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Dosage Form Development
Serán specializes in developing versatile solid dosage forms, including capsules, tablets, and powder-in-bottle formulations, as well as a wide variety of other engineered solutions tailored for optimal in vivo exposure and scalability from discovery to clinical trials. Serán’s full investment in a shared commitment to the rapid development of better treatments that benefit patients makes us a reliable partner in your drug development journey.
Pioneering Innovation in Dosage Form Development
Using state-of-the-art technologies and industry-leading expertise, Serán helps clients develop a variety of solid dosages, including capsules (enteric or immediate release), tablets (from minitablets to large format caplets), and powder-in-bottle formulations. These forms are meticulously engineered to meet a broad spectrum of formulation approaches, tackling challenges such as solubility issues or the need for extended-release mechanisms. Our goal is to ensure that our innovative techniques enhance the delivery and efficacy of therapeutics.
PHASE-APPROPRIATE, ROBUST FORMULATION STRATEGIES
Translating stable and robust formulation strategies into final delivery forms that offer the sophistication, yet flexibility required to go from Phase I through Commercial can be challenging. Through a combination of material-sparing and material-science based approaches that allow for rapid development of clinically and commercially relevant formulations, Serán works with your team to define and deliver on a target product profile that meets not just the needs for today, but that also offers a clear path to future program objectives. This focus ensures a smooth transition from research to market, making Serán Bioscience a reliable partner in your drug development journey.
Serán provides capsules (enteric or IR), tablets (from minitablets to large format caplets), multi-particulates (coated beads), and powder-in-bottle formulations. Our solid dosage forms are engineered for a wide range of formulation approaches, such as overcoming solubility challenges and enabling extended-release. We complement industry-best production practices with the finest manufacturing equipment available to produce dosage forms that perform predictably and reliably.
Capabilities
- Rational selection of the preferred formulation and delivery system
- Integrated solutions for preclinical – Phase III studies
- Target Product Profile design
- Tailored and customized approaches
- Dosage form development for enabled formulations (ASDs, lipids, modified conventional)
- Material sparing prototype screening for scalable drug product intermediate and drug product
- Multifactorial stability screening
- Dissolution (biorelevant, IDR, release testing)
- PK/PD study design support and data analysis
- Pediatric formulation development
- Modified release / controlled release formulation development
- Oral solid dosage form development
- Particle size reduction
- Tablets – IR, MR/CR, cosmetic or functional coatings, bilayer, fixed-dose combinations
- Capsules
- Multi-particulates – fluid-bed coating
- Drug product analytical method development
- Manufacturing process design & engineering
- Technology transfer
- Nozzle and droplet characterization with a laser diffraction nozzle test stand
Technologies
- Oral solid dosage forms (tablets, mini-tablets, capsules, multiparticulates)
- Oral solutions / suspensions (pre-clinical & clinical)
- Inhalable particulates
- Spray drying
- Hot melt extrusion
- Particle size reduction: Jet and nano-milling
- Tableting (conventional, mini, bilayer)
- Direct blend, dry granulation / roller compaction, wet granulation
- Coating (cosmetic or function, pan and fluid bed)
- Capsule filling
- Pediatric dose forms
- Multiparticulates
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