Oral Solid Dosage Forms
Based on its experience in Drug Product development and manufacturing since 1873, Siegfried offers a broad range of pharmaceutical development services. Products requiring difficult formulations, to demanding narcotic or high potency active pharmaceutical ingredients (API), on through to developing robust manufacturing processes and application of new leading technologies. Additionally, Siegfried is well experienced in developing second and third generation formulations to support product life-cycle management.
Siefgried's Drug Product Development Department is based in Barberà del Vallès (Spain) and consists on Pharmaceutical Development and Analytical Development. Using leading modern equipment & instrumentation, Siegfried is well-suited for developing an extensive range of solid dosage forms.
Some examples from our many completed projects include:
- Tablets using unstable APIs
- Rapid release tablets for poorly soluble APIs
- Hard capsules with delayed release (pellets, mini-tablets)
- Matrix tablets with delayed release
- Oral disintegrating tablets (ODT)
- Chewable tablets
Likewise, the development and manufacture of solid dosage forms is offered for high potency APIs (for materials with occupational exposure limits below 10 µg/m3) in a specifically designed and dedicated area.
Besides processing APIs provided by the customer, Siegfried supports you with the technical knowledge of in-house Drug Substance custom development & manufacturing which develops or optimizes those actives for you. One of the many benefits is that the API specifications are pre-determined in early phase, providing harmonization with the formulation required.
For more information about our development capabilities, please contact Business Development.
Sterile Injectables & Opthalmics
Siegfried Development flexible platform offers the development of standard and complex injectable and ophthalmic formulations.
In addition, Siegfried development experts support you with:
- Evaluation of primary packaging materials
- Selection of the right filtration system
- Identification of the best mixing and dosing system (e.g. peristaltic or rotary piston pumps)
- Study of production material and packaging interactions with your compound (leachables and extractables)
- Evaluation of terminal sterilization effects
Clinical trial material for sterile dosage forms is manufactured at our Irvine (USA) and Hameln (Germany) facilities, serving all the countries where your clinical study is carried over.