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Dr. Prashant L. Pingale
Associate Professor-Pharmaceutics
GES’s Sir Dr. M. S. Gosavi College of Pharmaceutical Education and Research,
Nashik
General Requirements of
Sterile Products
Learning outcomes
 On successful completion of this unit learners shall able to:
 Explain General Requirements of Sterile Products
2
 Vehicle
 Types of parenteral additives:
 Antimicrobials
 Antioxidants
 Buffers
 Bulking agents
 Chelating agents
 Protectants
3
 Solubilizing agents
 Surfactants
 Tonicity adjusting agents
 Antifungal agents
 Hydrolysis inhibitors
 Antifoaming agents
Therapeutic ingredients
Insulin
 Antibiotics
 Anticancer
 Steroids
 Vaccines
 Antipyretic
 Analgesics
 Anti- inflammatory
 LVP’s like Dextrose, NaCl or combination etc….
4
Ideal properties of sterile dosage forms
 Sterility:
 Sterile preparations should be free from all types of microorganisms.
 Ophthalmic formulations must be especially free from Pseudomonas aeruginosa, gram negative
bacteria which is commonly found in ophthalmic formulations and can cause serious infections
to cornea.
 Isotonicity:
 Parenteral preparations should be isotonic with blood plasma and body fluids.
 Ophthalmic formulations must be isotonic with lachrymal secretions.
 Free from pyrogens:
 Sterile formulations must be free from pyrogens and toxins.
 These products must pass pyrogen test as pyrogens are responsible for rise in body
temperature.
5
Ideal properties of sterile dosage forms
 Free from foreign particles:
These products must be free from foreign particles, dust, fibres and must pass clarity
test.
 pH of ophthalmic formulations:
pH of tears is about 7.4. pH plays crucial role in therapeutic activity, solubility, stability
and comfort to the patient.
 Stability:
Physical and chemical stability of sterile formulations should be maintained during
storage.
6
Types of Parenteral Products7
Small Volume Parenterals
(SVP)
Large Volume Parenterals
(LVP)
Difference in SVP and LVP8
Categories of parenteral preparations
 The different categories of parenteral preparations include:
Injections;
Intravenous infusions;
Powders for injections or intravenous infusions;
Concentrates for injections or intravenous infusions;
Implants
9
Vehicles for Injection
 Aqueous vehicles:
 Frequently, isotonic (to blood) to which drug may be added at time of use.
 Water-miscible vehicles:
 Portion of the vehicle in the formulation,
 used primarily to effect solubility of drugs and/or reduce hydrolysis
 ethyl alcohol; polyethylene glycol (liquid) and propylene glycol
 Nonaqueous vehicles:
 Fixed oils (vegetable origin, and rancid resistance) used in hormone preparations
10
Aqueous vehicles
 Water for Injection (WFI) USP
 Sterile Water for Injection (SWFI)
 Bacteriostatic Water for Injection USP
 Sterile Water for Irrigation USP
 Sterile Water for Inhalation USP
11
Water for Injection (WFI) USP
 Highly purified water used as a vehicle for injectable
preparations which will be subsequently sterilized.
 USP requirement: NMT 10 ppm (1 mg/100 ml) of total
solids.
 pH of 5.0 – 7.0 .
 WFI may be prepared by either distillation or reverse
osmosis.
 Stored in chemically resistant tank.
 Used as solvent for preparation of parenteral solutions.
 It is not required to be sterilized and pyrogen free.
 It is intended to be used within 24 hours after collection.
 The water should be collected in sterile and pyrogen free
containers.
12
Specifications for WFI as per USP
Sterile Water for Injection (SWFI)
 Sterile Water for Injection is Water for Injection packaged and rendered sterile.
 Is water for injection that is sterilized and packaged in single dose container of type1 and 2 glass.
 It is used for extemporaneous prescription compounding and as a sterile diluent for parenteral
products.
 It may also be used for other applications when
Access to a validated water system is not practical, or
Where only a relatively small quantity is needed.
 Sterile Water for Injection is packaged in single-dose containers not larger than 1 L.
 Multiple- dose containers not exceeding 30 ml.
 They are permitted to contain higher levels of solid than WFI because of possible leaching.
 Used for washing wounds, surgical incisions or body tissues.
13
Why TDS in SWFI
is more than
WFI?
Bacteriostatic Water for Injection USP
 Water for Injection, packaged and rendered sterile, to which one or more suitable
antimicrobial preservatives are added or Is sterile water for injection that contains one
or more suitable antimicrobial agents.
 Sterile water containing 0.9% benzyl alcohol that is used to dilute or dissolve
medications.
 It is intended to be used as a diluent in the preparation of parenteral products.
 These are typically for multi-dose products that require repeated content withdrawals.
 It also packaged in single or multiple dose container of type 1 and 2 glass.
 It may be packaged in single-dose or multiple-dose containers not larger than 30 mL.
14
Sterile Water for Irrigation USP
 Water for Injection packaged and sterilized in single-dose containers which may be
larger than 1 L.
 Is water for injection that is sterilized and suitably packaged.
 They allow rapid delivery of their contents.
 Due to its usage, Sterile Water for Irrigation is not required to meet Particulate Matter
in Injections.
 It contains no antimicrobial agents or other added substances.
15
Sterile Water for Inhalation USP
 Is Water for Injection that is packaged and rendered sterile.
 It is intended for use in inhalators and in the preparation of inhalation solutions.
 This monograph has no requirement to meet.
 It carries a less stringent specification for bacterial endotoxins than Sterile Water for
Injection.
 Therefore is not suitable for parenteral applications.
16
Water-miscible vehicles
 A number of solvents that are miscible with water have been used as a portion of the
vehicle in the formulation of parenterals.
 These solvents are used to solubilize certain drugs in an aqueous vehicle and to
reduce hydrolysis.
 The most important solvents in this group are ethyl alcohol, liquid polyethylene glycol
and propylene glycol.
 Ethyl alcohol is used in the preparation of solutions of cardiac glycosides and the
glycols in solutions of barbiturates, certain alkaloids, and certain antibiotics.
 Such preparations are given intramuscularly.
 There are limitations with the amount of these co-solvents that can be administered,
due to toxicity concerns, greater potential for hemolysis, and potential for drug
precipitation at the site of injection.
 Formulation scientists needing to use one or more of these solvents must consult the
literature and toxicologists to ascertain the maximum amount of co-solvents allowed
for their particular product.
17
Non-Aqueous Vehicles
 The most important group of non-aqueous vehicles is the fixed oils.
 The USP provides specifications for such vehicles, indicating that the fixed oils must
be of vegetable origin so they will metabolize, will be liquid at room temperature,
and will not become rancid readily.
 The USP also specifies limits for the free fatty acid content, iodine value, and
saponification value (oil heated with alkali to produce soap, i.e., alcohol plus acid
salt).
 The oils most commonly used are corn oil, cottonseed oil, peanut oil, and sesame oil.
 Fixed oils are used as vehicles for certain hormone (e.g., progesterone, testosterone,
deoxycorticosterone) and vitamin (e.g., Vitamin K, Vitamin E) preparations.
 The label must state the name of the vehicle, so the user may beware in case of
known sensitivity or other reactions to it.
18
Antimicrobials
 Added for fungistatic or bacteriostat action or concentration.
 Used to prevent the multiplication of micro-organisms.
 Examples:
 Benzyl alcohol -- 0.5 – 10 %
 Benzethonium chloride -- 0.01 %
 Methyl paraben -- 0.01 – 0.18 %
 Propyl paraben -- 0.005 – 0.035 %
 Phenol -- 0.065 – 0.5 %
19
Preservatives
 Multidose containers must have preservatives unless prohibited by monograph.
 Large volume parenteral must not contain preservative b’coz it may be dangerous
to human body if it contain in high doses.
Antioxidants
 Used to protect product from oxidation.
 Acts as reducing agent or prevents oxidation.
20
A) Reducing agent:
 Ascorbic acid -- 0.02 – 0.1 %
 Sodium bisulphate -- 0.1 – 0.15 %
 Sod. Metabisulphite -- 0.1 – 0.15 %
 Thiourea -- 0.005 %
C) Synergistic:
 Ascorbic acid ,
 Citric acid ,
 Tartaric acid.
B) Blocking agents:
 Ascorbic acid esters -- 0.01 – 0.015%
 BHT -- 0.005 – 0.02 %
D) Chelating agent:
 EDTA -- 0.01- 0.075 %
Example
Buffers
 Added to maintain pH,
 Change in pH may causes degradation of the products
 Acetates, citrates, phosphates are generally used.
Factors affecting selection of buffers:
 Effective range,
 Concentration
 Chemical effect on the total product
Examples:
 Acetic acid, adipic acid, benzoic acid, citric acid, lactic acid
 Used in the conc. of 0.1 to 5.0 %
21
Stabilizers
 As parenterals are available in solution form they are most prone to unstabilize.
 Used to stabilize the formulation
 Maintain stable
Examples:
 Creatinine – 0.5- 0.8 %
 Glycerin – 1.5 – 2.25 %
 Niacinamide – 1.25 -2.5 %
 Sodium saccharin – 0.03 %
 Sodium caprylate – 0.4 %
22
Chelating agents
 Used to form the complex with the metallic ions present in the formulation so that the
ions will not interfere during mfg. of formulation.
 They form a complex which gets dissolved in the solvents.
Examples:
 Disodium edetate – 0.00368 - 0.05 %
 Disodium calcium edetate - 0.04 %
23
Solubilizing agents
 Used to increase solubility of slightly soluble drugs
 They acts by any one of the following:
 Solubilizers,
 Emulsifiers or
 Wetting agents.
Examples:
 Dimethylacetamide, Ethyl alcohol, Glycerine, Lecithin, PEG – 40 + Castor oil, PEG – 300,
Polysorbate 20, 40, 80
24
Inert gases
 Another means of enhancing the product integrity of oxygen sensitive medicaments is
by displacing the air the solution with nitrogen or argon.
 This technique may be made more effective by first purging with nitrogen or boiling
the water to reduce dissolved oxygen.
 The container is also purged with nitrogen or argon before filling and may also be
topped off with gas before sealing.
25
Tonicity adjusting agents
 Used to reduce the pain of injection.
 Buffers may acts as tonicity contributor as well as stabilizers for the pH.
 Isotonicity depends on permeability of a living semipermeable membrane
 Hypotonic : swelling of cells (enlargement)
 Hypertonic: shrinking of cells (reduction)
Examples:
 Glycerin, Lactose, Mannitol, Dextrose, Sodium chloride, Sorbitol
26
Surfactants
 Used:
 to dispose a water-insoluble drug as a colloidal dispersion.
 for wetting powder.
 to prevent crystal growth in a suspension.
 to provide acceptable syringability.
 for Solubilizing steroids and fat-soluble vitamins.
 Example:
 Polyethylene 0.1 to 0.5%
 Sorbitan monooleate 0.05 to 0.25%
27
Protectants
 Used to protect against loss of activity caused by some stress
 Used to prevent loss of active ingredients by adsorption to process equipment
or to primary packaging materials
 Protectants primarily used in protein formulations.
Examples:
 Sucrose, glucose, lactose, maltose, trehalose (2 to 5%)
 Human serum albumin (0.1 to 1%)
28
General requirements of parenteral preparations

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General requirements of parenteral preparations

  • 1. Dr. Prashant L. Pingale Associate Professor-Pharmaceutics GES’s Sir Dr. M. S. Gosavi College of Pharmaceutical Education and Research, Nashik General Requirements of Sterile Products
  • 2. Learning outcomes  On successful completion of this unit learners shall able to:  Explain General Requirements of Sterile Products 2
  • 3.  Vehicle  Types of parenteral additives:  Antimicrobials  Antioxidants  Buffers  Bulking agents  Chelating agents  Protectants 3  Solubilizing agents  Surfactants  Tonicity adjusting agents  Antifungal agents  Hydrolysis inhibitors  Antifoaming agents
  • 4. Therapeutic ingredients Insulin  Antibiotics  Anticancer  Steroids  Vaccines  Antipyretic  Analgesics  Anti- inflammatory  LVP’s like Dextrose, NaCl or combination etc…. 4
  • 5. Ideal properties of sterile dosage forms  Sterility:  Sterile preparations should be free from all types of microorganisms.  Ophthalmic formulations must be especially free from Pseudomonas aeruginosa, gram negative bacteria which is commonly found in ophthalmic formulations and can cause serious infections to cornea.  Isotonicity:  Parenteral preparations should be isotonic with blood plasma and body fluids.  Ophthalmic formulations must be isotonic with lachrymal secretions.  Free from pyrogens:  Sterile formulations must be free from pyrogens and toxins.  These products must pass pyrogen test as pyrogens are responsible for rise in body temperature. 5
  • 6. Ideal properties of sterile dosage forms  Free from foreign particles: These products must be free from foreign particles, dust, fibres and must pass clarity test.  pH of ophthalmic formulations: pH of tears is about 7.4. pH plays crucial role in therapeutic activity, solubility, stability and comfort to the patient.  Stability: Physical and chemical stability of sterile formulations should be maintained during storage. 6
  • 7. Types of Parenteral Products7 Small Volume Parenterals (SVP) Large Volume Parenterals (LVP)
  • 8. Difference in SVP and LVP8
  • 9. Categories of parenteral preparations  The different categories of parenteral preparations include: Injections; Intravenous infusions; Powders for injections or intravenous infusions; Concentrates for injections or intravenous infusions; Implants 9
  • 10. Vehicles for Injection  Aqueous vehicles:  Frequently, isotonic (to blood) to which drug may be added at time of use.  Water-miscible vehicles:  Portion of the vehicle in the formulation,  used primarily to effect solubility of drugs and/or reduce hydrolysis  ethyl alcohol; polyethylene glycol (liquid) and propylene glycol  Nonaqueous vehicles:  Fixed oils (vegetable origin, and rancid resistance) used in hormone preparations 10
  • 11. Aqueous vehicles  Water for Injection (WFI) USP  Sterile Water for Injection (SWFI)  Bacteriostatic Water for Injection USP  Sterile Water for Irrigation USP  Sterile Water for Inhalation USP 11
  • 12. Water for Injection (WFI) USP  Highly purified water used as a vehicle for injectable preparations which will be subsequently sterilized.  USP requirement: NMT 10 ppm (1 mg/100 ml) of total solids.  pH of 5.0 – 7.0 .  WFI may be prepared by either distillation or reverse osmosis.  Stored in chemically resistant tank.  Used as solvent for preparation of parenteral solutions.  It is not required to be sterilized and pyrogen free.  It is intended to be used within 24 hours after collection.  The water should be collected in sterile and pyrogen free containers. 12 Specifications for WFI as per USP
  • 13. Sterile Water for Injection (SWFI)  Sterile Water for Injection is Water for Injection packaged and rendered sterile.  Is water for injection that is sterilized and packaged in single dose container of type1 and 2 glass.  It is used for extemporaneous prescription compounding and as a sterile diluent for parenteral products.  It may also be used for other applications when Access to a validated water system is not practical, or Where only a relatively small quantity is needed.  Sterile Water for Injection is packaged in single-dose containers not larger than 1 L.  Multiple- dose containers not exceeding 30 ml.  They are permitted to contain higher levels of solid than WFI because of possible leaching.  Used for washing wounds, surgical incisions or body tissues. 13 Why TDS in SWFI is more than WFI?
  • 14. Bacteriostatic Water for Injection USP  Water for Injection, packaged and rendered sterile, to which one or more suitable antimicrobial preservatives are added or Is sterile water for injection that contains one or more suitable antimicrobial agents.  Sterile water containing 0.9% benzyl alcohol that is used to dilute or dissolve medications.  It is intended to be used as a diluent in the preparation of parenteral products.  These are typically for multi-dose products that require repeated content withdrawals.  It also packaged in single or multiple dose container of type 1 and 2 glass.  It may be packaged in single-dose or multiple-dose containers not larger than 30 mL. 14
  • 15. Sterile Water for Irrigation USP  Water for Injection packaged and sterilized in single-dose containers which may be larger than 1 L.  Is water for injection that is sterilized and suitably packaged.  They allow rapid delivery of their contents.  Due to its usage, Sterile Water for Irrigation is not required to meet Particulate Matter in Injections.  It contains no antimicrobial agents or other added substances. 15
  • 16. Sterile Water for Inhalation USP  Is Water for Injection that is packaged and rendered sterile.  It is intended for use in inhalators and in the preparation of inhalation solutions.  This monograph has no requirement to meet.  It carries a less stringent specification for bacterial endotoxins than Sterile Water for Injection.  Therefore is not suitable for parenteral applications. 16
  • 17. Water-miscible vehicles  A number of solvents that are miscible with water have been used as a portion of the vehicle in the formulation of parenterals.  These solvents are used to solubilize certain drugs in an aqueous vehicle and to reduce hydrolysis.  The most important solvents in this group are ethyl alcohol, liquid polyethylene glycol and propylene glycol.  Ethyl alcohol is used in the preparation of solutions of cardiac glycosides and the glycols in solutions of barbiturates, certain alkaloids, and certain antibiotics.  Such preparations are given intramuscularly.  There are limitations with the amount of these co-solvents that can be administered, due to toxicity concerns, greater potential for hemolysis, and potential for drug precipitation at the site of injection.  Formulation scientists needing to use one or more of these solvents must consult the literature and toxicologists to ascertain the maximum amount of co-solvents allowed for their particular product. 17
  • 18. Non-Aqueous Vehicles  The most important group of non-aqueous vehicles is the fixed oils.  The USP provides specifications for such vehicles, indicating that the fixed oils must be of vegetable origin so they will metabolize, will be liquid at room temperature, and will not become rancid readily.  The USP also specifies limits for the free fatty acid content, iodine value, and saponification value (oil heated with alkali to produce soap, i.e., alcohol plus acid salt).  The oils most commonly used are corn oil, cottonseed oil, peanut oil, and sesame oil.  Fixed oils are used as vehicles for certain hormone (e.g., progesterone, testosterone, deoxycorticosterone) and vitamin (e.g., Vitamin K, Vitamin E) preparations.  The label must state the name of the vehicle, so the user may beware in case of known sensitivity or other reactions to it. 18
  • 19. Antimicrobials  Added for fungistatic or bacteriostat action or concentration.  Used to prevent the multiplication of micro-organisms.  Examples:  Benzyl alcohol -- 0.5 – 10 %  Benzethonium chloride -- 0.01 %  Methyl paraben -- 0.01 – 0.18 %  Propyl paraben -- 0.005 – 0.035 %  Phenol -- 0.065 – 0.5 % 19 Preservatives  Multidose containers must have preservatives unless prohibited by monograph.  Large volume parenteral must not contain preservative b’coz it may be dangerous to human body if it contain in high doses.
  • 20. Antioxidants  Used to protect product from oxidation.  Acts as reducing agent or prevents oxidation. 20 A) Reducing agent:  Ascorbic acid -- 0.02 – 0.1 %  Sodium bisulphate -- 0.1 – 0.15 %  Sod. Metabisulphite -- 0.1 – 0.15 %  Thiourea -- 0.005 % C) Synergistic:  Ascorbic acid ,  Citric acid ,  Tartaric acid. B) Blocking agents:  Ascorbic acid esters -- 0.01 – 0.015%  BHT -- 0.005 – 0.02 % D) Chelating agent:  EDTA -- 0.01- 0.075 % Example
  • 21. Buffers  Added to maintain pH,  Change in pH may causes degradation of the products  Acetates, citrates, phosphates are generally used. Factors affecting selection of buffers:  Effective range,  Concentration  Chemical effect on the total product Examples:  Acetic acid, adipic acid, benzoic acid, citric acid, lactic acid  Used in the conc. of 0.1 to 5.0 % 21
  • 22. Stabilizers  As parenterals are available in solution form they are most prone to unstabilize.  Used to stabilize the formulation  Maintain stable Examples:  Creatinine – 0.5- 0.8 %  Glycerin – 1.5 – 2.25 %  Niacinamide – 1.25 -2.5 %  Sodium saccharin – 0.03 %  Sodium caprylate – 0.4 % 22
  • 23. Chelating agents  Used to form the complex with the metallic ions present in the formulation so that the ions will not interfere during mfg. of formulation.  They form a complex which gets dissolved in the solvents. Examples:  Disodium edetate – 0.00368 - 0.05 %  Disodium calcium edetate - 0.04 % 23
  • 24. Solubilizing agents  Used to increase solubility of slightly soluble drugs  They acts by any one of the following:  Solubilizers,  Emulsifiers or  Wetting agents. Examples:  Dimethylacetamide, Ethyl alcohol, Glycerine, Lecithin, PEG – 40 + Castor oil, PEG – 300, Polysorbate 20, 40, 80 24
  • 25. Inert gases  Another means of enhancing the product integrity of oxygen sensitive medicaments is by displacing the air the solution with nitrogen or argon.  This technique may be made more effective by first purging with nitrogen or boiling the water to reduce dissolved oxygen.  The container is also purged with nitrogen or argon before filling and may also be topped off with gas before sealing. 25
  • 26. Tonicity adjusting agents  Used to reduce the pain of injection.  Buffers may acts as tonicity contributor as well as stabilizers for the pH.  Isotonicity depends on permeability of a living semipermeable membrane  Hypotonic : swelling of cells (enlargement)  Hypertonic: shrinking of cells (reduction) Examples:  Glycerin, Lactose, Mannitol, Dextrose, Sodium chloride, Sorbitol 26
  • 27. Surfactants  Used:  to dispose a water-insoluble drug as a colloidal dispersion.  for wetting powder.  to prevent crystal growth in a suspension.  to provide acceptable syringability.  for Solubilizing steroids and fat-soluble vitamins.  Example:  Polyethylene 0.1 to 0.5%  Sorbitan monooleate 0.05 to 0.25% 27
  • 28. Protectants  Used to protect against loss of activity caused by some stress  Used to prevent loss of active ingredients by adsorption to process equipment or to primary packaging materials  Protectants primarily used in protein formulations. Examples:  Sucrose, glucose, lactose, maltose, trehalose (2 to 5%)  Human serum albumin (0.1 to 1%) 28