1 G&H Meeting 4-5 th October, 2001 G&H Meeting 4-5 th October, 2001 Wellesbourne, UK Wellesbourne, UK WP 7 Pharmaceutics WP 7 Pharmaceutics Objectives.

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Presentation transcript:

1 G&H Meeting 4-5 th October, 2001 G&H Meeting 4-5 th October, 2001 Wellesbourne, UK Wellesbourne, UK WP 7 Pharmaceutics WP 7 Pharmaceutics Objectives / Deliverables Results Outlook 1

2 Objectives / Deliverables Objectives / Deliverables Analytical method / dissolution method Analysis of European garlic market products Publication/Report Development of a novel dosage form 2

3 Results Development Analytical Method Results Development Analytical Method HPLC method for all purposes ColumnHypurity Elite ® C18 (150 x 3 mm; 3µm) Pre-ColumnSupelguard ® LC-18, 20 mm Flow rate0,4 ml/min Temperature25 °C UV-Detektion208 nm Eluents A20 mM phosphate buffer pH mM heptane sulfonic acid Eluents B acetonitrile/20 mM phosphate buffer pH 2.1 (50/50) (v/v) + 10 mM heptane sulfonic acid GradientTime [min]Eluent A [%]Eluent B [%]

4 Results European Market Products Results European Market Products Content of Garlic Ingredients (% m/m) 4

5 Results European Market Products Results European Market Products Content of Garlic Products II (% m/m) 5

6 Results European Market Products Results European Market Products Stability – 18 months storage at ambient conditions 6

7 Results Development Dissolution Method Results Development Dissolution Method Dissolution testing on garlic powder – profile of released compounds (accord. USP: apparatus 2 “paddle method”) Temperature:37 °C Rotation speed: 100 rpm Volume: 500 ml Amount Garlic powder:10 g Dissolution media:66 mM phosphate buffer (for pH 5-9 experiments) 66 mM citrate buffer (for pH 1-5 experiments) Media additives:starch, microcristalline cellulose, cysteine, argenine,tyrosine, glutamic acid, ferric sulfate 7

8 Results HPLC Method “All Purpose” Application

9 Results HPLC Method Results HPLC Method Water/MeOH extraction (enyzme inhibiting conditions) Retention time [min] Absorption (AU) 1 Alliin 2 unknown (Allylcysteine) 3  -Glutamyl-S-allylcysteine 4  -Glutamyl-S-trans-1-propenylcysteine 5  -Glutamyl phenylalanine

10 HPLC Method HPLC Method Water extraction (no enyzme inhibition)

11 Release Profiles Release Profiles Alliin – as a function of pH [min]

12 Release Profiles Release Profiles Allicin as a function of pH [min]

13 Release Profiles Release Profiles Different compounds – without additives [min]