Drug development

The starting point of our development activities is to precisely and comprehensively characterise the active pharmaceutical ingredient (or combination of multiple active ingredients) as well as the interaction with the excipients. We draw on a wealth of experience, a highly qualified team of experts and a wide range of analytical methods. Nanotechnology in particular represents a focus within these new technologies.

The quality of active pharmaceutical ingredients is identified by a series of chemical and physical characteristics, which have a critical impact on the stability and efficacy of a medicinal product. Knowing the chemical and physical nature of the active ingredient and optimising as required is vital for successfully developing a medicinal product.

Besides others, we therefore investigate the following parameters:

• Content or activity
• Chemical degradation products, light sensitivity
• Particle size distribution, particle shapes and morphology
• Polymorphism, crystallinity
• Compatibility of active ingredients and excipients
• Solubilities
• Stability and compatibility

If a certain quality of an active pharmaceutical ingredient needs to be procured, we can offer our customers the following services:

• Active pharmaceutical ingredients sourcing in accordance with current regulatory requirements (e.g. generic API in accordance with EP and USP)
• Active substance development / -further development and production (with partners)
• Patent and property right research for active substances

We develop and manufacture solid, semi-solid and liquid dosage forms for oral, topical, nasal and parenteral use in small to medium sized batches. In our clean rooms we are capable of working with high potent active ingredients (up to OEL4 / OEB 5), highly toxic substances and substances with unknown toxicity.

Interconnecting services in formulation development, analytical testing and regulatory within HWI group enables us to offer drug development as a complete package or in individual modules.

CMC development covers:

• New development of drug products and related products
• Development of innovative products for poorly soluble active ingredients or new applications
• Optimisation and re-formulation of existing products
• Generic developments
• Development of herbal medicinal products
• Development analytics
• Manufacture, packaging, release testing and release as well as distribution of clinical trial medication and small up to mid-size batches

Dosage forms

We support you in development, manufacturing and characterisation of the following dosage forms.

• Solid dosage forms: tablets, coated tablets, mini tablets, dragées, hard capsules, pellets, granules, powders
• Semi-solid dosage forms: creams, oleo and hydrogels, emulsions, self-emulsifying systems (SEDDS, SMEDDs)
• Liquid oral dosage forms: solutions, micro and nanosuspensions, emulsions, lyophilisates

Can' t find the dosage form you are interested in? Or does your product need a special manufacturing process? Feel free to eget in touch with one of our experts about our customised solutions.

Please contact Isabell Joachim, Sales Manager
E-Mail: i.joachim@hwi-group.de, Telefon: +49 7805 401-509

Analysis is a vital core element of medicinal-product development and monitors the success of individual steps in formulation development. We offer the following development analytics:

• Analytical fest-method development/validation
• Stress and stability testing (e.g. according to ICH)
• Batch-release testing
• Updating specifications and analytical test methods as well as regulatory processing (e.g. variation management)

Besides others, we have the following analytical methods and technologies at our disposal:

• Chromatography (HPLC, U(H)PLC, LC-MS, GC, GC-MS) with a wide range of detection options
• Electrophoresis
• In vitro dissolution according to EP and USP (apparatus 1, 2, 4)
• Differential scanning calorimetry (DSC)
• Infrared spectroscopy (FT-IR)
• Laser diffraction for the determination of particle size distributions (PSD)
• Bioanalyzer
• Electron microscopy with energy-dispersive X-ray spectroscopy (SEM-EDX)
• RAMAN spectroscopy (RAMAN CI)
• X-ray microtomography (XMT)
• X-ray diffractometry (XRPD)
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Would you like more information about HWI's analytical capabilities? Take a look at our analytical section.

In addition to our many years of experience, we also have a wide range of technological and analytical equipment for the development, manufacture and characterisation of medicinal products. Besides conventional manufacturing processes, we also offer innovative technologies to meet the challenges of new active substances. Nanotechnology in particular represents a focus within these innovative technologies.

Customised solutions

We offer customised solutions for your product and develop the necessary prototypes in the initial development steps and a robust formulation for the clinical development and later market phase.

Our technologies – solid dosage forms

• Manufacture of granules, direct blends and filling into capsules
• Manufacture of granules, direct blends and processing into tablets and film-coated tablets
• Manufacture of pellets and filling into capsules
• Manufacture of ODTs
• Manufacture of buccal tablets
• Primary (bottles, blister packs, containers) and secondary packaging of powder mixtures, tablets and capsules

Our technologies – semi-solid and liquid dosage forms

• Manufacture of solutions andsuspensions (via wet grinding and high pressure homogenisation)
• Manufacture of emulsions
• Manufacture of oleo- and hydrogels
• Manufacture of lyophilisates
• Manufacture of PLGA-based sterile microparticles
• Primary (vials, syringes, cartridges, bottles, tubes, tins) and secondary packaging of liquid and semi-solid dosage forms
• Manufacture of oral solutions and emulsions and filling into hard capsules
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