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UDS / BDS Delivering solutions, shaping the future.

UDS / BDS - Aptar...UDS are applicable for therapies where a small and very precise amount of active drug formulation is required in a single nasal shot. Where the dose required exceeds

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Page 1: UDS / BDS - Aptar...UDS are applicable for therapies where a small and very precise amount of active drug formulation is required in a single nasal shot. Where the dose required exceeds

UDS / BDS

Delivering solutions, shaping the future.

Page 2: UDS / BDS - Aptar...UDS are applicable for therapies where a small and very precise amount of active drug formulation is required in a single nasal shot. Where the dose required exceeds

UDS are applicable for therapies where a small and very precise amount of active drug formulation is required in a single nasal shot. Where the dose required exceeds 100 µl, BDS are used to deliver two doses nasally.

Key Technical Characteristics

UDS / BDS

UDS liquid UDS powder BDS liquid

LIQUIDS POWDERS

UDS One 100 µl dose Maximum filling volume 140 mm3

BDS Two 100 µl doses

Key Benefits

Disposable devices for single use

Accurate one or two shot delivery

Suitable for liquid and powder drug delivery

Tamper-evident features

Conventional filling techniques

Customized design possible

Key Differentiators

Convenient, ready-to-use primeless devices

One handed actuation, can be used in any position

Drug product and delivery device protected before use

Microbiological integrity of primary container

Patient-independent performance for UDS powder device

Page 3: UDS / BDS - Aptar...UDS are applicable for therapies where a small and very precise amount of active drug formulation is required in a single nasal shot. Where the dose required exceeds

The UDS and BDS nasal spray devices are supported by the following associated Services to expedite your drug product development:

Customized Drug Delivery Solutions

Designed and developed by multi-disciplinary project teams with a customer-centric approach

Quality-by-Design

Analytical Laboratories

Elastomer and plastic extractables, bioburden, silicone oil assay

Full extractable and toxicology packages to support regulatory filing

Physical Laboratories

Aerodynamic sizing and spray characterization

Mechanical, stress and content uniformity testing, moisture content

Non-destructive 3D tomography imaging

IV BE testing Fully validated Nasal Casts

Regulatory Expertise

Dedicated regulatory affairs experts

30 DMFs and over 50 pass NDAs and ANDAs generated Fast approval data packages

Page 4: UDS / BDS - Aptar...UDS are applicable for therapies where a small and very precise amount of active drug formulation is required in a single nasal shot. Where the dose required exceeds

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