Parenteral Preparations

 Sterile products are dosage forms of therapeutic agents that are free from micro-organisms or their spores.

 1. Parenteral preparations  2. Ophthalmic preparations: for the eye  3. Otic preparations: for the ear  4. Nasal preparations : for the nose & throat  5. Irrigating solutions: for washing wounds or abraded mucous membrane

 Parenteral products are sterile dosage forms that are injected into body tissues (into internal body compartment) through one or more layers of skin or mucous membrane. Therefore, they must be exceptionally pure and free from physical, chemical and biological contaminants.

 Sterilization & Sterile Product  Pyrogen  SVP  LVP  Light Resistant Containers  Well closed containers  Tightly closed containers  Single dose container  Multiple dose container  Hermetically sealed container

 para: outside  enteron: intestine (i.e. beside the intestine) These are the preparations which are given other than oral routes.  Injections:  These are Sterile, Pyrogen free preparations intended to be administered parenterally (outside alimentary tract).

1) Rapid action 2) Oral route cannot be used 3) Not effective except as injection 4) Many new drugs particularly those derived from new development in biotechnologically can only be given by parenteral because they are inactivated in GIT if given orally. 5) New drugs require maintaining potency & specificity so that they are given by parenteral.

 Quick onset of action  Suitable for the drugs which are not administered by oral route  Useful for unconscious or vomiting patients.  Duration of action can be prolonged by modifying formulation.  Suitable for nutritive like glucose & electrolyte.  Suitable for the drugs which are inactivated in GIT or HCl (GI fluid)

 Once injected cannot be controlled (retreat)  Injections may cause pain at the site of injection  Only trained person is required  If given by wrong route, difficult to control adverse effect  Difficult to save patient if overdose  Sensitivity or allergic reaction at the site of injection  Requires strict control of sterility & non pyrogenicity than other formulation.  Requirement of aseptic technique in production, compounding and handling of product  Highly risky if any mistake at happens any point  High cost as compared to solid dosage form

 Must be free from viable micro-organisms or their spores.  Must be free from toxic components/pyrogens.  Must be free from chemical contaminants.  Must be free from foreign particles such as dust, fibres.  Safety level of all the ingredients should be same and every means of safety should be ensured including packaging material.  The pH of the product should be strictly maintained. Adequate buffers should be used.  Water used in parenteral products must be inert/sterilized.  Isotonicity of the product must be maintained.  Container of products must be free from pyrogens.  Water for injection should have conductivity < 1 μ mho.

 Sterility (must)  Pyrogen (must)  Free from particulate matter (must)  Clarity (must)  Stability (must)  Isotonicity (should)  Solvents or vehicles used must meet special purity and other standards.  Restrictions on buffers, stabilizers, antimicrobial preservative. Do not use coloring agents.  Must be prepared under aseptic conditions.  Specific and high quality packaging.

 PARENTERALS ARE ADMINISTERED BY:  Physician  Physician’s assistant  Nurse  PARENTERALS ARE ADMINISTERED AT:  Hospitals  Clinics  Extended care facilities

 Needles:  There are several factors which need to be considered in choosing the size of a needle to use for an injection or “shot”. They include such issues as  the type and viscosity of the medication  the size and age of the patient  the mobility status of the patient  the desired absorption rate for the medication

 In general for IM (intramuscular) injections you would use a 21 to 23 gauge needle 1 to 1.5 inches long for an adult. In a child you use a 1 inch long, 25 to 27 gauge needle. In obese patients, 1.5 to 2 inch needles may be necessary.  For SQ (subcutaneous) injections you would typically use a 25 to 27 gauge needle 3/8 to 5/8 inches long for adults and children alike. Some newer medications such as Byetta for diabetes recommend using 30 or 31 gauge 1/3 inch  The diameter of the needle is indicated by the needle gauge. Various needle lengths are available for any given gauge. There are a number of systems for gauging needles, including the Stubs Needle Gauge, and the French Catheter Scale. Needles in common medical use range from 7 gauge (the largest) to 33 (the smallest) on the Stubs scale. 21- gauge needles are most commonly used for drawing blood for testing purposes, and 16- or 17-gauge needles are most commonly used for blood donation, as they are wide enough to allow red blood cells to pass through the needle without rupturing (this also allows more blood to be collected in a shorter time). Larger-gauge needles (with smaller diameter) will rupture the red blood cells, and if this occurs, the blood is useless for the patient receiving it. Although reusable needles remain useful for some scientific applications, disposable needles are far more common in medicine. Disposable needles are embedded in a plastic or aluminium hub that attaches to the syringe barrel by means of a press-fit or twist-on fitting. These are sometimes referred to as "Luer Lock" connections, referring to the trademark Luer-LokgaugeStubs Needle GaugeFrench Catheter Scale   6 hypodermic needles on luer connectors; from top to bottom: 26G × 1/2" (0.45 × 12mm) (brown), 25G × 5/8" (0.5 × 16mm) (orange), 22G × 1¼" (0.7 × 30mm) (black), 21G × 1½" (0.8 × 40mm) (green), 20G × 1½" (0.9 × 40mm) (yellow), 19G × 1½" (1.1 × 40mm) (white)