Antioxidant

Anti-oxidant: 

It helps to prevent oxidation. Its transfers electron or hydrogen from a substance to an oxidizing agent. 

For example:

Anti-oxidant (reducing agents):  Sodium bi sulphate / Butylated anisole / Thiourea 

Anti-oxidant (blocking agents):  Tocopherol / Ascorbic acid esters.

Synergist : Ascorbic acid (vitamin – C) / Phosphoric acid / Tartaric acid / Citric acid

Lamination in Tablet

Lamination:

Lamination is that the separation of a pill into 2 or additional distinct horizontal layers.

Reason: These issues occur owing to meagerly binder, improper granulation, layering of granules. Pressure personality disorder, defense of air into the entire of the pill, war punch, lack of enough fine powders.


The Causes and Remedies of Lamination associated with ‘Formulation’ (granulation).
  
CAUSES:
   
1.   Oily or waxy materials in granules.   
2.  Too much of hydrophobic material e.g.: Magnesium-stearate.
   
REMEDIES:

1. Modify combining method. Add adsorbent or absorbent.
2.  Use a less quantity of material or amendment the sort of material.

 
The causes and remedies of lamination associated with ‘Machine’ (dies, punches and pill press).

CAUSES:
   
1.   Rapid relaxation of the peripheral regions of the pill, on ejection of the die.
2.   Rapid decompression
   
REMEDIES:

1. Use tapered dies, i.e. higher a part of the die bore has Associate in Nursing outward taper of 3° to 5°.
2.  Use pre-compression step. scale back turret speed and scale back the ultimate compression pressure.

Picking in tablet

 Picking:  

Definition: ‘Picking’ is that the term used once atiny low quantity of fabric from a pill is protrusive to and being removed aloof from the tablet-surface by a punch face.

The problem is additional current on the higher punch faces than on the lower ones. the matter worsens, if tablets ar repeatedly factory-made during this station of tooling owing to the additional and additional material obtaining more to the already stuck material on the punch face.

Reason: choosing is of explicit concern once punch tips have engraving or embossing letters, moreover because the granular material is badly dried.


The causes and remedies of choosing associated with ‘Formulation’ (granulation).


CAUSES
   
1    Excessive wet in granules.   
2   Too little or improper lubrication.  
3  Low freezing point substances, could soften from the warmth of compression and cause choosing.   
4  Low freezing point drug in high concentration.
5  Too heat granules once pressing.  
6  Too much quantity of binder.
   

REMEDIES:

1.  Dry properly the granules, confirm optimum limit.
2.  Increase lubrication; use mixture silicon dioxide as a ‘polishing agent’, so material doesn't hold tight punch faces.
3.  Add high melting-point materials. Use high meting purpose lubricants.
4.  Refrigerate granules and also the entire pill press.
5.  Compress at temperature. Cool sufficiently before compression.
6.  Reduce the number of binder, amendment the kind or use dry binders.


The causes and remedies of choosing associated with ‘Machine’ (dies, punches and pill press).
   
CAUSES:   
1.  Rough or scraped punch faces. 
2.  Embossing or engraving letters on punch faces like B, A, O, R, P, Q, G.   
3.  Bevels or dividing lines too deep.
4.  Pressure applied isn't enough; too soft tablets.
   

REMEDIES:

1.  Polish faces to high luster.
2. Design inscription as massive as attainable. Plate the punch faces with metal to provide a sleek and non-adherent face.
3.  Reduce depths and sharpness.
4.  Increase pressure to optimum.

Self Inspection

What is self inspection?

Self inspections ought to be conducted so as to observe the implementation and compliance with sensible producing observe principles and to propose necessary corrective measures.

Formulation of the Aceclofenac Tablet

Formulation of the Aceclofenac Tablet:

Aceclofenac tablet :  This tablet have round shape and film coated.

Name of  the Raw Materials	Specifications	Quantity
Aceclofenac	BP	100 mg
Maize Starch	BP	75 mg
Povidone-k-30	BP	8.35 mg
Sodium Starch Glycolate	BP	5 mg
Purified Talc	BP	1.65 mg
Lactose	BP	107 mg
Magnesium Stearate	BP	3 mg

Challenge Test

Challenge Test: 

The filter is the ability of a filter to retain microorganisms involving filtration 

of standardized culture containing a large number of small microorganisms.

Negative Controls

Negative Controls: 

Negative controls are the culture media without addition of product sample or microbial challenge. 

The –ve control as used to velocity the sterility of the medium before during and after the incubation 

period of the sterility tests.