Laboratorium Teknologi Farmasi Laboratorium Teknologi Farmasi Fakultas Farmasi UGM Definisi Definisi A drug delivery system (DDS) is defined as a Adrugdeliverysystem(DDS)isdefinedasa formulationoradevicethatenablesthe introduction of a therapeutic substance in the introductionofatherapeuticsubstanceinthe bodyandimprovesitsefficacyandsafetyby controlling the rate time and place of release controllingtherate,time,andplaceofrelease ofdrugsinthebody. This process includes the administration of the Thisprocessincludestheadministrationofthe therapeuticproduct,thereleaseoftheactive ingredients by the product and the ubsequent ingredientsbytheproduct,andtheubsequent transportoftheactiveingredientsacrossthe biological membranes to the site of action biologicalmembranestothesiteofaction. Drug delivery system is an interface between the patient and the drug. It may be a formulation of the drug to administer it for a therapeutic purpose or a device used to deliver the drug. This distinction between the drug and the This distinction between the drug and the device is important, as it is the criterion for regulatory control of the delivery system by regulatory control of the delivery system by the drug or medicine control agency. d i i i t d d i t th h b d f device is introduced into the human body for purposes other than drug administration, such th ti ff t b h i l d lit as therapeutic effect by a physical modality or a drug may be incorporated into the device for ti li ti lti f th preventing complications resulting from the device, it is regulated strictly as a device. Thereisawidespectrumbetweendrugsand devices,andtheallocationtooneortheother categoryisdecidedonacasebycasebasis. DrugDeliveryRoutes Categories of Pharmaceutical Dosage Forms FIRST TIER CATEGORY DELIVERY ROUTE [i.e. based on tissues to which active delivered] Mucosal Membranes Skin surface IV IM etc SC Gastro-intestinal Tract lungs Tissues or Body Fluids [by injection] l otic i l etc [by injection] nasal otic ophth- vaginal oral topical dermal trans- ophth- rectal topical almic urethral oro- phary ngeal 6 6 7 4 3 8 9 4 7 6 10 5 USPC2000 12 Job# 03/08/07 10:04 PM SECOND TIER CATEGORY DOSAGE FORM [i.e. based on the general type of dosage form] [ Indicates page number of second tier] [Dermal] Categories of Pharmaceutical Dosage Forms Skin surface [NOTE: May preface titles with topical , e.g. Topical cream ] topical SECOND TIER CATEGORY DOSAGE FORM [i.e. based on the general type of dosage form] 8 SECOND TIER CATEGORY DOSAGE FORM [i.e. based on the general type of dosage form] solids semi-solids patches powders liquids collodions solutions ointments plasters aerosols suspensions films foams pastes gauzes emulsions w/o creams tapes / gels USPC2000 13 Job# 03/08/07 10:04 PM THIRD TIER CATEGORY TYPE OF RELEASE [i.e. based on the RELEASE PATTERN OF THE ACTIVE] o/w gels sticks Categories of Pharmaceutical Dosage Forms [possible common Third Tier categorization] THIRD TIER CATEGORY TYPE OF RELEASE [i.e. based on the RELEASE PATTERN OF THE ACTIVE] Conventional release Modified release (immediate release) * Extended release Delayed release [Slower rate] [Delayed onset] P l til l Targeted release [Delayed onset] [Specific organ/tissue] *Use of conventional release is encouraged. The termimmediate has been widely used in place of the less misleading and more appropriate term conventional with reference to dosage form nomenclature Orally disintegrating Pulsatile release [Faster rate than conventional] [Fractions released at time intervals] nomenclature. USPC2000 14 Job# 03/08/07 10:04 PM Orally dispersing [Faster rate than conventional] New Desain Drug Delivery NewDesainDrugDelivery SustainedReleaseOralDosageForm SustainedReleaseInjectableDosageForms SustainedReleaseTopicalDosageForms Implants And Iuds ImplantsAndIuds TransdermalDrugDeliverySystem(TDDS) Targeted Delivery Systems TargetedDeliverySystems Liposomes Nanoparticles Polymers MonoclonalAntibodies TransmucosalDrugDeliverySystems InhalationSystems BuccalDelivery RectalDelivery VaginalDelivery OcularDelivery Others Vaccines PolyclonalAntibodies ConsiderableadvanceshaveoccurredinDDS withinthepastdecade.Extendedrelease, controlledrelease,andonceadaymedications il bl f l l d d areavailableforseveralcommonlyuseddrugs. Global vaccine programs are close to becoming a li i h h f l l reality with the use of oral, transmucosal, transcutaneous, and needleless vaccination. Considerableadvanceshavebeenmadeingene therapyanddeliveryofproteintherapeutics. Many improvements in cancer treatment can be attributed to novel drug delivery technologies. New drug delivery systems will develop during the next decade by interdisciplinary collaboration of material scientists, engineers, biologists, and pharmaceutical scientists. Progress in microelectronics and Progress in microelectronics and nanotechnology is revolutionalizing drug delivery delivery.