Paediatric Biorelevant Media Powder (Infant Gastric and Intestinal) BZ649
Product Code: BZ649
Manufacturer: Biochemazone
Available Pack Sizes: Kits that make 500 mL, 1 L or 5 L
Custom Bulk Quantities Available
Product Overview
Biochemazone Paediatric Biorelevant Media BZ649 are powder kits for dissolution and solubility testing of medicines intended for infants and children. Adult media such as FaSSGF and FaSSIF do not reflect the different stomach pH, bile-salt levels and volumes of young patients, which matters when developing paediatric formulations.
The kits follow the approach of the paediatric media proposed by Maharaj et al. (2016, Pharmaceutical Research), which adjust the adult media for infant physiology. Three media are offered: fasted gastric (pH in the acidic range, about 1.6–3.0 depending on the age group chosen), fasted intestinal (pH about 6.5) and fed intestinal (pH about 5.8). Each kit contains a buffer-salt pack and a pack of bile salt and lecithin. The bile salt (sodium taurocholate) is of animal origin; the lecithin source is stated on the certificate. Fed gastric media are usually made on site from infant formula or milk and are not included.
Check the pH, bile-salt level and osmolality for your age group against the published paper before use; we can prepare media for a specific age group on request. Made under Biochemazone’s ISO 9001 / GMP quality system.
Key Features & Benefits
✅ Infant and Child Physiology – Adjusted from adult biorelevant media
✅ Three Media – Fasted gastric, fasted and fed intestinal
✅ Stated pH – Gastric acidic; intestinal 6.5 and 5.8
✅ Powder Format – Make up only what you need
✅ 24-Month Shelf Life – Stored dry
✅ Low Shipping Cost – Dry packs, not liquids
✅ Batch Certificate – Lot and pH of made-up medium
✅ Made in Canada – Manufactured under ISO 9001 / GMP quality systems
Applications
👶 Paediatric Formulation
• Dissolution of mini-tablets and granules
• Solubility of drugs in infant conditions
• Age-appropriate formulation screening
💊 Biopharmaceutics
• In vitro-in vivo comparison for children
• Food-effect studies with fed media
📋 Regulatory Support
• Paediatric investigation plan studies
• Formulation bridging studies
Usage Areas
- Pharmaceutical formulation laboratories
- Contract research organisations
- Paediatric drug developers
- Biopharmaceutics research groups
- Universities
Typical Properties
- Appearance: White to off-white powders; made-up media clear to slightly opalescent
- pH (made up): fasted gastric about 1.6–3.0 by age group; fasted intestinal about 6.5; fed intestinal about 5.8
- Composition: Buffer salts, sodium chloride, sodium taurocholate and lecithin (intestinal media); pepsin optional in gastric medium
- Form: Dry powder kit for dissolution in purified water
Storage & Stability
- Storage Temperature: 2–30 °C
- Shelf Life: 2 years unopened (dry powder)
- Shipping: Room temperature
- Best kept at 2–8 °C for prolonged storage and stability of the pepsin and lecithin components; storage at 2–30 °C is fine for short-term use
- Use made-up medium within 48 hours
Customization Options
- Media for a specific age group (neonate, infant, child)
- Ready-to-use liquid media
- Fed gastric medium based on infant formula
- Large kits for dissolution laboratories
Ordering Information
BZ649 is available in standard laboratory sizes or OEM/bulk supply formats.
📄 MSDS, Technical Datasheet, and Certificate of Analysis (CoA) available upon request
📧 Email: info@biochemazone.com
🌐 Website: www.biochemazone.com
⚠️ For laboratory testing only. Contains animal-derived bile salt. Not for human or animal use.
