Formulation of Injections: 

(i) Injectable Solution: 

A range of excipients are included in parenteral solution like antioxidants, antimicrobial agents, buffer, chelating agent etc. to maintain the stability.

Preparation:

  • Dissolve drug (API) & excipient in a vehicle 
  • Filter the solution through a membrane filter and pH is adjusted.
  • Preservatives are added (e.g. Methyl/ ethyl paraben) 
  • Sterilized in autoclave at 121 degree Celsius. 
  • Aseptic filling in a suitable container.

(ii) Injectable Suspension: 

these are the formulations in which active ingredient is suspended in aqueous vehicle containing antimicrobial agents, preservative, suspending agent, and buffer.

They are administered by intramuscular subcutaneous and intradermal routes 
Suspension are never injected by intravenous route.

  • sterilization and milling of active ingredient
  • sterilisation of vehicle
  • Aseptic wetting and dispersion of API.
  • Aseptic milling of bulk suspension 
  • Aseptic filling of bulk suspension in suitable containers. 

(iii) Injectable Emulsion: ---------------


(iv) Sterile Powders: 

Due to instability in water may drugs are formulated as drug powders to use later dissolving water for injection. 

Sterile powders are prepared using these methods:

Sterile Recrystallization: 

  • Drug dissolved in a solvent 
  • Solvent is sterilized 
  • Antisolvent is added to recrystallize the API
  • Filtered & dried.
Advantages: Economic 
Disadvantages: Makes variations in baches 

Lyophilization: 

  •  Solid substance separated from solution by freezing the solvent and evaporating the ice under vacuum. 
  • Filtered and sterilized. 
  • Freeze drying at -50 degree C and dried by Vacuum. 
Advantages: Removal of Water at low temp
Disadvantages: APIs are damaged by stress, Time consuming 

Spray drying: 

In this method the solution of drug is sprayed into a dry chamber where it comes in contact with hot steam of a sterile gas at nearly 100 degree Celsius temperature.


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