Ph116 - Manufacture of Solutions

UNIVERSITY OF SANTO TOMAS - LEGAZPI
COLLEGE OF HEALTH SCIENCES - BATCH 2024

PHARMACEUTICAL MANUFACTURING - LECTURE
MANUFACTURE OF SOLUTIONS AQUEOUS SOLVENT – USP Waters
Solution Purified Water
Prepared by:
● A homogenous mixture of two or more
● Distillation
components prepared by dissolving a solid,
● Reverse osmosis
liquid, or gas in another liquid. ● Ion exchange
● In pharmacy context: liquid dosage forms ● UV light (can
destroy/kill
Advantages microorganisms)
● Filtration
● Drug is already dissolved in the solvent system
○ During the process of absorption, the Water for Injection, USP
process of liberation and dissolution
Purified water which is free of
are already skipped. pyrogens
● Treatment of anaphylaxis
○ anaphylaxis : extreme form of Pyrogen: fever-causing
allergies, hypersensitivity reactions metabolites of bacteria
● Readily available for absorption
○ API is already dissolved in the solvent Depyrogenation Techniques:
● Provide dose uniformity, and specific volumes ● Ion exchange
chromatography
of the liquid
● Ultrafiltration (for
● provide accurate measurement endotoxins > 300,000
● Easily administered Da)
● Easily swallowed ● Distillation
● Oxidation (hydrogen
General Formula peroxide)**
● Acid-base hydrolysis**
● API – Soluble or miscible or at least partly ● Heating (Dry Heat
soluble or partly miscible in the vehicle Oven at 250C in 30
mins)*
(solvent)
● Sodium Hydroxide**
● Solvent/Vehicle (majority of your formulation)
○ Water : most commonly used *preferred
● Viscosity enhancer/controllers **not preferred
○ for stability purposes; delivery of drug;
prevents leakage Sterile Water for Injection,
● Buffer/Acidifiers/pH adjusters USP
○ stability purposes; there are sensitive
Sterilized water for injection
APIs; to achieve a certain pH of the
and packaged single dose
solution (pH requirement) containers (USP limit: 1000
● Sweetening agents mL)
○ for syrups; to improve palatability
(drugs are bitter in nature) Most difficult to prepare (due
● Others: Co-solvents, Solubilizer, Preservatives*, to the sterilization techniques)
Flavor, Colorant**, Perfume***
Used for extemporaneous
compounding (IM and IV)
*for non sterile dosage forms
**for elegance; to mask disagreeable color
***volatile oils; improve aromatic odor
1 | A.Y. 2022-2023
Bacteriostatic Water for

Injection, USP
Sterile water for injection with

bacteriostatic agents* and
packaged in single or multiple
dose containers (USP limit:
30mL)
Benzyl Alcohol
Extemporaneous parenterals
*inhibits growth of bacteria
Filling Methods
MANUFACTURING
Depends on several factors
I. Product (viscosity, surface tension, foam

producing qualities, compatibility with the
type of material used in the machine)
II. Package (size,shape, type)
III. Product output
1. Gravimetric filling
2. Volumetric filling
3. Constant level filling
a. Vacuum filling
b. Gravity-vacuum filling
c. Pressure-vacuum filling
QUALITY CONTROL
Purpose of Ageing: In-Process QC Tests
● To allow complete reaction ● Viscosity

● To allow precipitation ● pH
● To allow (even) distribution (of API) ● Specific Gravity
● Pourability
● Organoleptic Properties
How long? Depends on the validation of the process
● Bulk Volume
(usually hours to days)
ASEAN GUIDELINE ON STABILITY STUDY OF DRUG PRODUCT
2 | A.Y. 2022-2023
Finished Product QC Tests

Gravimetric Filling Systems measure the precise
weight of the fill material through the use of a
Deliverable Volume (250mL and above container) balance. The filling is electronically controlled and
● Assures that oral liquids, when transferred usually programmed, ensuring an accurate amount
from the original container, delivers the of product is placed in the desired container each
volume declared on the label. time
● Applicable for products packaged not less than
250 mL containers individually Volumetric filling machines fill your bottles or
containers with a precise volume of your liquid
product, regardless of what this may visually mean
PROBLEMS
for the appearance of the final fill-level.
● Liquids, creams and ointments may be Constant Level Filling : each container is filled to the
particularly susceptible to contamination same level hence it is also called as fill-to-a- level
(microbial and others) during manufacture. method. It uses the container for controlling the
Therefore, special measures must be taken to filling of each unit which means that any change in
prevent any contamination. size of the container causes change in the net fill per
unit.
● Instability
○ compatibility of API with excipient/s
● Many drugs are insoluble in water
● Liquids are bulky and less easy for the patient
to carry
● More expensive to transport (cost of
medicines)
3 | A.Y. 2022-2023

Ph116 - Manufacture of Solutions

Uploaded by

Copyright:

Available Formats

Ph116 - Manufacture of Solutions

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Ph116 - Manufacture of Solutions

Uploaded by

Copyright:

Available Formats

UNIVERSITY OF SANTO TOMAS - LEGAZPI

COLLEGE OF HEALTH SCIENCES - BATCH 2024

MANUFACTURE OF SOLUTIONS AQUEOUS SOLVENT – USP Waters

Solution Purified Water

Bacteriostatic Water for

Sterile water for injection with

*inhibits growth of bacteria

I. Product (viscosity, surface tension, foam

Purpose of Ageing: In-Process QC Tests

● To allow complete reaction ● Viscosity

Finished Product QC Tests

You might also like