This document discusses sterile dosage forms and parenteral preparations. It defines sterile products as dosage forms that are free of microorganisms. Sterile products include parenteral, ophthalmic, and irrigating preparations. Parenteral preparations include injections and are sterile, pyrogen-free solutions or suspensions intended for administration outside the intestinal tract. Ideal sterile preparations must be sterile, pyrogen-free, clear, stable, and meet other stringent requirements. The document discusses various types of sterile preparations and their formulation considerations including vehicles, preservatives, buffers, and other excipients.

1. STERILE DOSAGE FORM
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PRESENTED BY:
Mr. Ankush P. Jadhav & Miss. Tejashree R. Kedar
M. Pharm (PQA)
Email id: jadhavbrand@gmail.com, tejashrikedar@gmail.com
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2. CONTENTS
INTRODUCTION
ADVANTAGES
DISADVANTAGES
IDEAL REQUIREMENTS
PARENTERALS
TYPES OF STERILE PREPARATION
FORMULATION OF STERILE DOSAGE FORM
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3. INTRODUCTION
STERILE DOSAGE FORM :
• Sterile products are dosage forms of therapeutic agents that are free of viable
microorganism. These includes parenteral, ophthalmic and irrigating
preparation.
• Sterile products are more frequently solutions or suspensions, but may even be
solid pellets for tissue implantation.
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4. ADVANTAGES
• Quick onset of action.
• Suitable for the drugs which are not administered by oral route.
• Useful for unconscious or vomiting patients.
• Duration of action can be prolonged by modifying formulation.
• Suitable for nutritive like glucose & electrolyte.
• Suitable for the drugs which are inactivated in GIT or HCl (GI fluid)
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5. DISADVANTAGES
• Once injected cannot be controlled (retreat)
• Injections may cause pain at the site of injection
• Only trained person is required
• If given by wrong route, difficult to control adverse effect
• Difficult to save patient if overdose.
• Sensitivity or allergic reaction at the site of injection.
• Requires strict control of sterility & non pyrogenicity than other
formulation.
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6. IDEAL REQUIREMENTS
• Sterility (must)
• Pyrogen (must)
• Free from particulate matter (must)
• Clarity (must)
• Stability (must)
• Isotonicity
• Solvents or vehicles used must meet special purity and other standards.
• Restrictions on buffers, stabilizers, antimicrobial preservative. Do not use
coloring agents.
• Must be prepared under aseptic conditions.
• Specific and high quality packaging.
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7. PARENTERALS
para: outside
enteron: intestine (i.e. beside the intestine)
These are the preparations which are given other
than oral routes.
Injections:
These are
Sterile,
Pyrogen free preparations intended to be administered parenterally (outside
alimentary tract).
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8. WHY PARENTERAL?
PARENTERAL ROUTE IS USED B’COZ
1) Rapid action
2) Oral route can not be used
3) Not effective except as injection
4) Many new drugs particularly those derived from
new development in biotechnologically can only be
given by parenteral coz they are inactivated in GIT if given orally.
5) New drugs require to maintain potency & specificity that they are given by
parenteral.
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9. ADVANTAGES:
• Quick onset of action
• Suitable for the drugs which are not administered by oral route
• Useful for unconscious or vomiting patients.
• Duration of action can be prolonged by modifying formulation.
• Suitable for nutritive like glucose & electrolyte.
• Suitable for the drugs which are inactivated in GIT or HCl (GI fluid)
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10. DISADVANTAGES:
• Once injected cannot be controlled (retreat)
• Injections may cause pain at the site of injection
• Only trained person is required
• If given by wrong route, difficult to control adverse effect
• Difficult to save patient if overdose.
• Sensitivity or allergic reaction at the site of injection.
• Requires strict control of sterility & non pyrogenicity than other
formulation.
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11. NECESSITIES OF PARENTERAL PREPARATIONS:
• Sterility (must)
• Pyrogen (must)
• Free from particulate matter (must)
• Clarity (must)
• Stability (must)
• Isotonicity
• Solvents or vehicles used must meet special purity and other
standards.
• Restrictions on buffers, stabilizers, antimicrobial preservative. Do
not use coloring agents.
• Must be prepared under aseptic conditions.
• Specific and high quality packaging.
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12. TYPE OF STERILE PREPARATIONS
a). Parenteral preparations.
Parenteral are divided into two groups.
(i). Small volume parenteral
(ii).Large volume parenteral
(b). Ophthalmic preparations.
• (i). Eye drops
• (ii).Eye ointments
(c). Irrigation solutions.
(d). Dialysis solutions & allergenic extracts.
(e). Diagnostic agents.
(f). Pulmonary drug delivery/Nasal Drug delivery
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13. STERILE PRODUCTS MANUFACTURED AS
VARIOUS DOSAGE FORMS
• Infusion fluids
• Radiopharmaceuticals
• Injections
• Sterile solids: Some drugs do not have sufficient stability in solution to
permit packaging them as injections, they are prepared as dry sterile
solids to placed in solution at the time of use.Sterile suspensions
• Ophthalmic solutions, suspensions and ointments
• Solution for irrigation
• Peritonial dialysis solution
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14. FORMULATION OF STERILE DOSAGE FORM
• Vehicle
• Antimicrobial/preservative
• Solubilizer /wetting agent/ emulsifier
• Buffer
• Bulking agent/tonicity modifier
• Suspending Agent
• Chelating agent
• Stabilizer
• Anti- Oxidant
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15. VEHICLE
• Water/WFI
• Water Miscible vehicles
• Non aqueous vehicles
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16. WHAT IS HIGH PURITY WATER?
• Purified Water (PW)
• Sterile Purified Water (SPW)
• Water for Injection (WFI)
• Sterile Water for Injection (SWFI)
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17. PURIFIED WATER
• USP: “. . .obtained by a suitable process”
• Conductivity ≤ 1.3 µS/cm @ 25º C
• Total Organic Carbon (TOC) ≤ 500 ppb
• Microbial ≤ 100 cfu/ml
• No endotoxin requirement
• IP/EP: “. . .prepared by distillation, by ion exchange, by reverse osmosis or
by any other suitable method”
• JP: “. purified by distillation, ion-exchange treatment, ultrafiltration or
combination of these methods”.
• This article is used as an excipient in the production of non parenteral
preparations and in other applications such as cleaning of equipment and
non-parenteral product. Unless otherwise specified, it is also to be used for
all tests and assays of the Pharmacopoeia
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18. WATER FOR INJECTION (WFI)
• USP: “. . .distillation or a purification process that is equivalent of superior
to distillation”
• Conductivity ≤ 1.3 µS/cm @ 25º C
• Total Organic Carbon (TOC) ≤ 500 ppb
• Microbial ≤ 10 cfu / 100 ml
• Endotoxin requirement < 0.25 EU/ml
• EP: “. . .distillation”
• JP: “. . .distillation. . .or by the Reverse Osmosis Ultra filtration of Purified
Water”
• This article is used as an excipient in the production of parenteral and other
preparations where product endotoxin content must be controlled; it is also
used in other applications such as cleaning of certain equipment and
parenteral product-contact components.
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19. STERILE WATER FOR INJECTION
• Sterile Water for Injection, USP, is sterile, nonpyrogenic, distilled water
in a single dose container for intravenous administration after addition of
a suitable solute. It may also be used as a dispensing container for
diluent use. No antimicrobial or other substance has been added. The pH
is 5.5 (5.0 to 7.0).
• Sterile Water for Injection USP is a clear, colorless, odorless liquid. It is
sterile, hypotonic, nonpyrogenic, and contains no bacteriostatic or
antimicrobial agents. Sterile Water for Injection USP is a diluent or
solvent suitable for intravascular injection after first having been made
approximately isotonic by the addition of suitable solute.
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20. REVERSE OSMOSIS
• Benefits:
• 1. Effectively removes all types of contaminants to some extent
(particles, Pyrogen, microorganisms, colloids and dissolved
inorganics), and is therefore useful as a first purification step.
• 2. Requires minimal maintenance.
• 3. Operation parameters (pressure, temperature, flow rate, ionic
rejection) are easy to monitor.
• Limitations:
• 1. Requires good pretreatment to avoid rapid membrane damage by
water contaminants: scaling.
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22. IDEAL CHARACTERISTICS OF PARENTERAL
SUSPENSION
• It should be sterile and pyrogen free.
• It should be easily drawn into a syringe (syringeability) and readily ejected
from the syringe (injectability)
• Particle size should be small and uniform(less than 10 μm).
• The solid content usually about 0.5-5%.
• The dispersed particles do not settle rapidly after shaking.
• It should be stable and elegance during its shelf life.
• It should be isotonic and non irritating.
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23. REFERENCE
1. Pharmaceutical quality assurance,Manohar A.potdar.Nirali
prakashan,sixth edition.page no.8.1-8.102.
2. Pharmaceutical quality assurance technique,Ramesh
sawant,sandip hapse,second edition,career publication.page
no.112 to 154.
3. www.Wikipedia.com.
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