Report on Nuvista Pharma Ltd (Part-10)

COATING PROBLEM

v  Logo bridging

Possible causes

1.      Inadequate adhesion of the film coating surface characteristics of the products being coated (e.g. hydrophobic substrate).

2.      Inappropriate design of logo (e.g. too detailed or fine)

3.      Insufficient plasticizer in film/ high internal stress.

Solutions

1.      Select opadry II formulation for improved adhesion characteristics

2.      Modify core formulation to include more hydrophilic ingredients (where possible / or increase core porosity)

v  Logo in filling

Possible causes

1.       Inappropriate design of logo (e.g. to detailed or fine)

2.       In filling of logo with spray dried coating material

3.      Logo disappearance can be due to erosion of tablet surface around logo.

Solutions

1.      See solutions for logo bridging

2.      Reduce erosion potential by either reformulating core. Changing logo design or modifying curvature of faces of tablet.

3.      Reduce spray drying potential by increasing spray rate.

v  Picking / sticking

Possible causes

1.      Spray rate too high

2.      Inadequate drying condition

3.      Pan speed too low

Solutions

1.      Reduce spray rate

2.      Improve drying conditions

3.      Increase pan speed

4.      Increase atomization air pressure / volume

v  Twinning

           Possible causes

1.      Spray rate too high

2.      Pan speed too low

3.      Inappropriate tablet shape

4.      Tacky coating formulation

5.      Spray guns too close to tablet bed.

Solutions

1.      Reduce spray rate and / or increase atomizing efficiency

2.      Increase pan speed

v  Core erosion

Possible causes

1.      Inherent softness or high friability of  core

2.      Excessive pan speed in coating process

3.      Spray rate too low

4.      Low solids content of spray solution

  Solutions

Improve mechanical strength of core by increasing compaction force, modifying core formulation or changing process by which core is produced (e.g. use granulation process instead of direct compression)

v  Peeling

Possible causes

1.      Low mechnical strength of coating

2.      Poor adhesion of coating to tablet surface

Solutions

1.      Select Opadry with improved mechanical strength

2.      Select Opadry with improved adhesion characteristics

v  Orange peel /roughness

           Possible causes

1.      Viscosity of coating liquid too high

2.      Poor atomization of coating liquid

3.      Drying condition excessive

4.      Overwetting (causing coating to rub)

Solutions

1.      Reduce solid contents of coating liquid

Increasing atomizing air pressure /volume

CAPSULE

Capsule is a solid dosage form, in which medicaments are enclosed in a capsule shell, made from gelatin. Generally we use empty hard gelatin shell. Capsules shells are made of two parts-body and cap. Medicaments in the form of powders or granules, are filled into the body and locked with cap-the form of dosage form is called capsule.

Problem during capsule manufacturing:

Usually the following problem occurs during encapsulation:

• Capsule shell size variation
• Capsule shell color variation
• Shell lock
• Pore of shell
• Shell cutting is not correct
• Two shell attaches to each other
• Pellets become clump together
• Charge develops on pellets surface on frequent agitation and they stick to each other hampering the flow rate. By using talc, mg stearate the following problem can be resolve.
• Weight variation

 Equipment used in Sterile Manufacturing:-

1. Capsule Filling machine ……….  P+am (India)