What is depot formulation

Manufacture means the production of products in a factory using labour, materials, components and machinery and includes other related value-adding activities. Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.

Food and Drug Administration for use in treating nicotine or tobacco dependence. Dose is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent.

For purposes of these regulations, "radiation dose" is an equivalent term. Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;. Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. Vaccine means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.

Drug Product means a specific drug in dosage form from a known source of manufacture, whether. Since then, a few other atypical depot products have also been approved by the FDA. In spite the success of these products, they typically display certain limitations including:. Our technologies overcome these barriers by extending the drug release to potentially as long as one year while maintaining zero order release pharmacokinetics.

Physicians and their patients have the flexibility to begin or interrupt the treatment at any time without having to worry about a complex dosing schedule during treatment initiation, or a long washout period after treatment interruption. No data available for switching to another antipsychotic. Presented by- Miss Shraddha M. Kumbhar M. Pharm Pharmaceutics Satara college of Under the guidance of - Dr. Ajit S. Depot: Long acting parenteral drug formulation is designed, ideally to provide slow, constant, sustained, prolonged action.

The release can either be continuous or pulsatile depending on the structure of the device and the polymer characteristics. Polymers used…… Generally, Biodegradable polymers are used as it get degraded in the body. Dissolution controlled depot formulation 2. Adsorption type depot formulation 3. Encapsulation type depot formulation 4. Esterification type depot formulation 7 8.

Dissolution controlled depots RDS of drug absorption is dissolution of drug. Example: aqueous suspension of testosterone isobutyrate for intramuscular administration. Adsorption type depots This depot preparation is formed by the binding of drug molecules to adsorbents. Example: vaccine preparations in which the antigens are bound to highly dispersed aluminum hydroxide gel to sustain their release and hence prolong the duration of stimulation of antibody formation.

Encapsulation-type depots prepared by encapsulating drug solids. Biodegradable or bio absorbable macromolecules are used, e. Example: naltrexone pamoate — releasing biodegradable microcapsule, 10 Esterification-type depots produced by esterifying a drug to form a bioconvertible prodrug-type ester. The rate of drug absorption is controlled by the interfacial partitioning of drug esters from the reservoir to the tissue fluid and the rate of bioconversion.

Example: fluphenazine enanthate, nandrolone decanoate in oleaginous solution. Inject able drug delivery B. Implantable drug delivery system C. Infusion devices D. Recent advances 12 Injectable Drug Delivery 1. Thermoplastic pastes 2. In situ cross linked systems 3. In situ polymer precipitation 4. Thermally induced gelling system 5.

In situ solidifying organogels. When this formulation is injected into the body, the water miscible organic solvent dissipates and water penetrates into the organic phase. This leads to phase separation and precipitation of the polymer forming the depot at the site of injection 15 SLNs combine advantages of polymeric nanoparticles, fat emulsions and liposomes. Nanosuspensions: Nanosuspensions of drugs are submicron colloidal dispersions of drug particles which are stabilized by surfactants.

Nanocrystals are crystals of poorly water soluble drug in nanosize. Used when drug have high melting point. Niosomes These are nonionic surfactant vesicles obtained on hydration, with or without incorporation of cholesterol or other lipids.