Noyes-Whitney Equation:

Noyes-Whitney Equation:

Noyes & Whitney described the quantitative analysis of the amount of drug dissolved from a solid particle as a function of time.

Derivation from Fick’s law of diffusion:

                 

Equation:

                                    D_c /S

                   dc/dt=                  (C_s – C)

                                      h

Where,

c = amount of drug dissolved (mg) in time t(s).

D_c = diffusion coefficient of the drug (cm²s^-1).

S = surface area of drug (cm²)

h = thickness of the diffusion layer liquid film (cm).

C_s = Saturation solubility of the drug (mg.cm^-3).

C = concentration of drug in bulk solution (mg.cm^-3).

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.