IPS1 - [Sterile Dosage Forms] - Parenterals, Sterile Solutions, Biological Products

Proverbs 16:3

● Parenterals

● Biologicals

● Irrigation Fluids

● Dialysis Solutions

● Pellets or Implants

● Ophthalmic Preparations

Sterile Dosage Forms include:

Parenterals

These refer to injectable routes of administration.

Parenterals

These are STERILE and PYROGEN-FREE preparations.

● Sterility

● Pyrogen-Free

● Isotonicity

● Preparation Environment

● Packaging

● Colorants

● Large Volume Parenterals (LVP)

● Small Volume Parenterals (SVP)

Considerations in Parenteral Preparations

Sterility

[CONSIDERATIONS IN PARENTERAL PREPARATIONS]

The complete ABSENCE of viable microorganism (USP).

Biologic indicator

[CONSIDERATIONS IN PARENTERAL PREPARATIONS]

STERILITY

A biologic indicator is a characterized preparation of specific microorganisms resistant to a particular sterilization process.

Bacillus stearothermophilus

[BIOLOGIC INDICATORS]

Biologic indicator organism for STEAM sterilization

Bacillus stearothermophilus

[BIOLOGIC INDICATORS]

Biologic indicator organism for ETHYLENE OXIDE sterilization

Bacillus subtilis

[BIOLOGIC INDICATORS]

Biologic indicator organism for DRY HEAT sterilization

● Bacillus pumilus

● Bacillus subtilis

● Geobacillus stearothermophilus

[BIOLOGIC INDICATORS]

Biologic indicator organism for IONIZING RADIATION

● Rabbit Test

● LAL Test (Limulus Amebocyte Lysate)

[CONSIDERATIONS IN PARENTERAL PREPARATIONS]

Test for PYROGENS

TRUE

[CONSIDERATIONS IN PARENTERAL PREPARATIONS]

TRUE OR FALSE:

Parenteral solutions should ideally be isotonic with body fluids to prevent irritation or cell damage.

TRUE

[CONSIDERATIONS IN PARENTERAL PREPARATIONS]

TRUE OR FALSE:

Parenteral solutions must be prepared in an environmentally controlled area (cleanroom or laminar airflow hood).

Special hermetic containers

[CONSIDERATIONS IN PARENTERAL PREPARATIONS]

PACKAGING

Parenteral solutions must be placed in _____ containers to maintain sterility and prevent contamination.

TRUE

[CONSIDERATIONS IN PARENTERAL PREPARATIONS]

TRUE OR FALSE:

The use of colorants is strictly PROHIBITED in parenteral formulations.

pH and tonicity

[CONSIDERATIONS IN PARENTERAL PREPARATIONS]

In Large Volume Parenterals (LVP), the ___ must be physiologically compatible with body fluids.

TRUE

[CONSIDERATIONS IN PARENTERAL PREPARATIONS]

TRUE OR FALSE:

Small Volume Parenterals (SVP) are NOT REQUIRED to be isotonic, as the large volume of blood quickly dilutes them.

● Injection

● For Injection

● Injectable Emulsion

● Injectable Suspension

● For Injectable Suspension

Official Types of Injections

Injection

[OFFICIAL TYPES OF INJECTIONS]

Liquid preparations that are drug substances or solutions thereof.

Insulin Injection, USP

[OFFICIAL TYPES OF INJECTIONS]

Example of INJECTION

For Injection

[OFFICIAL TYPES OF INJECTIONS]

Dry solids that, upon addition of suitable vehicles, yield solutions conforming in all respects to the requirements for injections.

Cefuroxime for Injection, USP

[OFFICIAL TYPES OF INJECTIONS]

Example of FOR INJECTION

Injectable Emulsion

[OFFICIAL TYPES OF INJECTIONS]

Liquid preparation of drug substance dissolved or dispersed in a suitable emulsion medium.

Propofol, USP

[OFFICIAL TYPES OF INJECTIONS]

Example of INJECTABLE EMULSION

Injectable Suspension

[OFFICIAL TYPES OF INJECTIONS]

Liquid preparation of solid suspended in a suitable liquid medium.

Methylprednisolone Acetate Suspension, USP

[OFFICIAL TYPES OF INJECTIONS]

Example of INJECTABLE SUSPENSION

For Injectable Suspension

[OFFICIAL TYPES OF INJECTIONS]

Dry solid that, upon addition of suitable vehicle, yields preparation conforming in all respects to the requirements for injectable suspensions

Imipenem and Cilastatin for Injectable Suspension, USP

[OFFICIAL TYPES OF INJECTIONS]

Example of FOR INJECTABLE SUSPENSION

● RAPID action compared with other routes of administration

● OPTIMUM blood levels may be achieved with accuracy

● In emergencies, IV administration of a drug may be LIFESAVING because of the placement of the drug directly into the circulation and the prompt action

Advantages of Intravenous (IV) Administration

● Once a drug is administered, it CANNOT be retrieved.

● In the case of an ADR, the drug CANNOT be easily removed from the circulation.

Disadvantages of Intravenous (IV) Administration

Intramuscular (IM) Route

[COMMON ROUTES OF ADMINISTRATION FOR INJECTION]

Effects are LESS RAPID but generally LONGER LASTING than those obtained from IV administration.

Intramuscular (IM) Route

[COMMON ROUTES OF ADMINISTRATION FOR INJECTION]

Aqueous or oleaginous (oil-based) solutions or suspensions of drug substances may be administered.

Aqueous or oleaginous solutions or suspensions

[COMMON ROUTES OF ADMINISTRATION FOR INJECTION]

These solutions or suspensions may be administered INTRAMUSCULARLY.

Subcutaneous (SC) Route

[COMMON ROUTES OF ADMINISTRATION FOR INJECTION]

This is used for the injection of SMALL amounts of medication.

Subcutaneous (SC) Route

[COMMON ROUTES OF ADMINISTRATION FOR INJECTION]

Maximum amount injected is 1.3 mL.

1.3 mL

[COMMON ROUTES OF ADMINISTRATION FOR INJECTION]

Maximum amount injected in Subcutaneous (SC) Route

Subcutaneous (SC) Route

[COMMON ROUTES OF ADMINISTRATION FOR INJECTION]

Irritating drugs and thick suspensions are NOT SUITABLE for this route.

● Irritating drugs

● Thick suspensions

[COMMON ROUTES OF ADMINISTRATION FOR INJECTION]

These are NOT SUITABLE for SUBCUTANEOUS route.

Intradermal (ID) Route

[COMMON ROUTES OF ADMINISTRATION FOR INJECTION]

Used for DIAGNOSTIC purposes, such as allergy tests or tuberculin tests.

Intradermal (ID) Route

[COMMON ROUTES OF ADMINISTRATION FOR INJECTION]

Typical volume injected is 0.1 mL for diagnostic

0.1 mL

[COMMON ROUTES OF ADMINISTRATION FOR INJECTION]

Typical volume injected for INTRADERMAL route

Small Volume Parenterals (SVPs)

[STERILE SOLUTIONS]

These are available in ampules, vials, or pre-filled syringes.

● Ampules

● Vials

● Pre-filled syringes

[STERILE SOLUTIONS]

Small Volume Parenterals (SVPs) are available in ____

Small Volume Parenterals (SVPs)

[STERILE SOLUTIONS]

These are packaged single-dose or multiple-dose containers (2 mL to 30 mL).

2 mL to 30 mL

[STERILE SOLUTIONS]

Small Volume Parenterals (SVPs) are packaged SINGLE-dose or MULTIPLE-dose containers with ___ mL capacity.

● Heparin Sodium Injection

● Insulin Injection

● Lidocaine HCl Injection

[STERILE SOLUTIONS]

Examples of SMALL volume parenterals (SVPs)

Large Volume Parenterals (LVPs)

[STERILE SOLUTIONS]

These are administered by intravenous infusion to replenish body fluids, electrolytes, or to provide nutrition.

Large Volume Parenterals (LVPs)

[STERILE SOLUTIONS]

These are usually in volumes of 100 mL to 1 L.

100 mL to 1 L

[STERILE SOLUTIONS]

Large Volume Parenterals (LVPs) are usually in volumes of ___ to ___

Large Volume Parenterals (LVPs)

[STERILE SOLUTIONS]

These are employed in MAINTENANCE and REPLACEMENT therapy.

● Maintenance Therapy

● Replacement Therapy

[STERILE SOLUTIONS]

Large Volume Parenterals (LVPs) are employed in __ and ___

Maintenance therapy

[LARGE VOLUME PARENTERALS]

Therapy used for patients ENTERING or RECOVERING from SURGERY.

Maintenance therapy

[LARGE VOLUME PARENTERALS]

Therapy used for patients who are UNCONSCIOUS and UNABLE to take fluids, electrolytes, and nutrition orally.

Total Parenteral Nutrition (TPN)

[LARGE VOLUME PARENTERALS]

This can be administered for patients under MAINTENANCE therapy.

Replacement therapy

[LARGE VOLUME PARENTERALS]

This can be administered for patients who have suffered HEAVY FLUID and ELECTROLYTE LOSS.

Irrigation Solutions

[STERILE SOLUTIONS]

These are NOT injected into the vein but employed OUTSIDE of the circulatory system.

Irrigation Solutions

[STERILE SOLUTIONS]

These are intended to BATHE or WASH wounds, surgical incisions, or body tissues.

Sterile Water for Irrigation, USP

[STERILE SOLUTIONS]

These have SAME requirements as SWFI, except for container design, particulate matter, and labeling.

● Container design

● Particulate matter

● Labeling

[STERILE SOLUTIONS]

Sterile Water for Irrigation, USP have SAME requirements as SWFI, except for ___

● "For Irrigation Only"

● "Not for Injection"

[STERILE SOLUTIONS]

Labeling requirement for Sterile Water for Irrigation, USP

● Peritoneal Dialysis Solution

● Hemodialysis Solution

[STERILE SOLUTIONS]

Types of DIALYSIS solutions

Peritoneal Dialysis Solution

[DIALYSIS SOLUTIONS]

This flows into the peritoneal cavity and removes toxic substances normally excreted by the kidneys.

Hemodialysis Solution

[DIALYSIS SOLUTIONS]

This is used to remove toxins from the blood during hemodialysis treatment.

Biologic products

These are biologic products are preparations derived from living organisms (microorganisms, human or animal tissues, or cells) used for prevention, treatment, or diagnosis of diseases.

● Vaccines

● Toxoids

[BIOLOGICAL PRODUCTS]

Examples of Biologics for ACTIVE immunity

● MMR (Measles, Mumps, Rubella) Vaccine

● Smallpox Vaccine

● Typhoid Vaccine

[BIOLOGICAL PRODUCTS]

Examples of VACCINES

Tetanus toxoid

[BIOLOGICAL PRODUCTS]

Example of TOXOIDS

● Human Immune Sera and Globulins

● Animal Immune Sera

[BIOLOGICAL PRODUCTS]

Examples of Biologics for PASSIVE immunity

● Human immune globulin

● Antirabies serum

[BIOLOGICAL PRODUCTS]

Examples of Human Immune Sera and Globulins

● Tetanus antitoxin

● Antivenin polyvalent (snake venom antiserum)

[BIOLOGICAL PRODUCTS]

Example of Animal Immune Sera

● Intramuscular (IM)

● Intravenous (IV)

● Subcutaneous (SC)

● Intradermal (ID)

● Oral (Polio vaccine)

[BIOLOGICAL PRODUCTS]

Route of Administration for biological products

● Refrigerator: between 2°C and 8°C

● Freezer: temperature of −15°C

[BIOLOGICAL PRODUCTS]

Storage requirement for biological products