Manesty Coating Presentation - 2009

BASF Film Coating Workshop 16th – 17th September 2009 [email protected] 1

Manesty Coating Presentation - 2009 | Brian A Helsdon | 2608091 Manesty Coating Presentation - 2009 | Brian A Helsdon | 2608092

Tablet film coating usingside vented pan technology

Brian A. Helsdon.

Customer Training Manager.

OYSTAR Manesty

Film Coating WorkshopLudwigshafen, 16th -17th September 2009.

Manesty Coating Presentation - 2009 | Brian A Helsdon | 2608093

Side Vented Coating Pan Technology


Coating System



Coating System


Coating System


Key Benefits• High process efficiency

• high air flow

• mixing ability

• Flexibility

• all forms of suspensions

• sugar

• aqueous

• organic solvent

• tablets and pellets

• Reproducibility


Oystar Manesty Coating Systems



Oystar Manesty Coater Range

All fitted with


Oystar Manesty XLTMLab Coater Range(XLTMLab01 - XLTMLab02)


Oystar XLCOTATM Range(150 – 350 – 750)


Oystar PremierTM Range(200 – 500 – 900)



M-tecTM Control System


M-tec Control System


Recipe PC / Supervisor PC(Option)

HMI / PC

PLC

COATERINLET AIRHANDLER

EXHAUSTSYSTEM

SPRAYSYSTEM

CIP FILTER






M-tec Parameters Screen


Inlet and Exhaust Units - HVAC


Inlet Air Handler


Exhaust Filter / Fan Unit



Aqueous Spray / Pump System


Aqueous Film Coating System

Stand alone pump unit.

• Utilises air atomised sprayguns for theapplication of the coating solution.

• All pneumatic supplies contained within thecoater and are controlled via the PLC

• Atomising air pressure

• Fan width air pressure

• Pilot air




Magnetic Solution Flowmeter



Solution Vessel



• Coating solution is delivered tosprayguns via a multi headed peristalticpump.

• Eliminates preferential sprayingbetween sprayguns

• Common inlet solution manifold

• Overpressure monitoring of the solutiondelivery to the sprayguns



• Solution pumpheads are driven via acombined motor and gearbox

• Motor and gearbox are controlled via anVFD / inverter

• A Magnetic Solution Flowmeter isutilised to determine the total solutiondelivery to the sprayguns


Film coating process



Side Vented Coating Pan


Side Vented Coating Pan


Process variables

• Drum mixing

• Airflow

• Inlet, outlet and bed temperature

• Tablet size and shape

• Batch size

• Gun design

• Spray position

• Spray rate

• Droplet size

• Atomising air pressure

• Fan air pressure


Drum Mixing

Factors Influencing mixing efficiency:

• Batch size

• Drum speed

• Baffle design

• Process time



Drum Mixing

• Increased batch size improves mixing due to formation of steeperbed angle and hence increased tablet velocity


Drum Mixing

• Smaller tablets pack together more tightly and rise higher up thedrum, increasing bed angle and hence tablet velocity


Drum speed

Directly influences:

• Mixing

• Tablet abrasion

• Spray rate

• Coating distribution

• Process time


Mixing Baffles Types

Rabbit EarBaffles

Fitted to older machines

PloughshareBaffles

Available on current machinesLow batch version also available

TubularBaffles

Available on current machines

Ploughshare and Tubular are Interchangeable on most machine



Accelacota 10 with rabbit ear baffles


Oystar Manesty ploughshare baffles


Oystar Manesty tubular baffle


Mixing Baffles - Summary

Mixingefficiency

Type ofmixing

Best suited

Rabbit EarBaffles

Low GentleLong processes

Highly friable tablets

PloughshareBaffles

Intermediate ModerateSugar coating and

low batch sizes

TubularBaffles

Very high AggressiveFilm coating of Low

friability tablet



Airflow

• Volume passing through drum

• Balance between inlet and outlet air volumes which control the‘pressure’ in the drum

• Drying efficiency is high in side vented pan

• Airflow can be influenced by tablet size and shape


Temperature

• Adhesion on cohesion aided by applying warm solutions to a warmtablet bed

• High evaporation rate can adversely effect droplet mobility upontablet impingement

• Excessive heating can cause thermal degradation of active

• Consider thermal expansion of cores


Temperature

• Excessive heat can cause spray drying or pinhole formation

• Under steady conditions of inlet temperature, inlet air volume,spray rate and batch size, exhaust temperature is a good guide totablet bed temperature

• In general high temperature = high film stress


Core size and weight

• The pattern of movement of cores in a coater will be influenced bytheir size / weight.

• This in turn may affect film formation due to changes in:

• the time exposed to the atomised droplets when the core passesthrough the spray

• the length of time between each pass through the spray (circulationtime)



Core size and weight

• Core size will influence the amount of coating material needed togive a particular coat thickness.

• For example, decreasing core size will:

• increase the specific surface area (m2/g) to be covered

• increase the amount of polymer needed to reach the required coatlevel (i.e. thickness)

• increase the time for the coating process

• If the droplet size is not tightly controlled, batch variation in releasecharacteristics may result.


Core shape

• During coating the cores will be “tacky” while the applied coatingformulation is drying

• To minimise agglomeration cores must be in constant motion andhave a shape to minimise the contact area.

• Easiest shapes to coat without agglomeration are thereforespheres and most difficult are cubes.


Core shape

• Flat-faced tablets tend to form “stacks” unless great care is takenduring coating to minimise drying times.

• Most tablets for coating should have rounded surfaces - the moreconvex, the less likely is agglomeration.


Core shape

• “Sharp” edges are more vulnerable to physical damage duringcoating.

• Shape of the intagliation may be important in governing ifintagliation bridging occurs.

• Larger and/or deeper intagliations are less susceptible to bridging



Batch size

• Influences mixing efficiency

• Influences air flow

• Can influence process efficiency


Spray rate

• Apply at as fast a rate as possible but avoid overwetting

• Low spray rates can lead to small droplet size which spread poorlyand can lead to orange peel effect

• High spray rates can lead to picking or twinning

• Spray rate can influence process efficiency


Spray Position

• Sprays should be positioned radially so that the spray hits the bedat the undisturbed area between where baffles enter and leave

• Use maximum number of sprays which cover the largest area ofthe bed but which do not overlap

• Gun to bed distance controls droplet size and hence spreading andcoalescence of droplets at tablet bed

• Avoid overwetting or spray drying


Gun Position

• Guns are spaced at equally distanceposition around the centre line of thedrum mesh



Gun Position

1/3

2/3

900 Angle

Drying area


Gun Position

Gun to Bed Distance


Atomising air pressure

• Increasing atomising air pressure decreases mean droplet size

• Increasing atomising air pressure decreases the range in dropletdiameter


Fan air pressure

• Increase fan air pressure changes spray shape from a solid to a flatellipse

• At high fan air pressures droplet size distribution widens

• Different gun designs are influenced differently by changes inatomising or fan air pressure



Increasing fan air pressure


Opti Coat™ spray gun



• Optimum performance & ‘anti-bearding’ cap

• The Opti Coat™ spray gun is the ultimate choicefor Pharmaceutical tablet film coating.


Opti Coat™ spray gun - Key benefits

• ‘Anti-bearding’ system with superior spray pattern

• Enhanced droplet performance

• Low profile shape with integral connections forreduced airflow turbulence



Opti Coat™ spray gun - Key benefits

• Tool free, GMP compliant design

• Retro-fit capability to upgrade existing coating equipment (Manestyand non-Manesty equipment)

• Recirculation option






OYSTAR ManestyKitling Road Knowsley

Merseyside England L34 9JST +44 (0)151 547 8000 F +44 (0) 151 547 8001

[email protected] www.oystar.manesty.com

Manesty Coating Presentation - 2009

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