Some­times every second counts – for example during med­ical emer­gen­cies. This is one of the major advan­tages of nasally admin­is­tered drugs: The active ingre­di­ents reach the blood­stream via the nasal mucosa in a very short period of time with a fast onset of effect.

This is why Aptar Pharma’s Unit Dose System (UDS) is based on the nasal admin­is­tra­tion of powder. The sophis­ti­cated design of the one-handed dis­pos­able device enables the reli­able, sys­temic delivery of active ingre­di­ents in pre­cise doses; even when admin­is­tered by the patients themselves.

No matter which active ingre­dient is admin­is­tered with the device, Harro Höfliger offers equip­ment for all phases of devel­op­ment, from purely manual to semi-auto­matic pro­duc­tion, all the way to fully auto­matic turnkey solu­tions. Clin­ical sam­ples can be pro­duced directly at the strategic partner Experic. This coop­er­a­tion between Aptar Pharma, Experic and Harro Höfliger gives phar­ma­ceu­tical cus­tomers the oppor­tu­nity to develop new drugs reli­ably and quickly without having to invest in their own equip­ment in early phases.

They ben­efit from know-how and com­pre­hen­sive ser­vices as early as the pre­clin­ical and clin­ical devel­op­ment stage. In addi­tion, scal­able processes across all devel­op­ment stages ensure resource-saving ­devel­op­ment and max­imum process reliability.

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An impor­tant com­po­nent of the UDS device is the con­tainer. This car­tridge con­tains a so-called “man­drel” made of plastic, a ball and the active ingre­dient. When the patient acti­vates the inhaler, the man­drel pushes the ball upwards and the active ingre­dient is released into the nose.

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Filling and assembly in 3 devel­op­ment stages:

1. Manual production

If phar­ma­ceu­tical cus­tomers want to use Aptar ­Pharma’s device for their for­mu­la­tion, early filling tests can be per­formed directly in Harro Höfliger’s Pharma Ser­vices depart­ment. This allows easy and quick insights into the inter­ac­tion between device, powder for­mu­la­tion and process.

Many ques­tions need to be clar­i­fied during this proof-of-con­cept phase: What quan­tity of powder can be dosed? Can the powder be easily processed? Is the device capable of dis­pensing the desired amount of powder? In order to examine these points, the experts use the purely manual dosing machine Drum TT. In addi­tion, there is equip­ment for the simple, reli­able and repro­ducible final assembly of the con­tainer, for example hand presses for pressing the ball pre­cisely into the con­tainer, and for the stan­dard­ized assembly of all other device components. 

 

2. Semi-auto­matic solution 

The filling process devel­oped in the lab­o­ra­tory is the basis for the next step, which involves a Drum Lab for the semi-auto­matic filling of the device. The com­po­nents are inserted man­u­ally and the con­tainer is filled fully automatically.

With an output of approx­i­mately five to ten UDS devices per minute, the equip­ment is ide­ally suited for the early phases of clin­ical studies. An inte­grated weighing system and the batch report for seam­less doc­u­men­ta­tion of the filling process ensure that all require­ments of phar­ma­ceu­tical devel­op­ment are met.

There­fore the Drum Lab – together with the hand presses and the process exper­tise gained during manual pro­duc­tion – can be trans­ferred to Experic for the pro­duc­tion of clin­ical test sam­ples. Experic not only pro­vides sup­port in terms of pro­duc­tion, but with its exten­sive know-how also in all other chal­lenges related to clin­ical studies, for example in logistics.

 

3. Fully auto­matic production

At present, one system for the fully auto­matic filling of UDS con­tainers is already in oper­a­tion at a customer’s site; another one is at the design stage. The dosing process can be easily scaled on the basis of the pre­vious steps. Also pressing-in of the ball as well as the assembly of the com­po­nents is based on the expe­ri­ence gained from pre­vious devel­op­ment phases. In addi­tion, inte­grated con­trol sys­tems ensure high product quality. With an output of around 50 devices per minute, the fully auto­mated sys­tems are suited for both larger clin­ical studies and com­mer­cial pro­duc­tion. If desired, both appli­ca­tions can be placed directly with Experic.

 

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Photos: Adobe Stock/ac2000, Aptar Pharma