Published on October 15, 2014
3. About us Diteba is a global leader in complex analytical and bioanalytical testing, providing solutions and services to the pharmaceutical, biopharmaceutical and nutraceutical industries. Supporting both large and small molecule testing for various dosage forms including solids, semi-solids, liquids, aerosols and other special dosage forms. Our work is focused in several core areas including: In Vitro Release Rate Testing (IVRT) services; stability storage and testing; method development and validation and QC testing at our fully accredited facility. www.diteba.com
4. In vitro release testing • We have superior scientific experience and expertise dedicated to method development and validation of release rate studies for topical formulations, including creams, lotions, ointments, gels, pastes, less viscous solutions and suspensions and transdermal patches for both product development and regulatory purposes. • Our team possesses in-depth expertise in operating Franz Cell and Enhanced Cell systems for semisolid, pulmonary and rectal/vaginal formulations and routinely works with synthetic, biomimesis and tissue membranes, including human and animal skin. • As well, our expertise extends to paddle over disk / cylinder apparatus for transdermal patches. www.diteba.com
5. In vitro release testing Our IVRT services include: • In-process testing for formulation optimization • Quality control, lot to lot variability • Skin penetration, depth profiling and absorption studies for Bioequivalence or Bioavailability evaluation • In Vitro and analytical method development and validation in full compliance with SUPAC-SS and FDA requirements • In Vitro release comparison testing for pre and post-changes formulations • In Vitro-In Vivo Correlation (IVIVC) • OECD Test Method 428 – In Vitro Skin absorption studies • Data interpretation and FDA submission for approval of SUPAC-related changes www.diteba.com
6. In vitro release testing In Vitro Release Testing (IVRT) of semisolids and transdermals using Franz Cell system. • Conforms to FDA Scale-up and Post Approval Changes for Semisolids Guidelines (SUPAC-SS) • Conforms to USP Pharmacopeial Forum Vol. 35(3) May - June 2009 Product Quality and product performance tests for topical and transdermal products • Defined product quality tests in General Chapter <3> • Defined product performance tests <725> www.diteba.com
8. Analytical services Method development, validation and method transfer for: • Potency assay • Related substances (impurities) • Dissolution methods Forced Degradation Studies Cleaning validation testing www.diteba.com
9. Analytical services Quality Control Release Testing • API, Excipients and Finished Products • Organic volatile impurities/residual solvents • Dissolution testing • Preservative testing • ICH stability storage and testing • Physical testing • Compendial or in-house validated methods or sponsor’s methods Formulation Development Testing • In-process testing for formulation optimization • Physical/chemical properties • Spectral characterization • Vehicle compatibility testing • Solubility testing • Excipient compatibility studies • Assay, content and blend uniformity testing for feasibility lots www.diteba.com
11. Bioanalytical testing services Assay method development, validation and transfers Expertise in many proven validated methods to quantitatively measure all types of compounds, small or large molecule, using: • GC-FID • UPLC/MS/MS • HPLC - GFC • UPLC—UV, FLD, ECD • Capillary Electrophoresis (CE) • ELISA (Immunochemistry) • Gel Image Analysis System Feasibility assessments Metabolite identification using LC/MS/MS www.diteba.com
12. Bioanalytical testing services Large Molecule Analysis • Proteins • Peptides • Antibodies • Oligonucleotides • Polysaccharides • Phospholipids, fatty acids • Other www.diteba.com Pre-clinical trial support • Bioanalysis of drug and metabolites in biological fluids • Sample analysis technologies in multiple biological species and matrices for human and animal studies • Toxicokinetic (TK) Clinical Trial Support • Pharmacokinetic (PK) • Bioavailability Studies • Bioequivalence Studies • Drug Interaction Studies
14. Formulation development Testing In addition to providing analytical service support for solid dosage formulations, we also specially support; Semi-solid, ointment, gel, cream, lotion, emulsion, etc. Specialized formulation support, such as liposome, spray, liquid dosage form containing lipid, protein or antibody also available. Testing Includes; • Vehicle compatibility testing • Solubility testing • Excipient compatibility studies • Bench level formulation development contract services available www.diteba.com
16. Physical testing services • Loss on Drying, ROI • Moisture (Karl Fisher Titration & Coulometric) • Color Determination • Deliverable Volume • Density & Specific Gravity • Disintegration • pH and Conductivity • Product & Package Appearance • Tablet Hardness & Friability • Viscosity, Osmolarity, Particulates, TOC www.diteba.com
18. Stability & storage testing • Drug products and substances • CTM, IND, NDA, ANDA Registration batches • Comparator products • Commercial products • Controlled substances and precursors • Formulation evaluation stability testing • Forced degradation studies • Photo stability (UV and Daylight) per ICH Q1B • Temperature cycling (freeze/thaw) • Transportation studies • Protocol design and report writing www.diteba.com
19. Stability & storage testing Long-term and accelerated storage conditions per ICH Guidelines: • 25oC/60% RH • 30oC/65% RH • 40oC/75% RH • 5oC, -20oC, -80oC Special storage conditions available Our temperature/humidity stability chambers are continuously monitored by the fully Validated Rees Scientific CENTRON Monitoring System® . It provides instant data regarding the individual storage condition while ensuring compliance with FDA 21 CFR 11. Our natural gas powered roof top generator ensures continuous power during power failures for all stability chambers, fridges and freezers. www.diteba.com
21. Dissolution testing • Method development and validation • Immediate and controlled release testing • Testing per USP monograph articles or in-house methods • Drug release testing www.diteba.com
22. Key equipment State-of-the-art instrumentation including: • HPLC • UPLC, UPLC-MS/MS • GC-FID • AA • UV, FT-IR • Dissolution systems • Franz Cell and Enhancer Cell systems • ELISA readers • Capillary & Gel Electrophoresis • SDS-Page EP • TOC • Stability chambers • Physical testing equipment www.diteba.com
23. Key equipment expansion • Purchased and qualified a Waters® Xevo™ TQ-S mass spectrometer coupled with the ACQUITY UPLC® I-Class system. Designed for the most demanding quantitative UPLC/MS/MS applications and additional • Doubled our IVRT capacity with the purchase and qualification of multiple Logan Transdermal consoles. www.diteba.com
24. What do our customers think? We recently engaged Diteba to undertake an IVRT study for a topical spray formulation using the finite dose technique and static Franz Diffusion Cells. Not only did they resolve some very difficult technical obstacles, but they completed the project to our complete satisfaction. I am pleased we chose them to be our IVRT partner. www.diteba.com - Dr. Chalil Abu-Gnim, Senior Director, Analytical R&D “ We are very pleased we contracted Diteba for a wide range of GMP/GLP analytical work for both biomolecules and small molecules in various dosage forms and drug development stages, including Phase 1 to Phase 3 products. The work included method development, validation, drug product release and stability programs. Their staff was supportive, well-informed and experienced with the most up-to-date scientific methods, quality practices and regulatory requirements. - Theresa Horne, MSc. – Director, Analytical Chemistry “ ’’ ’’
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