HAPILA Particle Design

HAPILA GmbH offers its customers a range of practical solutions for development of sophisticated drug substances that includes particle design.

Starting with literature and patent evaluation and following successful feasibility tests, step-by-step particle engineering and development operations include the necessary regulatory activities to obtain early-stage data and information. From the very beginning, particle design and engineering focuses on the accumulation of knowledge in order to create a firm footing for the subsequent steps of value-creation and cGMP manufacture.

Particle Design Service

The particle design service shows a high degree of flexibility to conform with the detailed requirements for an individual client project.

Desired project objectives can include future GMP process undertaken at HAPILA or their transfer to another production location.

The HAPILA approach allows the laboratory to cover a wide range of technologies, categories of substances, physico-chemical processes and accompanying analytical services.

HAPILA has many years of experience in the fields of Particle Design and Particle Engineering, generated during multiple projects for several customers.

Service features

Extensive know-how in technologies for physical conditioning allows HAPILA to focus on optimal bioavailability of ingredients and specifically improve their galenic processing in accordance with customer requirements.

A particular HAPILA strength is in the development of efficient final step procedures in order to selectively constitute crystal structures and particle size distributions. In-depth expertise combined with utilization of modern technical equipment allow HAPILA to guarantee fast and thorough development of final-finishing processes including the creation of the required analytical data, reports and regulatory documentation.

The Particle Design portfolio includes expert solutions in many areas of final-finishing processes, such as wetgrinding, micro-crystallization, dispersion and spray drying.

Particle design applications

HAPILA’s particle design service has a wide range of potential applications that include:

• Specifically designed particle development according to requirements for dosage, release and stability
• Selection of optimal polymorphic design
• Active pharmaceutical ingredients and compounds for pulmonary application with specific particle size distributions
• Micro-particles of difficult-to-micronize ingredients, such as hydrates, esters, low-melting substances, etc.
• Compounds of active substances and auxiliaries for dissolution and permeation enhancement, low and ultra-low dose formulations
• Formation of amorphous active pharmaceutical ingredients

cGxP particle design quality and compliance

Together with its partners, HAPILA ensures reliable process control and analytics, which include analytical assessment of polymorphism, crystallinity and polymorphic purity as well as nano-particle and micro-particle systems.

All HAPILA particle design is carried out at in-house at its GMP and GLP certified laboratories at Gera, Thuringia, in east-central Germany.

When combined with chemical synthesis and purification, HAPILA’s particle design services cover the complete API value-creation chain, enabling it to be a highly efficient bridge-builder between API production and pharmaceutical end-use.