ophthalmic. biologics. dialysis. injections and pellets.

1. STERILE PRODUCTS
STEFANIE CAMBRI

2. OBJECTIVES:
A. TO KNOW THE DIFFERENT PREPARATIONS UNDER STERILE
PRODUCTS
B. OPTHALMIC PREPARATIONS
TYPES. REQUIREMENTS. FORMULATION. PACKAGING
C. BIOLOGICS
CATEGORIES & PROPERTIES. IG CLASSES. EFFECTIVES. TYPES.
DOSAGE FORM AND STRENGTH

3. OBJECTIVES:
D. DIALYSIS
TYPES. FUNCTIONS. ADVANTAGES & DISADVANTAGES
E. INJECTION
TYPES AND ROUTE OF ADMNISTRATION
F. PELLETS
TYPES & METHODS

4. STERILE PRODUCTS
Products that are going to be
administered using enteral route of
administration. The product are going
to be infused directly into the blood
stream or body tissue. It is extremely
important that they be “sterile” and
“pyrogen free”

5. DIFFERENT PREPARATIONS
UNDER STERILE PRODUCTS:
Ophthalmic Products
Biologics
Dialysis
Injections and
Pellets

6. OPHTHALMIC
PRODUCTS

7. Introduction
Ophthalmic dosages are preparations designed for
application to the eye:
for the treatment of disease
for symptomatic release of symptoms
for diagnostic purpose
as aid surgical procedures

8. Introduction
Ophthalmic dosages are preparations designed for
application to the eye:
for the treatment of disease
for symptomatic release of symptoms
for diagnostic purpose
as aid surgical procedures

9. Introduction
• Ophthalmic products are the sterile products
meant to installation in to the eye in the space
between eye lid and the eye ball.

10. Ophthalmic products
include:
Eye Drops
Eye Lotion
Eye Ointment
Eye Suspension
Contact Lens Solution

11. Eye Drops
Eye drops are sterile aqueous
or suspensions of drug that are
instilled into the eye with the
dropper. They usually contain
drugs having antiseptic, anti
anesthetic, anti inflammatory,
mydriatic or meiotic properties.

12. Eye Lotion
Eye lotion are the aqueous
solution for washing the eye.
The eye lotions are supplied in
concentrated form and are
required to be diluted with
warm water immediately
before use.

13. Eye Ointment
Are sterile preparations meant
for application to the eye.
These are prepared under
aseptic conditions and packed
in sterile collapsible tubes
which keep the preparation
sterile until whole of it is
consumed.

14. Eye Suspension
Are not commonly used as
compared to eye drops. They
are prepared only in those
cases, when the drug is
insoluble in the desired vehicle
or unstable liquid form.

15. Contact lens solution
are usually made from
“polymethyl-methacrylate” a
hard hydrophobic plastic, nut
some softer hydrophilic lenses
have been developed and are
coming to use.

16. Types of ophthalmic products
Ophthalmic products may be categorized into a
number of groups:
Liquid preparations for application to the surface
of the eye such as eye drops and eye lotions.
Semi solid preparations such as eye ointments,
creams, and gels for application to the margin eye
lid or for introduction in to the conjuctival sac.

17. Types of ophthalmic products
Solid preparations such as ocular inserts
intended to be placed in contact with the
surface of the eye to produce modified release
of medicament over a prolonged period.
Parenteral products for sub conjuctival or intra
ocular injection
Liquid products for irrigation of the eye during
surgical procedures

18. REQUIREMENTS
Ophthalmic preparations should posses
the following properties:
Foreign particles
Viscosity
Tonicity
pH of preparation
Sterility
Surface activity

19. Foreign Particles
All the ophthalmic products should be clear and free
from foreign particles, fibers and filaments.
Ophthalmic solutions should be clarified very carefully
by passing through bacteria proof filters such as
membrane filters, sintered glass filters.

20. Foreign Particles
The particle size of the eye suspension should be in
an ultrafine state of subdivision to minimize irritation.
A separate filter should be used for different
ophthalmic products in order to avoid the
contamination.

21. VISCOSITY
The particle size of the eye suspension should
be in an ultrafine state of subdivision to
minimize irritation.
In order to prolong the contact time of the
drug in the eye, various thickening agents are
added in the ophthalmic preparations.

22. VISCOSITY
An ideal thickening agent should posses the
following properties:
it should be easy to filter
it should be easy to sterilize
it should be compatible with other ingredients
it should posses requisite refractive index and clarity
level.

23. TONICITY
Ophthalmic product should be isotonic with
lachrymal secretions to avoid discomfort and
irritation.
 It has been observed that eye can tolerate a
range of tonicity 0.5-2% NaCl. There are certain
isotonic vehicles which are used to prepare
ophthalmic products like 1.9% boric acid, sodium
acid phosphate buffer.

24. pH of Preparations
pH plays an important role in therapeutic activity,
solubility, stability, and comfort to the patient.
 Tears have a pH of about 7.4 eye can tolerate
solution having wide range of pH provided they
are not strongly buffered, since the tear will
rapidly restore the normal pH of the eye.

25. Sterility
Ophthalmic preparations must be
sterile when prepared.

26. Sterility
Pseudomonas aeroginosa is very
common gram negative bacteria which
are generally found to be present in
ophthalmic products. It may cause serious
infections of cornea. It can cause
complete loss of eye sight in 24-48 hours.

27. Sterility
To maintain sterility in multi dose container,
containing ophthalmic products, a suitable
preservative is added. The preservative should
be non-toxic, non-irritant and should be
compatible in medicaments.

28. Sterility
The ophthalmic products are generally
sterilized by autoclaving, filtration through
bacteria proof filters and addition of
bactericides at low temperature.

29. Surface Activity
Vehicles used in ophthalmic preparations must
have good wetting ability to penetrate the
cornea and other tissues. Certain surfactants
or wetting agents added which are found
suitable for ophthalmic products. It should
not cause any damage to the tissue of eye.

30. FORMULATION
Drug
Preservative
Sterilization
Isotonicity
Buffer
Viscosity
Container
Label

31. FORMULATION
Drug
these contain drug of various
categories including antiseptic, anti
inflammatory agent, mydriatic or
meiotic properties.

32. FORMULATION
Preservative
eye drop should be sterile and
should contain preservatives to
avoid microbial contamination
when the container is open.

33. FORMULATION
Sterilization
eye drops are sterilized by
autoclaving at 121 degree Celsius
for 15 minutes or by bacteria filter
to avoid thermal degradation.

34. FORMULATION
Isotonicity
all the solutes including drug
contribute to the osmotic pressure of
the eye drop, therefore isotonicity of
the formula should be calculated and
adjusted with sodium chloride.

35. FORMULATION
Buffer
the buffer should be added to
maintain balance between
comfort, solubility, stability, and
activity of drug.

36. FORMULATION
Viscosity
the size of drops and its
residences in eye depends
on viscosity of eye drops.

37. FORMULATION
Container
the commonly used container
for ophthalmic solutions or
suspension is multi-dose
container
(5ml, 10ml).

38. FORMULATION
Label
not for injection. For external
use only. Shake well before
use.

39. Packaging
Eye drops have been packaged almost entirely in plastic
dropper bottles.
The cap is made of harder resin than the bottle.
The glass bottle is made sterile by dry-heat or steam
autoclave sterilization.
Amber glass is used for light resistance.

40. BIOLOGICS

41. Biologics…
a preparation, such as a drug a vaccine, or an
antitoxin, that is synthesized from living
organisms or their products and used as a
diagnostic, preventive, or therapeutic agent.

42. 2 Categories of Biologics
1st category
- ANTIGEN
a toxin or other foreign substances that induces an
immune response in the body, especially the production
of antibodies.

43. 3 categories of Antigens:
1. Biologically – an antigen is a substance that when
introduced into the tissue of human or other vertebrates
that causes formation of antibodies.
“2 Biologic Properties”
a. Immunogenicity - capacity to induce antibody formation
b. Specificity - governed by small chemical sites on the
antigen molecule called antigenic determinants.

44. 3 categories of Antigens:
2. Chemically - antigens are usually
protein, however, some high molecular
weight polysaccharides are antigenic.

45. 3 categories of Antigens:
3. Physically - antigens must
possess high molecular weight. A
weight more than 10,000 daltons is
required.

46. 2 Categories of Biologics
2ND category
- ANTIBODIES
specialized cells of the immune system which can be
recognize organisms that invade the body ( such as bacteria,
viruses, and fungi). The antibodies are then able to set off a
complex chain of events designed to kill these foreign
providers.

47. Immunoglobulin Classes:
IgA (alpha heavy chains)
IgD (Delta heavy chains)
IgE (Epsilon heavy chains)
Igm (Mu heavy chains)
IgG (Gamma heavy chains)

48. IMMUNITY
is the state of having sufficient biological
defenses to avoid infection, disease, or other
unwanted biological invasion. It is the capable
of the body to resist harmful microbes from
entering it.

49. IMMUNITY
Natural immunity- is the natural resistances with
which a person is born
Acquired Immunity- immunity obtained either
from the development of antibodies in response to
exposure to an antigen, as from vaccination or an attack
of an infectious disease, or from the transmission of
antibodies, as from month to fetus through the
placenta or the injection of anti serum

50. Acquired Immunity
1. Active Immunity
a. Naturally acquired active immunity- receive by the
body in a natural manner
b. Receive by the body through the administration of
a vaccine or toxoid.

51. Acquired Immunity
2. Passive Immunity – is the transfer of active immunity, in
the form of readymade antibodies, from one individual to another
a. Artificially acquired passive immunity- a short-term
immunization by the injection of antibodies, such as gamma
globulin, that are not produced by the recipient’s cells
b. Naturally acquired passive immunity- occurs during
pregnancy, in which certain antibodies are passed from the
maternal into the fetal bloodstream.

52. Vaccine
a substance used to stimulate the
production of antibodies and provide
immunity against one or several diseases ,
prepared from the causative agent of a
disease, its product or a synthesis
substitute, treated to act as an antigen
without inducing the disease.

53. Vaccine
Vaccines create the immunity that protects
you from the an infection sometimes
vaccines are called immunization, needled,
or shots. They boost your body’s own
defense system which is called the immune
system.

54. Vaccine Type
Small pox Vaccine
Rabies Vaccine
Influenza Vaccine
Poliomyelitis Vaccine
Measles Vaccine
Mumps Vaccine
Hepatitis Vaccine
Rickettsial Vaccine
Bacterial Vaccine
Typhoid Vaccine
Cholera Vaccine
Plauge Vaccine
Pertussive Vaccine
Pneumococcal Vaccine
Polio Virus Vaccine Live Oral

55. Small Pox Vaccine
is the living virus vaccinla(cowpox) that has
been grown in the skin of a vaccinated bovine
calf. It was the first vaccine for small pox
invented by Edward Jenner to treat small pox
disease caused by Variola major and Variola
minor viruses.

56. Small Pox Vaccine
Who should get small pox vaccine?
1. Anyone who is allergic to the vaccine or any of its component
(streptomycin, chlortetracycline, neomycin)
2. Pregnant women
3. Lactating women
4.Persons with skin problems (i.e eczema and atopic dermatitis)
5. People with weakened immune system such as those with
received transplant.
6. HIV positive

57. Small Pox Vaccine
Side Effects of small pox vaccine
I. Feeling usually cold
II. Shivering
III. Swollen painful of lymph glands in the neck, armpit, or groin
Dose:
It is administered by making punctures in the skin with special needle.
Re – vaccination is recommended at least every 10 years.

58. Rabies Vaccine
it is also known as human diploid
cells rabies vaccine (HDCV)

59. Rabies Vaccine
The pre exposure schedule for rabies
vaccine in 3 doses given the ff. time:
Dose 1 – As appropriate
Dose 2-7 – Days after 1 dose
Dose 3-7 – Days or 28 days after 1 dose

60. Influenza Vaccine
a sterile aqueous suspension inactive
influenza virus type A and B. It is also
contains a suitable preservative and
may contain an adsorbent such as
aluminum phosphate or protamine.

61. Influenza Vaccine
2 types of influenza Vaccine:
1. The injection (with killer virus)
2. Nasal spray Vaccine ( containing live
but weakened virus)

62. Influenza Vaccine
How long is flu vaccination good for?
- The flu vaccination will protect you for only one flu
season
Does the vaccine work right away?
- It takes two weeks after the vaccination for antibodies to
develop in the body and provide protection against virus
infection.

63. Poliomyelitis Vaccine
is an active immunizing agent used to
prevent polio. It work by causing your body
to produce its own protection ( antibodies)
against the virus that causes polio.

64. Poliomyelitis Vaccine
“Polio” is a very serious infection that
causes paralysis of the muscles that
enable you to walk and breathe.

65. Poliomyelitis Vaccine
Immunization against polio is recommended
for:
1. All infants from 6 to 7 weeks of age.
2. All children.
3. All adolescence 18 years old of age
4. Adults who are greater risk of exposure to polio
virus.

66. Poliomyelitis Vaccine
3 types of Polio Virus
Type 1 (Brunhilde) – most often isolated from
paralytic cases
Type 2 (Lansing) – concerned in sporadic
disease
Type 3 (Leon) – proved to be etiologic agent in
less frequent epidemics

67. Polio Virus Vaccine Live Oral
Oral polio vaccine was developed by Albert
Sabin.
It is also called “trivalent oral polio vaccine”
or “sabin vaccine”
Doses: 2 doses not less than 8 weeks
intervals

68. Measles Vaccine
a highly effective vaccine used against measles that
contain live attenuated rubella (german measles)
virus. The vaccine acts by stimulating the adaptive
immune response and provides long term protection
against the disease.
Stored in temperature of between 2 and 8 degrree
and have 1 year expiration.

69. Mumps Vaccine
prepared with the B- level Jeryl Lynn Strain from
the virus which is growth in cell cultures of
chicken embryo tissue and provides active
immunity for at least 10 years after
immunization and its particular valuable to
susceptible individuals approaching puberty and
to adults

70. Hepatitis Vaccine
the vaccine contains one of the viral envelope
proteins, hepatitis B surface antigen. It is produced by
yeast cells, into which the genetic code for HBsAg has
been inserted. Atlease 2 to 3 vaccine injections is
given, the second injection at least one month after
the first dose and the third injection being
administered six months after the first dose.

71. Rickettsial Vaccine
cultured in chicken embryo or in monkey kidney
tissue cultures in a manner similar to that for
viruses. They cannot be grown in artificial
culture media and must be subjected to the
same precautions as viruses.

72. Bacterial Vaccine
a preparation of killed or attenuated
bacteria used as an active immunizing
agent.

73. Typhoid Vaccine
any of several preparations of Salmonella typhi
used for immunization against typhoid fever.
Recommended for persons who have
household contact with known typhoid carrier or
for travelers going to areas of the world where
typhoid fever is endemic

74. Cholera Vaccine
a sterile suspension of killed cholera vibrios
(vibrio cholera) in isotonic sodium chloride
solution or other suitable diluents

75. Plague Vaccine
a preparation of killed Yersinia pestis bacilli,
administered intramuscularly as an active
immunizing agents against plague

76. Pertussive Vaccine
a preparation of killed Bordetella pertussis
bacilli or purified antigenic components thereof,
used to immunize against pertussis; generally
used in combination with diphtheria and tetanus
toxoids

77. Pneumococcal Vaccine
causing the majority of pneumococcal disease;
used as an active immunizing agent in persons
over 2 years of age, administered
intramuscularly

78. DIALYSIS

79. Dialysis
a method of removing toxic substances
( impurities or wastes) from the blood
when the kidney are unable to do so.

80. Dialysis
most frequently used for patients who have
kidney failure, but may also be used to
quickly remove drugs or poisons in acute
situation. This techniques can be life saving
in people with acute or chronic kidney
failure.

81. Type of Dialysis
Hemodialysis- requires a machine to
transport the blood and dialyzing fluid on
either side of semi-permeable membrane to
effect the removal of toxic metabolites and
excess water.

82. Functions:
cleanses the blood of accumulated waste
products
removes the by- products of protein metabolism(
urea, creatinine and uric acid)
removes excessive fluids
maintains or restores the buffer system of the
body
maintain or restores electrolyte levels

83. Access:
Subclavian and femoral catheter- may be
inserted for short term or temporary use in
acute renal function. May be left in place for
up to 6 weeks if complications do not occur.

84. Access:
External arteriovenous shunt- formed by
surgical insertion of 2 silastic cannulas into
an artery or vein in forearm or leg to form an
external blood path

85. ADVANTAGES:
can be used immediately after insertion
no venipuncture necessary for dialysis
less danger of clotting and bleeding
can be used indefinitely
decreased incidence of infection
no external dressing required

86. DISADVANTAGES:
external danger of disconnecting or dislodging
the shunt
risk of hemorrhage, infection or clotting
skin erosion around the catheter site
Internal arteriovenous fistula- for chronic dialysis
clients. Created surgically by anastomosis of a
large artery and large vein the arm

87. DISADVANTAGES:
cannot be used immediately after insertion
venipuncture is required for dialysis
infiltration of needle- hematoma
aneurysm in the fistula
arterial steal syndrome
Internal arteriovenous graft- for chronic dialysis clients who do not
have adequate blood vessels for the creation of a fistula. Can be used
2 weeks after insertion.
Complication: clotting, aneurysm and infection

88. INJECTIONS

89. What is an injection?
Injections are sterile solutions, emulsions or
suspensions. They are prepared by
dissolving, emulsifying or suspending an
active ingredient and any other substances in
water for injection.

90. What is an injection?
Injecting the act of giving medication by use
of syringe and needle to obtain the desired
therapeutic effect taking into account the
patients safety and comfort.

91. How does drug for injection
presented?
1. Single dose preparation- prepared volume of measured
drug, in a syringe for single dose use
i.e Flu vaccines, pneumovax and B12.

92. How does drug for injection
presented?
2. Multiple dose preparation- multi dose preparations contain
a antimicrobial preservative, are used on more than the one
occasion and great care is required for its administration but
especially it’s storage between successive withdrawals
i.e Insulin

93. Why give drugs in an injection
form?
Injections usually allow rapid absorption
Can produce blood levels comparable to those
of intravenous bolus injection
Drugs that are altered or not absorbed by other
methods of administration

94. Routes of Administration
Subcutaneous (SC)- into tissue below dermis
of skin
Intramuscular (IM)- into the body muscle
Intravenous (IV)- into a vein
Intradermal- into the dermis just under the
epidermis

95. Intradermal Injections
Most often used for PPD
Site: the inner aspect of the forearm
Needle size is 25-27 gauge, ½ to 5/8 inch
Insert needle at 15 degree angle
Injection made just below the outer layer of skin

96. Intradermal Injections
If injection does not form a wheal or if bleeding is
noted, the injection was probably too deep and
should be repeated.
Review the provider’s order for accuracy
Ask the patient/parent if the patient is allergic to the
medication
Select proper needle size, length and gauge

97. Intradermal Injections
Explain procedure to the patient
Ask for assistance with children
Position patient appropriately
Prepare injection site with alcohol- air dry
Support skin with thumb
With bevel up, completely insert bevel at a15 degree
angel

98. Intradermal Injections
Inject medication gently, place a cotton ball over the
site after needle removal
A visual wheal will be produced at the site
Dispose of needle as per policy
Wash Hands
Document procedure and patient’s response

99. Subcutaneous Injections
Administration:
Subcutaneous injection
Rotate site
Check blood sugars regularly

100. Subcutaneous Injections
Storage:
Refrigerate until use
Once the vial is punctured, it is good for
28 days and can be left at room
temperature

101. Subcutaneous Injections
Dosing:
 starting daily dose: 0.5-1 unit/kg/day in divided doses
 Adjust according to fasting (premeal) blood glucose of 80-130
mg/dL and peak postprandial blood glucose < 180 mg/dl
 Provide 50% as long acting insulin and 50% as prandial insulin
 1 unit of an account for 30 grams of carbohydrates(14-50)
 1 unit can lower 50 mg/dL blood glucose (10-100)

102. Subcutaneous Injections
Contraindications
Severe hypoglycemia
Allergy or sensitivity to any ingredients
of the product

103. Intramuscular Injections
Factors that can cause pain are:
 The needle
 The technique
 The speed of the injection
 The solution and comparison of the drug
 the volume of the drug
 The approach and attitude of person administering the
injection

104. Intravenous Injections
injecting in the vein is considerably more
dangerous than other types of injection, the
said proper technique can be at least
minimize the possible damage.

105. Intravenous Injections
Tourniquet:
 To get the veins to rise to a level at which you can hit
you will need a tourniquet.
 It is important to choose a gentle tourniquet, as something
too tight or hard could damage your delicate veins
 When trying the tourniquet, tuck it in upon itself or use a
self tightening loop. You want the technique to be slip off.

106. The 7 Right’s of Drug
AdministrationRight client
Right medication
Right dose
Right route
Right time
Right reason
Right documentation

107. Needle length and size
When choosing the needle it is important to
assess the amount of muscle, subcutaneous fat
and weight of the patient-which in the majority
of cases will be blue needle

108. Syringes
3 main parts:
 Barrel -chamber that holds the medication
 Plunger- part within the barrel that moves back and forth to
withdraw and instill medication
 Tip- part that the needle is attached to
Calibration:
 Syringes sizes from 1ml to 50ml
 Measure to a 1/10th or 1/100th depending on calibration

109. Needle
 Shaft of the needle
 length chosen depends on the depth o which medication
will be instilled
 Tip of shaft id beveled or slanted to pierce the skin more
easily
 Gauge: width of the needle (18-27 gauge)- a smaller
number indicates a larger diameter and larger lumen inside
the needle

110. Considerations when choosing
a syringe and a needle
Type of medication
Depth of tissue penetration required
Volume of medication
Viscosity of medication
Size of the client

111. Basic injection techniques
 Tell patient what to expect
 Do not drill
 Anchor heel of your hand on patients hip, leg, arm so you
can move with patient
 Do not recap used needle
 Ampule
use an alcohol pad to open
Use a filter needle
No air into ampule

112. PELLETS

113. Pellets
A small, sterile tablet used by implantation when
prolonged and continuous absorption is desired.
Ranges between (0.5-1.5mm)

114. Types of Pellets
1. Implants (pellets) Ex. Contraceptives
2. Orally Multiple-Unit Pellet System
(MUPS) Ex. PPIs
are kind of multi particulate system that has
become an important and successful dosage
form for immediate or modified drug release.

115. Methods of Preparation
1. Agitation ( balling)
 it is known as spherical agglomeration. In
this method, particles are converted to
spherical pellets by continuous rolling or
tumbling blender using a rotating drum or
pan.

116. Methods of Preparation
2. Drug layering
layering involves the deposition of
successive layers of dry powder or liquid
droplets of drug and binding into inert seed.

117. Methods of Preparation
3. Globulation
Spray drying- a drug solution or suspension is
sprayed, with or without excipients, into a hot air
stream, generating dry and highly spherical
particles.
Spray Congealing- also called spray-chilling, a
technique similar to spray- drying but no source
of heat is required.

118. Methods of Preparation
4. Compact (compression)
in this process mixtures of active ingredients and
excipients are compacted under pressure under
pressure to generate pellets of defined shape and size.
During compression at high pressure, particles of a
packed mass are forced against each other so that
elastic and plastic deformation can take place and
create strong inter particle contact.

119. Methods of Preparation
5. Compact ( Extrusion-spheronization)
in this process the powder is formed into a wet
mass, which is forced through restricted area
(extrusion) to form strands of extrudate that are
broken into short lengths and rounded by
placement on a rotating plate with an a cylinder.

120. Methods of Preparation
6. Cryopelletization
a process whereby droplets of a liquid
formulation are converted into spherical
pellet by using liquid nitrogen as fixing at
160° medium

121. Thank You for
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