Micro-Sphere - Spray Drying of HPAPIs / APIs - Inhalation Solutions

Micro-Sphere has over ten years' experience in spray drying of aqueous solutions, organic solutions, conventional APIs, and protein, as well as in formulation development, taste masking, enteric coating, and containment.

Micro-Sphere is regularly inspected by Swissmedic (Swiss Health Authority) and audited by its customers, among them multi-national companies.

cGMP compliance is the operating standard for Micro-Sphere and all its production units meet current environmental protection requirements.

Micro-Sphere offers the following services:

• Spray-drying HPAPIs / APIs (organic solvents, teratogenic products, protein, inhalation)
• Scalability of the spray drying process
• Micro-encapsulation
• Nano-emulsion and liposomes
• Enteric coating, taste masking
• Capsule filling
• Formulation development
• Stability studies
• Analytical services
• Analytical method development and validation
• Process development and validation

Spray drying

Micro-Sphere can process HPAPIs / APIs, teratogenic products, protein and peptides by means of three different spray-dryers:

• Büchi B-190 mini spray-dryer
• Niro Mobile Minor™2000: small and pilot-scale spray-dryer
• Niro QSD-3.6 Qualified SD™: small and industrial-scale spray-dryer

All the processes developed in the Niro Mini Mobile Minor are promptly scalable.

Spray-drying is used to manufacture amorphous products as well as to isolate APIs from organic solvent. It is one of the emerging technologies in formulating active substances with particular interest in the field of pulmonary delivery (particle size <5µm), and it is applicable in the formulation of molecules with poor bioavailability in liposomes or emulsions by the technique of high-pressure homogenisation reaching dimensions in the nanometer range (100nm - 800nm). Subsequently the solutions can be dried in the spray dryer on an inert carrier.

Micro-encapsulation

Micro-Sphere has a strong expertise in contract development of liquid and dry micro-encapsulated formulation of API. A laboratory scale machine Hüttlin Unilab-5-DJ is used to develop new or modified generic formulations in the field of micro-encapsulation (enteric coating, pH dependent release, extended release, taste masking) The scale-up to small production batches is performed on Hüttlin HKC-50-DJ with a batch size up to 45kg.

Lacto-Sphere®

Micro-Sphere's know-how is particularly aimed at the development of inhalation products with pulmonary and systemic action.

Lacto-Sphere is lactose for inhalation specifically developed by Micro-Sphere as a carrier for dry powder inhaler (DPI) formulations.

It meets the requirements of the USP/NF, the EP and the JP monographs for lactose monohydrate. The particle size distribution (PSD) is routinely determined by laser diffraction. The narrow PSD confers to Lacto-Sphere unique, remarkable characteristics, essential for a full performing lactose for inhalation.

We sell our Lacto-Sphere and on it we can grant a two-year stability.

• Lacto-Sphere MM3: this fine lactose is produced by micronisation (jet-mill) – D50 -2µm - 4µm
• Lacto-Sphere MM50: it is a medium-sized basic carrier – D50 -40µm - 60µm

Key benefits of Lacto-Sphere are:

• Sourced from BSE / TSE-free country (the US)
• Non-rennet
• Production under cGMP conditions

Nano-emulsions and liposomes

Nano-emulsions and liposomes are utilised in the pharmaceutical sector as well as in the nutraceutical and cosmetic field. Micro-Sphere is equipped with high-pressure filtration, high-speed and high-pressure homogenisers.

Their preparation can be adapted to the oral, topical, nasal, pulmonar or parenteral way of application.

Analytical services

The Micro-Sphere laboratory is equipped with classical analytical instruments: HPLC, HS-GC, TOC off-line, FT-IR, UV-VIS, dissolution apparatus, titration, Karl Fischer, thermobalance (loss on drying). In addition to these, stability cabinets at 25°C, 60% rH and 40°C, 75% rH are installed to perform stability studies as recommended by ICH guidelines.

PSD of fine powders are analysed by Helos Sympatec laser diffraction apparatus equipped with dry and wet cell, by vertical Andersen type impactor and by the next-generation impactor of horizontal type. Powder analysis is also performed by mechanical sieving. Nano-emulsions and dispersions are measured by Helos Sympatec Nanophox.

All of these capabilities are supported by analytical QC and QA team experts who ensure the quality of our services.

About Micro-Sphere

Micro-Sphere was founded in 1998 and started its activity in 2000 in Madonna del Piano (Switzerland) as Micro-Macinazione's daughter company.

In December 2008 the company was taken over by private investors and in January 2010 Micro-Sphere transferred its headquarters to its state-of-the-art facility in Ponte Cremenaga (near Lugano), a few kilometres from the original site.