Parenteral Products By: Howida Kamal, Ph.D
Dosage forms Route of administration Enteral INTO Parenteral ONTO Topical
Dosage forms Physical form Solid Liquid Semi-solid Powder Granules Tablets Capsules Suppository Pessary Inserts Sponges Microparticles Nanoparticles Liposomes Films Solution Suspension Emulsion Microemulsion Nanoemulsion Nanosuspension In-situ gels Cream Ointment Paste Gel
Dosage forms Sterility Sterile Free from all forms of microbial life (vegetative & sporing) Free from pathogens Non-sterile Extent of total bioburden Injections (parentrals) Ophthalmic Products
Sterile Products Parenteral Products Ophthalmic Products "para enteron = to avoid the intestines The 1 st Official injection in PB: morphine, 1867. The second cocaine was added 1898 after sterilization was attempted.
1. Sterility Parenteral Products Parenteral Products must meet a number of special criteria such as: 2. Pyrogen free 3. Free from foreign particles 4. Buffered ph Buffer capacity 5. Osmotic pressure (Isotonic, hypotonic, hypertonic) 6. Packaging Product protection Ease of use
Routes of Parenteral Administration Primary Specialized Intravenous (I.V.) Intramuscular (I.M.) Subcutaneous (s.c.) Made into a vein (introduced directly into the blood stream) Made into the striated muscle fibers that lie beneath the subcutaneous layer Made under the skin, into the subcutaneous tissue
Routes of Parenteral Administration Intravenous (I.V.) Intramuscular (I.M.) Subcutaneous (s.c.)
Intravenous injections Injected or infused directly into a vein.
Intravenous injections Site of injection Peripheral line Central line Peripheral veins Hand veins Arm veins Deep central veins Chest veins Neck veins Leg veins Femoral veins Dorsal foot veins Scalp veins (In small children )
Intravenous injections Method of injection Peripheral line Central line Plastic indwelling catheters (PVC, Teflon or polyethylene) Small volume injections 1.5 in length 22 gauge needle Intravenous infusion 1-2-in. long, beveled 18-22 gauge needle Smaller gauge numbers indicate larger outer diameters
Intravenous injections Method of injection -Thoroughly clean the skin-insertion site using alcohol swab for 30 seconds and then allowed to dry -Prepare the injection aseptically. -Aspirate before injection to ensure that the drug will be administered intravenously.
Intravenous injections Drug form Solution Emulsion (O/W) aqueous hydroalcoholic Volume 1 to >1000 ml Small volume Large volume
Intravenous injections Indications a. To achieve an immediate pharmacologic effect, especially in emergencies, such as arrythmias or seizures. b. To treat serious, life-threatening infections c. To guarantee delivery and distribution when hypotension or shock exists. d. To restore rapidly electrolyte and fluid balance. e. To provide continuous nutrition (hyperalimentation) when patients are unable to be fed by mouth. f. To administer drugs which would be too irritating or caustic to be given by other parenteral routes (due to the rapid dilution in the circulating blood and the general insensitivity of the venous wall to pain).
Intravenous injections Precautions (complications) a. Uncontrolled or excessive administration of drugs or fluids cannot be counteracted. b. Injection of microorganisms, toxins, particulate matter, or air. c. Thrombosis at the site of injection or infusion. d. Extravasation of injections or infusions at the site of administration. e. The occurrence of physical or chemical incompatibilities between agents prior to or at the time of injection.
Intramuscular injections Site of injection Gluteal site Deltoid site Vastus lateralis site Ventrogluteal Dorsogluteal
Intramuscular injections Method of injection -Thoroughly clean the skin-insertion site using alcohol swab for 30 seconds and then allowed to dry -Prepare the injection aseptically.- -insert the needle into the patient skin at a 90 angle until approximately 1cm of the needle is left showing- -Aspirate before injection to ensure that the drug will NOT be administered intravenously.
Intramuscular injections Drug form Most liquid pharmaceutical forms can be given intramusculary Solution Suspension Emulsion Aqueous Oily Aqueous Colloidal Oily O/W W/O
Intramuscular injections Volume 1-5 ml for adults Much smaller volumes are acceptable in children
Intramuscular injections Indications 1. For a reasonably rapid systemic uptake of the drug (15-20 min). (I.M. route is second only to the I.V. route in rapidity of onset of systemic action). 2. For relatively prolonged action (1 to 2h up to several months) this is called de-pot. 3. To inject concentrated and irritant drugs that could damage subcutaneous tissue. (I M injections are less painful when administered correctly because skeletal muscles have fewer pain-sensing nerves 4. To inject relatively larger volumes than S.C. route (larger volumes can be absorbed because of the rapid uptake of the drug into the blood stream via the muscle fiber)
Intramuscular injections Precautions (complications) 1. Avoid entering a blood vessel (especially an artery), which might lead to: Infusion of a toxic agent or a toxic vehicle directly to an organ or tissue. Introducing a particulate matter from a suspension to a blood vessel which lead to clot formation. 2. The accidental striking of or injection into a peripheral nerve may result in a peripheral sensory damage. 3. If a large bolus of drug is injected, local damage or muscle infarction may result, leading to: A sterile abscess Elevation of serum levels of muscle enzymes. This may present confusing diagnostic problems, especially in patients under suspicion of having a myocardial infarction or hepatitis. 4. Septic abscesses may result if m.o. from the skin flora punched in by the needle at the time of injection. 5. The intramuscular route should never be employed in patients with significant heart failure or shock.
Subcutaneous injections Site of injection side of the arm front of the thigh back of the arm. abdomen
Subcutaneous injections Method of injection Beveled, 24 to 25 gauge, 1/4 to 5/8-in. long needle
Subcutaneous injections Method of injection -Thoroughly clean the skin-insertion site using alcohol swab for 30 seconds and then allowed to dry -Prepare the injection aseptically. - insert the needle into the patient skin at a 45 o or 90 angle -Aspirate before injection to ensure that the drug will NOT be administered intravenously. - Press or rub the site for a few seconds.
Subcutaneous injections Drug form Solution Fine particles low viscosity suspensions Volume 0.5-1.5 ml
Subcutaneous injections Indications For drugs which cannot be administered orally because of lack of absorption from or inactivation by the contents of the gastrointestinal tract (insulin, vaccines and narcotics)
Subcutaneous injections Limitations a. Absorption is slower and less predictable than by the intramuscular route.(due to little blood flow to fatty tissue) b. If heart failure, shock, or vascular collapse exists, this route should not be depended upon. c. Medications that are highly acidic, alkaline, or irritating, should not be administered by this route as they cause the production of pain, inflammation and necrosis of tissues. d. Subcutaneous injections are not given if the skin is burned, hardened, inflamed, swollen, or damaged by a previous injection