Color coding for tablet coating

Color coding for tablet coating
 

1. Pink color , Light pink color :      Erythrosine lake pink + Titanium Dioxide

2. Green Color, Lignt green color: 
     a. Lake erythrosine  green + Titanium Dioxide
     b. Quinoline yellow + Lake Brilient Blue + Titanium Dioxide

3. Yellow color , Light Yellow color:
     a. Lake yellow color + Titanium Dioxide
     b. Quinoline yellow  +  Titanium Dioxide

4. Orange color:
     Quinoline yellow +  Erythrosine lake pink + Titanium Dioxide

5. Brown color:
     Quinoline yellow + Red oxide + Titanium Dioxide

6. Violet: 
     Erythrosine lake pink + Indizotin lake + Titanium Dioxide

Emergency Contraceptives Pill

Emergency Contraception:

Emergency contraception is known as a emergency postcoital contraception. Emergency contraception taken after sex, may prevent pregnancy. It also known as morning after pill . 

Emergency contraceptive pills:
Emergency contraceptive pills are prefer to as emergency contraceptives or the morning after pill. This drugs are prevent to ovulation or fertilization and possible post-fertilization implantation of a blastocyst. Emergency contraceptive pills are act after implantation when the fertilized egg is implanted in the womb. It different from medical abortion methods.

Dose:
1. Levonorgestrel  0.75mg per tablet.
    Emergency contraceptive 1 tablet with in 72 hr after intercourse and 2nd tablet 12 hr after the 1st dose.


Side Effect:
-  Upset stomach
-  Vomiting 
-  Stomach pain
-  Fatigue
-  Dizziness and Headache
-  Irregular bleeding
-  Breast tenderness

Mottling in Tablet

Mottling

Definition: ‘Mottling’ is that the term accustomed describe associate unequal distribution of color on a pill, with lightweight or dark spots standing go into associate otherwise uniform surface.

Reason: One reason for marking is also a colored drug, whose color differs from the color of excipients used for granulation of a pill.

The causes and remedies of marking.

  
CAUSES
   
1. A colored drug used in conjunction with colorless or white-colored Excipient.
2. A dye migrates to the surface of granulation whereas drying.
3. Improperly mixed dye, particularly throughout ‘Direct Compression’.
4. Improper mixture of a colored binder resolution.
   

REMEDIES
1. Use applicable colorants.Change the solvent system,
2. Change the binder, Reduce drying temperature and Use a smaller particle size.
3. Mix properly and cut back size if it's of a bigger size to forestall segregation.4. Incorporate dry color additive throughout powder mixing step, then add fine pulverized adhesives like tree and gum and blend well and at last add granulating liquid.

Binding of Tablet

Binding

Definition: ‘Binding’ within the die, is that the term used once the tablets adhere, seize or tear within the die. a movie is created within the die and ejection of pill is hindered. With excessive binding, the pill sides area unit cracked and it should crumble apart.

Reason: Binding is sometimes owing to excessive quantity of wet in granules, lack of lubrication and/or use of worn dies.

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

   
CAUSES:
1.  Too damp granules and extrudes around lower punch.
2.  Insufficient or improper lubricating substance.\
3.  Too coarse granules.   
4.  Too onerous granules for the lubricating substance to be effective.
5.  Granular material terribly abrasive and cutting into dies.
6.  Granular material too heat, sticks to the die.
   
REMEDIES:
1.  Dry the granules properly.
2.  Increase the quantity of lubricating substance or use a more practical lubricating substance.
3.  Reduce granular size, add a lot of fines, and increase the amount of lubricating substance.
4.  Modify granulation. cut back granular size.
5.  If coarse granules, cut back its size. Use wear-resistant dies.Reduce temperature.
6.  Increase clearance if it's extruding.


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

 CAUSES:
    
1. Poorly finished dies.
2. Rough dies owing to abrasion, corrosion.   
3.  Undersized dies. insufficient  clearance.
4. Too much pressure within the pill press.
   
REMEDIES:
1.  Polish the dies properly.
2.  Investigate alternative steels or alternative materials or modify granulation.
3.  Rework to correct size. Increase clearance.
4.  Reduce pressure or Modify granulation.

Method of Sterilization

Methods of Sterilization:

Definition: Sterility is the absence of viable microorganisms. It is essential that the effect of the chosen sterilization procedure on the product (including its final container or package) is investigated to ensure effectiveness and therefore the integrity of the product, which the procedure is valid before being applied in follow. guaranteeing that the selection of the instrumentality is like to permit the optimum sterilization to be applied.

Steam Sterilization:

Applicable Products: Large Volume Parenteral Liquids.

Definition: Sterilization is finished by saturated steam struggling particularly for binary compound preparation. The reference conditions for binary compound preparations ar heating at a minimum of 1210C for quarter-hour. different mixtures of your time & temperature could also be used providing it's been satisfactorily incontestible that the method chosen delivers AN adequate and duplicable level of unwholesomeness once operational habitually among the established tolerances. The procedures and precautions utilized ar like to administer a SAL (Sterility Assurance Level) of 10-6 or higher. Spores of B stearothermophilus ar suggested for validation. there's no growth of the reference microorganisms once the biological indicators are exposed to steam at 121±10C for fifteen min.

Time at Temp. Cycles for Moist Heat Sterilization are given in Table-1

Table-1

Temperature (0C)	Pressure (p.s.i.)			Minimum Holding Time (min)
	(kPa)abs	(lbf/in2)g	(bar)
115-116	172	10	1.7	30
121-123	202	15	2.0	15
126-129	242	20	2.4	10
134-138	304	32	3.0	3
106			1.6	85

      

        Ref: BP 2004, Vol.-4,  and Pharmaceutical Practice

Ethylene Oxide Gas Sterilization:

 

Applicable Products: Infusion Sets, Syringes and Scalp Vein Sets.

Definition: Ethylene Oxide is extremely effective at killing microorganisms and its activity is related to its action as an alkylating agent. Reactive hydrogen atoms on hydroxyl, carboxyl, sulphydril & amino groups can all be replaced with hydroxyethyl groups thus interfering with a wide range of metabolic activities. It is essential that penetration by gas and moisture into the material to be sterilized is ensured and followed to elimination of the gas. where attainable, the gas concentration, ratio, temperature and period of the method area unit measured and recorded.. Measurements are made where sterilization conditions are least likely achieved, as determined at validation. Spores of Bacillus subtilis var. niger are recommended for validation.

Concentration of Ethylene Oxide & Time of Exposure: Manufacturer of ethylene oxide sterilizer recommends, for most purposes, exposure to 850-900 mg/l for 3 h or 450 mg/l for 5 h, at 54⁰C. A powerful vacuum immediately is to be applied after sterilization, e.g. 1.5 kPa (15 mbar) for 2 hours. Also partial vacuums are applied to about 20 kPa (0.2 bar) and then admit sterile air to atmospheric pressure as a flushing agent. This is repeated for 5 to 6 times.

Different Factors responsible for EO Gas sterilization are given in Table-2.

Table-2

EO Gas Sterilizer	Temp.	Pressure (mbar)/ Gas Conc.	Relative Humidity	Time (HoldingTime)
Standard	540C	450 mg/L	50%	5 hours
Standard	540C	850-900mg/L	50%	3 hours
For Biological Indicator	540C	600 mg/L	60%	60 min.
At Infusion Set	450C	800/150 mbar	60%	240 min
At Syringe	310C	900/525 mbar	60%	60 min

   Ref: BP 2004, Vol.-4,  & Pharmaceutical Practice,

Dry Heat Sterilization:

Applicable Particulars: Glass Apparatus.

Definition: Sterilization by dry heat is usually carried out in a hot air oven in which heat is transferred from its source to the load by radiation, convection and to a small extent by conduction. Spores of Bacillus subtilis var. niger are recommended for validation

 Time Temperature Combinations:

·        minimum one hundred eighty degree Celsius  for not less than 30 minutes

·       minimum one hundred seventy degree Celsius for not less than 1 hour

·        minimum one hundred sixty degree Celsius for not less than 2 hours

For Depyrogenation of the Glassware, Treatment is done at 250⁰C for 30 minutes or 200⁰C for 1 hour.

Ref.: Pharmaceutical Practice and BP 2004, Vol.-4.

Binding Agent

Binding Agent

Binder:

 Binders are adhesive materials used to hold powders together as granules & to assist in ultimately holding the compressed tablet together.

Binder is of two types:

-         Solution binder

-         Dry binder.

Solution Binders :

 

-         Starch paste (10-17%)

-         Gelatin solution (10-20%)

-         Sucrose syrup (50-85%)

-         Glucose solution (50% alcohol, 25% glucose and 25% water)

-         Methyl cellulose 4% in alcohol.

-         Ethyl cellulose 5% in alcohol.

-         Starch- acacia paste( starch 5%, acacia 2% in water)

-         Sodium CMC.

-         PVP in aqueous, alcoholic and hydro alcoholic solⁿ

-         Polyethylene glycol.

Dry Binder:

 

-         Cellulose

-         Methyl cellulose

-         PVP

-         Polyethylene Glycol.

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.

Positive Controls

 Positive Controls: 

The medium used for sterilization’s cheeked for its efficacy, to support growth of different organism by adding 10-100 cfu of m gm. This is known as positive control.

DOP Test (Dioctyl Pthanate Test)

DOP Test (Dioctyl Pthanate):  

   

        DOP Test: Dioctyl Pthanate test is used to test the HEPA filters for leaks. The DOP aerosols of 0.28 mms – 0.4 mms size are introduced upstream of the filter and leaks are detected down stream with an aerosol photometer.

Accuracy in Pharmaceuticals

Accuracy:

     Accuracy defines the agreement between the true value and the value found in the testing. The closeness of the result obtained during measurement or analysis to the true value. Bias is a systematic deviation from the true value. It normally refers to the difference between the mean of the set of results of analysis of the unknown are compared with the results obtained from the analysis of standards or reference materials. Accuracy expresses closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found. Accuracy can be determined by comparing the results with those obtained using an alternative method which has already been validated. Accuracy may be determined by applying the procedure to samples of the material to be examined that have been prepared with quantitative accuracy. For analytical methods there are two possible ways of determining the accuracy; the so- called absolute method and the comparative method.