Application Note 3 XL Coater

OYSTAR Manesty Kitling Road, Knowsley Merseyside, England L34 9JS Tel: +44 (0)151 547 8000 Fax: +44 (0)151 547 8001 e-mail: sales@oystar.manesty.com Web: www.oystar.manesty.com

Coating of sustained release pellets and tablets using the Manesty XL coater with a range of commercially available coating materials. The Manesty XL coater can be used for a range of sustained release applications for the coating of tablets and pellets. All the commonly used coating materials can be quickly and efficiently processed using both aqueous and organic processes.

Aqueous coating of pellets Paracetamol pellets were manufactured. The powders were dry blended for 4 minutes and wet massed (planetary mixer) for 6 minutes. The mass was then extruded and spheronised (Erweka spheroniser). The pellets were then dried in a fluid bed drier at 50C for 60 minutes. The pellet formulation is as described in Table 1 below
Figure 1 shows the drug release profile from paracetamol pellets tested according to the B.P 1998 Apparatus I (basket apparatus) method at 50 rpm for uncoated and coated (10% w/w gain of Surelease ) pellets

Table 1 Final pellet formulation

Material Avicel PH101 Tablettose

% w/w 40 50

Paracetamol

10

The pellets were coated with Surelease (E-7 19010 Clear) on the Manesty XL coater.

Table 2 Shows the process parameters used to coat the 2kg batch of pellets
Coating suspension Solids concentration (% w/w) Batch size (kg) Inlet temperature (C) Exhaust temperature (C) Pellet bed temperature (C) Spray rate (g/min) Drum speed (r.p.m.) Airflow (m3/hr) Cabinet Depression (Pa) Gun to bed distance (cm) Atomising air pressure (bar) Fan air (bar) Baffle System Gun details Peristaltic tubing Pellet Weight gain (%) Coating time (mins) Coating efficiency (%) Surelease 15 2.0 60 39 41 35 38 16 20 20 361 -60 13 1.0 2.0 Plough-share 1 Manesty with 1.2mm nozzle Silicone; 3.2mm bore; 1.6mm wall 10 75 98.5

Organic solvent coating of paracetamol tablets Eudragit S 12.5 is a material used for controlled release that is commercially available as a 12.5%w/v solution of the polymer dissolved in isopropanol dissolved in organic solvents. Paracetamol tablets (weight 400mg, hardness 160N) were compressed on a Manesty Unipress Diamond rotary tablet press. Two different tablet batch sizes were subsequently coated on the Manesty XL coater

Table 3 Shows the coating suspension formulation details (10%w/w total solids)
Material Eudragit S 12.5 Triethyl Citrate Talc IPA:acetone 60:40 Quantity (g) 4000 50 250 3700

Table 4 Shows the coating parameters, coating times and process efficiencies using Eudragit S 12.5
Coating solution Solids concentration (% w/w) Batch size (kg) Inlet temperature (C) Exhaust temperature (C) tablet bed temperature (C) Spray rate (g/min) Drum speed (r.p.m.) Airflow (m3/hr) Cabinet Depression (Pa) Gun to bed distance (cm) Atomising air pressure (bar) Fan air (bar) Baffle System Gun details Peristaltic tubing Tablet Weight gain (%) Coating Time (mins) Process Efficiency (%) Eudragit S 12.5 10 1.8 45 30 30 22 15 341 -50 13 1.0 1.5 Plough-share 1 Manesty with 0.8mm nozzle Silicone; 3.2mm bore; 1.6mm wall 10 95 99.8

Eudragit S 12.5 10 5 45 30 28 38 - 40 15 341 -50 13 1.0 1.5 Plough-share 1 Manesty with 0.8mm nozzle Silicone; 3.2mm bore; 1.6mm wall 10 137 99.0