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8/6/2019 Parentralsppt

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PARENTRALS

By.Manohar


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ASPECTS OF FORMULATIONS:

Vehicle in which the drug dissolved (Or) dispersed Adjustment of Is tonicity

Concentration Units

Adjustment of specific gravity

Adjustment of PH

Stabilizers

Preservatives


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Water is the preferred injection vehicle Since the Aq.Prepartionsare well tolerated by the body and easy to administrator

VEHICLES:--- a)Water for injection

b)Water Miscible vehicles for injections

EX:

Ethanol:- Rarely used because of it pharmacological activityand also Co solvent

c)Water Immiscible vehicles for injections

Ex:Fixed Oils

Fattyacid esters

Alcohols

Benzyl benzoate


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Adjustment of Is tonicity Various methods may be used to estimate amount of adjusting

substances required to render a particular solution is tonic with plasma

Calculation is based on freezing point depression, on sodium chloridequivalents , on molar concentration or on Osmolarity


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Concentration of Units

Weight per unit volume Ex: Atropine sulphate Injection 600Micro gram/Ml

Percentage weight per volume Ex: Lignocaine Injection 0.5%

Millimole per unit volume Ex: Potassium chloride solution

2mmol each of K+ and Cl-/ml


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Adjustment of specific gravity

Specific gravity of the solution determine the region of anesthesia

Hypobaric (lower density) Solutions tend to rise

Hyperbaric (Higher density) Solutions to sink relative to thcerebrospinal fluid.


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Adjustment of PH

PH solubility and PH verses Stability are needed for solutionand suspension formulation to assure physical and chemical

stability as well as to max or min solubility

It also voluble for predicting the compatibility of the drugs

with various infusion fluids

Physical and chemical data that should be obtainedMolecular structure

Melting point

Particle size and shape

PH solubility PH stability

Optical activity

Solvate formation


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Stabilizers:

Antioxidant and reducing agents

a) Aq.Injections:

Ex: Sodiummetabisulphite,Sodiumsulphite,Sodiumthiosulphate,Ascorbi

dextrose

b) Oily-InjectionsEx: Propyl gallate,Butylated hydroxy toluene,Bh-anisole and Tocopherol

Chelating agents

Ex: Disodium edetate, Calcium edetate , citric acid and tartaric acid

Other Stabilization methods includes:

Use of buffers to optimum PH


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Preservatives

Ex 1: Aq.Injections-phenol 0.5%, Chlorocresol 0.1%, O-cresol

0.3%, benzyl alcohol 1%,phenylmercuricsalts 0.002%

Ex 2: For Oily Injections phenol, O-cresol or Chlorocresol


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In the pilot plant, a formulae is transformed into a

viable, robust product by the development of areliable and practical method of manufacture that

effect the orderly transition from laboratory to

routine processing in a full scale production

facility.

So pilot plant is the miniature, intermediate plantbetween the laboratory scale and the production

plant.


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Working Area:

Incoming goods stored in special areas for

quarantine.Temperature sensitive products stored in cold

room.

Sampling and weighing of raw materials in

sampling area.

Final product stored in designated area/

Production area ensure full quality compliances.

Technical area for formulation development


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EX:

Parenteral Nutrition Mixture

Total energy supplied in 24 hrs is ..KCAL isML.

Contents:

Nitrogen g

Carbohydrates kcals

Sodium mmol

Potassium mmol

Phosphate mmol

Magnisum mmol

Calcium mmol

Trace Elements:

Cu:Zn:Cr:Mn:F:I:Fe

Vitamins:

A:B Co:C:E:Folate:Biotin

Final Volume ml

Patient ward

Expiry Date:Date:

Prepared By Batch no

Warning: protect from light contains approx 20%

W/V dextrose,donot infuse to rapidly .refregirate until

Ready for use.

Donot make any further additions to this container


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Scale-up for parenterals


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Lay-out of the pilot-plant


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Facility Design

To provide the control of microbial, pyrogen andparticles controls over the production environmentare essential.

Warehousing:All samples should be aseptically taken, which

mandates unidirectional airflow and full operatorgowning.

These measures reduce the potential forcontamination ingress into materials that are yet toreceive any processing at any site.


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Preparation Area:

The materials utilized for the production of thesterile products move toward the preparation areathrough a series of progressively cleanerenvironments.

First the materials are passed through class 100,000 i.e. grade D

environment for presterilization.

Transfer of materials are carried out in air-locksto avoid cross contamination


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The preparation areas are supplied with HEPA filters.

There should be more than 20 air changes per hour

The preparation place is Class 100 area.


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Production area


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Compounding area:The manufacture of parenterals is carried out in

class 10,000 (Grade C) controlled environments inwhich class 100 unidirectional flow hoods areutilized to provide greater environmental controlduring material addition.

These areas are designed to minimize themicrobial, pyrogen, and particulate contamination to

the formulation prior to sterilization.


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Aseptic filling rooms:The filling of the formulations is performed in an

Class 100 environment.Capping and Crimp sealing areas:

The air supply in the capping line should be ofClass 100Corridors:

They serve to interconnect the various rooms. Fillrooms, air locks and gowning rooms are assessedfrom the corridor.

Aseptic storage rooms.Air-locks and pass-throughs:

Air locks serve as a transition points between oneenvironment and another.They are fitted with the UltraViolet lights, spray

systems, or other devices that may be effectivelyutilized for decontamination of materials.

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