to guarantee the timelines and success of your projects
  • Hot Melt Extrusion

    Product Hot Melt Extrusion

    Hot melt extrusion is a fast growing technology platform that is utilized to solve difficult formulation challenges, primarily in the area of solubilization.
    n recent years Hot Melt Extrusion (HME) has been used extensively in solubility enhancement applications for polymer-based amorphous solid dispersions (provided the Drug Substance is thermally stable). In this respect, the technology competes directly with spray drying and may offer advantages in terms of cost and throughput.

    How it works
    Powders (drug substance, polymer and other excipients, if necessary) are fed into heated processing zones within the extruder. Modular twin co-rotating screws impart a high degree of shear and mixing into the molten mixture, creating a homogenous mass. After exiting the extruder, the molten extrudate is rapidly cooled and solidified. In most cases the solid extrudate is further processed into a powder and incorporated into a solid dosage form.

    Applications


    Solid dispersions
    Amorphous solid solutions (drug molecularly dispersed in amorphous polymer system) are used to overcome solubility limitation of BCS class 2 and 4 drugs. In these applications, the polymer is capable of kinetically stabilizing the API in the solid state and after exposure to a dissolving media. Similarly, crystalline solid dispersions can be prepared which exhibit improved wetting and dissolution characteristics.

    Controlled release
    Controlled release extrudates can be obtained by adding water insoluble our high molecular weight water soluble polymers into the processing mixture.

    Microencapsulated particles
    Crystalline drug may be encapsulated with a polymer during processing. For example, enteric polymers can be used to protect drugs from the gastric conditions or for enhanced delivery to the site of maximum absorption. Similar approaches also can be used for the taste masking of drug substances.

  • Jet Milling

    Product Jet Milling

    Particle Engineering Technologies We specialize in particle engineering technologies to address oral bioavailability, lung delivery, modified release and taste masking. In each technology we can support you from proof of concept to commercial manufacturing.
    Jet milling
    Jet milling is a highly effective technology for reducing particle size of inhalation and other drug products where the size of the particle is relevant to the effective delivery.

    How it works
    Jet milling is the standard API particle size reduction method. The powder is fed into a milling chamber where compressed air/nitrogen, usually in a vortex motion, promotes particle-to-particle collisions. Particle classification is made by inertia, following reduction via impaction and abrasion.

    Applications
    Powders for inhalation - Leading technology to obtain powders in the inhalation size range
    Micronized powders for oral delivery - Powders that can be used to overcome solubility limitations of BCS class 2 and 4 drugs
  • Nanoparticles

    Product Nanoparticles

    Particle Engineering Technologies
    We specialize in particle engineering technologies to address oral bioavailability, lung delivery, modified release and taste masking. In each technology we can support you from proof of concept to commercial manufacturing.

    Nanoparticles
    At Hovione we have both top-down and bottom-up technologies to produce pharmaceutical nanoparticles for oral delivery.


    Nanoparticles are very useful when oral bioavailability is limited by the dissolution rate of the active pharmaceutical ingredient. The commercial utility is expressed by the multiple products approved in the market over the last decades. Hovione particle design tool box includes both “Top Down” and “Bottom up” technologies to produce nanoparticles of active ingredients.

    How it works
    In top down processes, nanoparticles are produced by wet milling processes. On the other hand, in bottom up processes crystalline or amorphous nanoparticles can be obtained by crystallization or precipitation processes, respectively. Nanoparticle isolation or microencapsulation can then be achieved by spray drying.

    Applications

    Overcome solubility limitations of BCS class 2 and 4 drugs - oral administration as capsules, tablets or suspensions
    Sustained release formulations e.g. in ocular delivery
    Injectable formulations
  • Spray Congealing

    Product Spray Congealing

    Particle Engineering Technologies
    We specialize in particle engineering technologies to address oral bioavailability, lung delivery, modified release and taste masking. In each technology we can support you from proof of concept to commercial manufacturing.

    Spray Congealing
    In recent years the technology has been used for controlled release formulation and also for taste masking. In the latter application it is particularly suitable for oral disintegrating tablets since it provides perfect encapsulation at particle level.

    How it works
    The API is dissolved (or suspended) in a melted excipient (typically a low melting point polymer) and atomized into cold nitrogen leading to solidification of the droplets and particle formation. The particles are then separated from the gas stream in a cyclone and/or a filter bag. This is a solvent-free process that makes use of spray drying assets as a means of isolating the newly formed particles.

    Applications
    Solid dispersions
    Amorphous materials (drug + polymer) used to overcome solubility limitations of BCS class 2 and 4 drugs.

    Microencapsulated particles
    Crystalline drug encapsulated with a coating polymer. For example, enteric polymers can be used to protect drug from the gastric conditions or for enhanced delivery to the site of maximum absorption. Similar approaches can be used for taste masking and for for protecting the drug from physical environments (e.g. light, moisture).

    Pharmaceutical cocrystals
    Cocrystals are multicomponent crystals of, at least, two molecules (API+coformer) combined in a stoichiometric ratio. Cocrystals have shown efficacy on improving aqueous solubility of poorly water-soluble APIs, hygroscopicity, stability, taste, and downstream processing capacity.

  • Wet Polishing

    Product Wet Polishing

    Particle Engineering Technologies
    We specialize in particle engineering technologies to address oral bioavailability, lung delivery, modified release and taste masking. In each technology we can support you from proof of concept to commercial manufacturing.
    Wet Polishing
    Hovione developed wet polishing as a solution for generating 100% stable crystalline material which is recovered utilizing a spray drying process.

    Wet polishing is a process that combines two integrated technologies: one to attain a small particle size (either a bottom-up technique such as controlled crystallization or nanocrystallization or top down technique such as high shear mixing or high pressure homogenization); and two to isolate the particles (for example spray drying or filtration followed by a drying process). This combination can be used to fine tune particle size and morphology in order to meet specific drug delivery requirements.

    Applications
    Powders for inhalation
    Powders with very tight particle size distributions

    Micronized powders for oral delivery
    Micro- and nanoparticles used to overcome solubility limitations of BCS class 2 and 4 drugs

  • Aclidinium Bromide

    Product Aclidinium Bromide

    Aclidinium Bromide for development trials with customized Particle Design, resulting in Inhalation grade material with highly customizable PSD to befit your application.
    Our technology and expertise yields unmatched impurity profiles with highly reproducibility between batches, resulting in a superior API.

    MSDS is available for customers requesting samples.

    ROUTE OF ADMINISTRATION: Inhalation
    REGULATORY STATUS: US DMF

  • Beclomethasone Dipropionate Anhydrous

    Product Beclomethasone Dipropionate Anhydrous

    ROUTE OF ADMINISTRATION: Inhalation, Nasal, Oral, Topical
    Hovione is a world leader in regulated markets offering APIs for human applications for over 60 years.
    With an unblemished regulatory track record Hovione makes available offer an unrivalled technological range to provide the API with bespoke attributes to fit your application.
    With FDA and PMDA approved sites Hovione has an uncompromising commitment to quality and is a founding member of the Rx-360 consortium.

Hovione Resources