SVP& LVP

of 108

  • date post

    02-Jun-2018
  • Category

    Documents

  • view

    216
  • download

    1

Embed Size (px)

Transcript of SVP& LVP

  • 8/11/2019 SVP& LVP

    1/108

    P RENTER L PRODUCTS

    MANJUL PRATAP SINGH ANITA SINGH

    KAILASH INSTITUTE OF PHARMACY MANAGEMENT, GIDA,

    GORAKHPUR

    09628373561

    K.I.P.M. GIDA, GORAKHPUR, U.P.

  • 8/11/2019 SVP& LVP

    2/108

    DEFINATION:

    Parenteralrefers injectable route of administration.

    It derived from Greek words Para (Outside) and enteron (Intestine). So it

    is a route of administration other than the oral route. This route of

    administration bypasses the alimentary canal

    Pyrogens, fever-producing substances are primarily lipid polysaccharide

    product of metabolism of microorganism; they may be soluble,insoluble, or colloid.

    K.I.P.M. GIDA, GORAKHPUR, U.P.

  • 8/11/2019 SVP& LVP

    3/108

    Parenteral Dose Forms

    Parenteral preparations must be sterile

    free of microorganisms

    To ensure sterility, parenterals are prepared using

    aseptic techniques

    special clothing (gowns, masks, hair net, gloves) laminar flow hoodsplaced in special rooms

    K.I.P.M. GIDA, GORAKHPUR, U.P.

  • 8/11/2019 SVP& LVP

    4/108

    Advantages of the Parenteral Route

    The IV route is the fastest method for delivering systemic drugs

    preferred administration in an emergency situation

    It can provide fluids, electrolytes, and nutrition

    patients who cannot take food or have serious problems with the

    GI tract

    It provides higher concentration of drug to bloodstream or tissues advantageous in serious bacterial infection

    IV infusion provides a continuous amount of needed medication

    without fluctuation in blood levels of other routes

    infusion rate can be adjusted

    to provide more or less medication as the situation dictates

    Drug action can be prolonged by modifying the formulation.

    K.I.P.M. GIDA, GORAKHPUR, U.P.

  • 8/11/2019 SVP& LVP

    5/108

    Disadvantages of the Parenteral Route

    Traumatic injury from the insertion of needle

    Potential for introducing:

    Toxic agents

    Microbes

    Pyrogens Impossible to retrieve if adverse reaction occurs

    injected directly into the body

    Correct syringe, needle, and technique must be used

    Rotation of injection sites with long-term use

    prevents scarring and other skin changes

    can influence drug absorption

    K.I.P.M. GIDA, GORAKHPUR, U.P.

  • 8/11/2019 SVP& LVP

    6/108

    Routes of Administration of parenteral products

    Various types of route of administration of parenteral products are:

    Intradermal injection Subcutaneous (Hypodermis) injection

    Intramuscular injection

    Intravenous injection

    Intra-arterial injection

    Intracardiac injection

    Intrathecal injection

    Intracisternal injection

    Peridural injection

    Intra- articular injection

    Intracerebral injection

    K.I.P.M. GIDA, GORAKHPUR, U.P.

  • 8/11/2019 SVP& LVP

    7/108

    Subcutaneous Injections

    Given at a 45-degree angle

    25- or 26-gauge needle, 3/8 to 5/8

    inch length

    No more then 1.5 ml should be injected

    into the site

    to avoid pressure on sensory nerves

    causing pain and discomfort

    Administer medications below the skin into the subcutaneous fat

    outside of the upper arm

    top of the thigh

    lower portion of each side of the abdomen

    not into grossly adipose, hardened, inflamed, or swollen tissue

    Often have a longer onset of action and a longer duration of action

    compared with IM or IV injection

    K.I.P.M. GIDA, GORAKHPUR, U.P.

  • 8/11/2019 SVP& LVP

    8/108

    Intramuscular Injections

    Care must be taken with deep IM injections to avoid hitting a vein,

    artery, or nerve In adults, IM injections are given into upper, outer portion of the

    gluteus maximus

    large muscle on either side of the buttocks

    For children and some adults, IM injections are given into the deltoidmuscles of the shoulders

    Typical needle is 22- 25 gauge - to 1-inch needle

    IM injections are administered at a 900angle

    volume limited to less than 3 ml

    K.I.P.M. GIDA, GORAKHPUR, U.P.

  • 8/11/2019 SVP& LVP

    9/108

    Intravenous Injections or Infusions

    Fast-acting route because the drug goes directly into the

    bloodstream

    often used in the emergency department and in critical care

    areas

    Commonly used

    for fluid and electrolyte replacement to provide necessary nutrition to the patient who is critically ill

    Intravenous (IV) injections are

    administered at a 15- to 20-degree

    angle

    K.I.P.M. GIDA, GORAKHPUR, U.P.

  • 8/11/2019 SVP& LVP

    10/108

    Intra-arterial injection

    Intracardiac injection

    Intrathecal injectionThese are given into the subachonoid space the

    surround the spinal cord. This route is used for

    spinal anesthesia.

    These are given into the heart muscle or ventricle

    at the time of emergency only.

    The inaction are given directly in to the artery

    K.I.P.M. GIDA, GORAKHPUR, U.P.

  • 8/11/2019 SVP& LVP

    11/108

    Intracisternal injection

    These are given in b/w first & second cervical nerve.

    Used for CSF for diagnostic purpose.

    Peridural injectionThese are given in b/w the dura matter & inner aspect

    of vertebra.

    Used for given spinal anesthesia.

    Intra- articular injection

    These are given in into the articulating ends of bones in

    a joint.

    Used for lubricating the joints.Intracerebral injection

    These are given into the cerebrum.

    K.I.P.M. GIDA, GORAKHPUR, U.P.

  • 8/11/2019 SVP& LVP

    12/108

    Official types of injections

    Injection: Liquid preparation there are drug substance ordrug solution thereof e.g. insulin injection USP.

    For injection: Dry solid that upon addition of suitable vehicles yieldsolutions confirming in all respect to the requirements to the

    injection. e.g. Cefuroxime injection USP.

    Injectable emulsions: Liquid preparation of drug substancedispersed in a suitable emulsion medium. e.g. Propofol USP.

    Injectable suspension: Liquid preparation of solid suspended in a

    suitable medium. e.g. Methyl Prednisolone Acetate Suspension USP.

    For injectable suspension: Dry solid that upon addition ofsuitable vehicle yields preparation confirming in all respect

    to the requirements for Injectable suspension.

    e.g. Imipenem and Cilastatin injectable suspension USP.K.I.P.M. GIDA, GORAKHPUR, U.P.

  • 8/11/2019 SVP& LVP

    13/108

    General requirements of parenteral preparations

    Stability

    Sterility

    Free from Pyrogens

    Free from foreign particles

    Isotonicity

    Specific gravity

    Chemical purity

    K.I.P.M. GIDA, GORAKHPUR, U.P.

  • 8/11/2019 SVP& LVP

    14/108

    Formulation of parenteral products In the preparation of parenteral products, the following substances

    are added to make a stable preparation:

    The active drug

    Vehicles

    Aqueous vehicle (e.g. water for injection, water for injection free from CO2 )

    Non-aqueous vehicle (e.g. Ethyl alcohol, propylene glycol, almond oil)

    Adjuvants

    Solubilizing agents (e.g. Tweens & polysorbates)

    Stabilizers & antioxidants (e.g. thiourea, ascorbic acid, tocopherol)

    Buffering agents (e.g. citric acid, sodium citrate)

    Antibacterial agents (e.g. benzyl alcohol, metacresol, phenol)

    Chelating agents (e.g. EDTA)

    Suspending, emulsifying & wetting agents (e.g. MC, CMC)

    Tonicity factor (e.g. sodium chloride, dextrose)

    K.I.P.M. GIDA, GORAKHPUR, U.P.

  • 8/11/2019 SVP& LVP

    15/108

    PREFORMULATION FACTORS

    It is study about physical & chemical properties of drug substance

    prior formulation is called as preformulation.

    They are

    pH /pka

    Solubility

    Thermal/heat effect

    Dissociation constant

    Compatabilty studies- FTIR / DSC

    Oxidation & reduction

    particle sizeK.I.P.M. GIDA, GORAKHPUR, U.P.

  • 8/11/2019 SVP& LVP

    16/108

    pH and pKa SOLUBILITY PROFILE

    pKa Determination: The Henderson Hasseslebach equation

    provides an estimate of the ionized and un ionized durg concentration

    at a particular pH.

    For acidic drugs,

    pH = pKa + log (ionized drug) / un-ionized drug)Forbasic drugs,

    pH = pKa + log (unionized drug / ionized drug )

    Buffers, temperature, ionic strength and cosolvent can affect the pKa

    value.

    Potentiometric titration offers maximum sensitivity for

    compounds with pKa values in the range of 3-10.K.I.P.M. GIDA, GORAKHPUR, U.P.

  • 8/11/2019 SVP& LVP

    17/108

    SOLUBILIZATION

    Solubilization is increased by co solvent addition.

    E.g.- propylene glycol solubilize drug molecules by

    disrupting the hydrophobic interactions of water.

    More non polar the solute

    greater is the solubilisation

    achieved by co solvent addition

    K.I.P.M. GIDA, GORAKHPUR, U.P.

  • 8/11/2019 SVP& LVP

    18/108

    THERMAL/HEAT EFFECTS

    Drugs which are unstable to heat requires refrigerative storage or

    lyophilisation (these products must be used within short periods)

    If it is endothermic---> H is +ve

    increase in temp ---> increase in drug solubility

    If it is exothermic---> H is ve

    increase in temp ---> decrease in drug solubility

    For determini