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A report about


Submitted to:
Prof. Aleli C. Baes MSPharm, RPh

GATDULA, Angelika
JULIAN, Ma. Cristine Michelle
OCAMPO, Samantha Leigh

March 18, 2016

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Title Page .



Introduction ...

Definition of Terms ..

Method/s of Preparation .

Machine/s used in Preparation .....

Pictures (Preparation, Machines/Equipment) ....

Packaging, Labelling and Storage ...

Special Considerations ...

Products of Biotechnology
Introduction .......

Definition of Terms ..

Method/s of Preparation .....

Machine/s used in Preparation ..


Pictures (Sample Biotechnology Products, Machine)...


Packaging, Labelling and Storage ...


Novel Dosage Forms and Drug Delivery Technologies

Introduction ......


Definition of Terms ..


Method/s of Preparation .


Machine/s used in Preparation..


Pictures (Preparation, Product Example Machines/Equipment)


Packaging, Labelling and Storage ..........


References .


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A radiopharmaceutical is a radioactive pharmaceutical agent that is used for
diagnostic and therapeutic procedures. A radiopharmaceutical consists of a drug
component and a radioactive compound. Most radionuclides contain a component that
emits gamma radiation. Systemic administration of radiopharmaceuticals for sitespecific use allows physician to treat widely disseminated diseases.
Nuclear medicine can detect the radiation coming from inside the patients body. All of
these other procedures expose the patients to radiation from outside the body using
machines that send radiation through the body. As a result, nuclear medicine
determines the cause of a medical problem based on organ function in contrast to the
other diagnostic tests, that determine the presence of disease based on anatomy or
structural appearance.
Radioactive Pharmaceuticals
a. Strontium-89 Chloride (89Sr) - It is a sterile, nonpyrogenic aqueous solution for
intravenous use and contains no preservative.
Indication: Painful skeletal metases
Dosage Form: Intraveneous Injection
Half life: 51 days
b. Sodium Iodide 123 (123I) - It is use for diagnostic imaging , it delivers lower
radiation doses and has better imaging properties. It is use diagnostically to
evaluate thyroid function and morphology.
Dosage form: Oral Capsule
Half life: 13 hours
Non-radioactive Pharmaceuticals
a. Captopril - It is used to help diagnose renovascular hypertension in
hypertensive patients with abnormal bruits, declining renal function and poorly
controlled hypertension with drug therapy.
b. Adenosine - This drug can increase coronary blood flow four to five times that
of rest and can be beneficial as a pharmaceutical stress agent to help diagnose
and identify stenosed arteries.

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Definition of Terms
Diagnostic - concerned with the diagnosis of illness or other problems
Elution - The act of obtaining a radiopharmaceutical from a solid column generator.
Gamma rays - are used to kill cancer cells, to sterilise medical equipment and in
radioactive tracers alpha particles in smoke detectors
Half life - Describes the time required for a drugs blood or plasma concentration to
decrease by half.
Radiopharmaceuticals - a radioactive pharmaceutical agent that is used for diagnostic
and therapeutic procedures.
Radionuclides - substances that have varying numbers of protons and neutrons as
compared to stable elements
Radiation Dose - The amount of radiation absorbed by body tissue in which a
radioactive substance
Therapeutic - the branch of medicine concerned with the treatment of disease and the
action of remedial agents.

Methods of preparations
The preparation of radiopharmaceutical is confounded by issues of radioactivity
and chemical reactions. Compounding of a radiopharmaceutical involves chemical
reactions to label a molecule with a radionuclide. Manufacturers produce a ready to use
radiopharmaceuticals and radio nuclides used in compounding radiopharmaceuticals at
the nuclear pharmacy.
Elution- this process is related to the act of obtaining a radiopharmaceutical from
a solid column generator.

Machine used in Preparation

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Radionuclide Generator
Machine / Equipment

Position Emission Tomography Scan

A positron emission tomography (PET) scan is a type of imaging test. It uses a

radioactive substance called a tracer to look for disease in the body. A PET scan uses a
small amount of radioactive material. The tracer is given through a vein.

Radioactive Pharmaceuticals

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Strontium-89 Chloride

Sodium Iodide 123

Gallium 67

Non- Radioactive Pharmaceuticals





Radiopharmaceuticals should be kept in well-closed containers and stored in an
area assigned for the purpose. The storage conditions should be such that the
maximum radiation dose rate to which persons may be exposed is reduced to an
acceptable level. Care should be taken to comply with national regulations for protection
against ionizing radiation.
Radiopharmaceutical preparations that are intended for parenteral use should be
kept in a glass vial, ampoule or syringe that is sufficiently transparent to permit the

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visual inspection of the contents. Glass containers may darken under the effect of

Special considerations
the dispensing pharmacist must ensure that the ordered dose is safe for the patient
the pharmacist must weigh and consider the patient factors such as weight, age,
surface area and gamma camera sensitivity with each order.
radiopharmaceuticals are to be compounded using appropriately shielded vials and
syringes in a properly functioning and certified ISO class 5, primary engineering control
room located in an ISO class 8 or cleaner air environment to permit compliance with
special handling, shielding and negative air flow requirements.
breast feeding should be noted in the patient history from the attending physician
breast feeding should be interrupted for the period during which radioactivity is known
to appear in the breast milk.

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Products of Biotechnology
The term biotechnology encompasses any technique that uses living organisms
(e.g., microorganisms) in the production or modification of products. The classic
example of biotechnologic drugs was proteins obtained from recombinant DNA (rDNA)
technology. rDNA and monoclonal antibody (MAb) technologies have provided exciting
opportunities for the development of more pharmaceuticals and approaches to the
diagnosis, treatment, and prevention of disease.
The ultimate goal of pharmacogenomics is to define the contributions of inherited
differences in drug disposition and / or targets to drug response and thereby improve
safety and effectiveness of medications through genetically guided individualized
As the use of novel technologies is incorporated into the routine clinical practice,
opportunities to make pharmaceutical care even more personalized. The goal of
biotechnology products is to create oral administered products to supplant injection or
infusion administration.

Definition of Terms
Biotechnologic Products are develop through the use of living systems and
Chelating Agents are chemical compounds (usually organic compounds) that form
complexes with metal ions or other substrates.
DNA Probes - a hybridization probe is a fragment of DNA or RNA of variable length
(usually 100-1000 bases long) which can be radioactively labeled. Detect the presence
of nucleotide sequences (the DNA target) that are complementary to the sequence in
the probe.
Epitope also known as antigenic determinant is the part of an antigen that is
recognized by the immune system, specifically by antibodies, B cells, or T cells.
Exogenous - produced by growth from superficial tissue.

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Novel- new and different from what has been known before.
Phagocytes a type of cell within the body capable of engulfing and absorbing bacteria
and other small cells and particles.
Pharmacogenomics - is the application of genomic technology to genetic variation in
response to pharmaceutical compounds.
Sorption is the common term used for both absorption and adsorption. These terms
are often confused. Absorption is the incorporation of a substance in one state into
another of a different state.
Tonicity - is a measure of the effective osmotic pressure gradient (as defined by the
water potential of the two solutions) of two solutions separated by a semipermeable

Methods of Preparation

The products do not contain preservatives. Because it is recommended that only

one dose will be prepared in each vial.
Two special considerations in preparing biotechnologic products:

A. The use of filters it can result in some loss of the drug available to the patient.
B. Sorption of drugs to containers can result in drug loss.

a. Production of Biotechnology Products

Recombinant DNA - DNA probe technology is being used to diagnose disease. It

uses small pieces of DNA to search a cell for viral infection or for genetic defects.
DNA probes have application in testing for infectious disease, cancer, genetic
defects and susceptibility to disease.

Monoclonal Antibodies - Antibodies are proteins produced by the B

lymphocytes of the immune system in response to foreign proteins,
called antigens. Antibodies function as markers, binding to the antigen so that the
antigen molecules can be recognized and destroyed by phagocytes. The part of the
antigen that the antibody binds to is called the epitope. The epitope is thus a short
amino acid sequence that the antibody is able to recognize.

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Polymerase Chain Reaction - is a biotechnology process whereby there is

substantial amplification of target nucleic acid sequence. The three-step process
involves DNA to separate into two strands, a nucleic acid primer is hybridized to
each DNA strand and a DNA polymerase enzyme is added for extension of the
primer along the DNA strand to copy the target nucleic acid sequence.

Gene Therapy - is a process in which exogenous genetic material is transferred into

somatic cells to correct an inherited or acquired gene defect. Also, it is intended to
introduce a new function or property into cells.

Nucleotide Blockade / Antisense - Nucleotide blockade and antisense technology

focuses on the study of function of specific proteins and intracellular expression.

Peptide Technology it entails screening for polypeptide molecules that can mimic
larger proteins. This is intended to afford relatively simple products that can be
stable and easy to produce.
b. Formulation
Most biotechnology products are made from PROTEINS.
Product = active drugs constituent + total drug delivery system
Stabilizers such as surfactants, amino acids, polyhydric alcohols, fatty acids,
proteins, antioxidants, reducing agents and metal ions.
pH is also one of the key factors in developing a stable product.
Chelating agents can be incorporated to bind trace metals.
Antioxidants are often incorporated because oxidation is one of the major
factors in protein degradation.
Preservatives may be necessary like phenol, chlorobutanol and benzyl
Polypols are good stabilizers.
Tonicity-adjusting agents include sodium chloride and dextrose in
concentrations necessary to achieve isotonicity with 0.9% NaCl solution

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Machine Used in Preparation


XDM Quad Propylene Mixing System

Pictures (Sample of Biotechnology Products)

Hepatitis B Vaccine
Recombinant (Engerix-B)

Interferon Beta 1-b

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Basiliximab (Simulect)

Packaging and Storage

Biological products should be kept under refrigeration at 35 to 45 F. (2 to 7 C.)
unless the inherent nature of the product makes storage at a different temperature
Granulocyte Colony-Stimulating Factor (Filgrastim) is supplied in boxes
containing 10 glass vials and it should be stored at 2C to 8C.
Epoetin Alfa Each vial contains human albumin of 2.5 mg to prevent absorptive
losses and it should be refrigerated at 2C to 8C.
Fusion Inhibitors: Enfuvirtide (Fuzeon) The dosage of enfuvirtide is 90 mg (1-mL
sterile water for injection) subcutaneously twice daily into the upper arm, anterior high,
or abdomen.
Anakinra (Kineret) is packaged in single-use prefilled syringes with recommended
dosage in 100 mg per day subcutaneously.
Oprelvekin (Neumega) produced from E. coli by rDNA technology. It is supplied as 5
mg of lyophilized powder in a single-use vial.
Adalimumab (Humira) is administered subcutaneously as an easy-to-use, singleuse, prefilled syringe or disposable, single-use pens for subcutaneous injection (40mg /

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Changes are coming about as new technologies are developed and reduce the
limitations of existing therapies. New drugs require new delivery systems because the
traditional systems are inefficient or ineffective. This may be true especially of some of
the recombinant DNA and gene therapies of the future. Soon, there will be manipulation
of genes as active drugs and as drug delivery systems and even work in technology.
New drug delivery system development is largest based on promoting the
therapeutic effects of a drug and minimizing the toxic effects by increasing the amount
and persistence if a drug in the vicinity of a target cell and reducing the drug exposure
of nontarget cells. Therapeutic efficacy of selected products can be enhanced and in
some cases the toxicity can be decreased by incorporating novel polymer technology.

Definition of Terms
Drug- subs used in medicine
Implant - to place in a persons body by means of surgery
Intrauterine - used or occuring within the uterus
Iontophoresis - introduction of a ionized subs through intact skin by the application of a
direct electric current.
Opthalmic - route of administration characterized by application of a sterile preparation
to the external parts of the eye.
Oral- relating to the mouth.
Parenteral - occurring outside the intestine.
Physicochemical - relating to chemistry that deals with the physicochemical properties
of subs.
Topical - made to be put on the kin
Vaginal- relating to/ affecting the genital vagina

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Viscosity - property of resistance to flow in a liquid or semi fluid

Machine Used in Preparation

DuPeliontophoresis system

Phoresor II iontophoresis system

Pictures (Sample of Biotechnology Products)

Diagram of an osmotic pump


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Packaging and Storage

OsmoticPump a stainless steel or polyethylene tube or catheter is inserted into the
inner chamber from which the drug is channelled.
Estring the core of the ring contains reservoir of estradiol, which is released
immediately and then at a continuous rate of 75 mg per 24 hours over 90 days.
Intrauterine Progesterone Drug Delivery System slowly releases an average of 60
ug of progesterone per day for 1 year after insertion.
Dinoprostone Vaginal insert - the unit contains 10 mg of dinoprostone in 236 mg of a
cross linked polyethylene oxide-urethane polymer slab that measures 29 mm by 9.5 mm
and is 0.8 mm thick.
Crinone Gel the polymer, which is insoluble in water, swells within the vagina and
forms a bioadhesive gel coating on the walls of the vagina.
Pilocarpine Insert the release rate of pilocarpine is in the range of 20 or 40 mg per
hour for 4 to 7 days.
Giladel Wafer Implant each wafer contains 192.3 mg of a biodegradable
polyanhydride copolymer and 7.7 mg of carmustine.

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Allen, L. Jr., Ansel, H. (2014). Ansels Pharmaceutical Dosage Forms and Drug Delivery
Systems. 10th Edition. pp. 638 750.
Retrieved on March 14, 2016.
Images retrieved from