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Dosage Form Development
Serán Bioscience specializes in developing versatile solid dosage forms including capsules, tablets, and powder-in-bottle formulations, and a wide variety of other engineered solutions tailored for optimal in vivo exposure and scalability from discovery to clinical trials.
Serán Bioscience excels in developing 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.
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 to enable 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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