and routes of administration 2 Information about drugs 3 Drug legislation in CZ What is a dosage form It is a final form in which ID: 1045882
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1. 1. Drug dosage forms and routes of administration2. Information about drugs3. Drug legislation in CZ
2. What is a dosage form?It is a final form, in which the drug is given to the patient.
3. Dosage FormMixture of substances with therapeutical effect and excipientsExcipients: antioxidants, fillers, pigments (dyes), fragrances, ointment bases, solvents etc.No pharmacological effectAllergies (parabens), intolerance (lactose)Shape and characteristics of a medical preparationAdjusted to the route of administrationInfluence pharmacokinetics of a medical substanceGenerations of dosage forms:1st = classic dosage forms2nd = controlled release 3rd = controlled biodistributionExcipients of AERIUS tablets:Core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, talc. Coating: lactose monohydrate, hypromellose, titanium dioxide, macrogol 400, indigotin, carnauba wax, white wax.
4. Classification of Dosage FormsAccording to the consistency:solidsemi-solid liquidgaseousAccording to the usage:for internal use (Ad usum internum, e.g. Peroralia, Parenteralia) for other use (Ad usum alium, e.g. Ocularia, Nasalia, Unguenta).
5. Liquid Dosage Formsa) For internal use:1. (Per)oral liquids– solutions, suspension, emulsion for per os administration– tinctures, drops, syrups2. Parenteral liquids – injections– infusionsb) For external use:– eye drops, ocular waters, ear drops, nasal drops– liquids for cutaneous use, for compresses– liquids applied to the mucosa (douche – irrigation, gargle)
6. Semi-solid Dosage FormsApplied on the skin or mucosaLocal effect (dermatology) Systemic effect (TTS)Ointment (unguent) Creme Gel (jelly) Paste Transdermal patch(TTS, Emplastra)
7. Solid Dosage FormsSpecific in shape:Tablet SuppositoryVaginal pessary (suppository) CapsuleLozenge (pastilles)Non-specific in shape:Dusting powder Herbal mixturePeroral powder:ClassicGrainedEffervescent
8. Tablets and CapsulesTablets:UncoatedCoatedGastro-resistantEffervescentTablets disperged in the mouth ChewableSublingualetc.Capsules:Hard SoftGastro-resistantWith modified releaseetc.
9. Gaseous Dosage Forms = AerodispersionsTopical ear, nasal, oral, sublingual and cutaneous sprayPreparations for inhalationliquids (scattering of liquid drops)powders (particle size determines the place of absorption)Foamscutaneous, rectal, vaginal foamsMaking of an aerodispersion:Mechanically by a nebulizer (spray)By liquefied/compressed gas (pressure container)
10. https://www.youtube.com/watch?v=9VXdBprFIwchttps://www.youtube.com/watch?v=3FqBBQJsl2o
11. Routes of administrationSystemic administration= drug is absorbed into the circulation → it influences all the body Enterální aplikace:enteral parenteral Local (topical) administration= drug is NOT absorbed into the circulation → it affects only the place of application:skin, mucosa, e.g. conjunctiva:GIT, but the drug in not absorbed from GITHow could a drug be administered?
12. Systemic administration – enteral(Per)oral (per os, p.o.) Enteron (ancient greek) = intestineOnset of effect depends on phys-chem. properties of the medical substance and excipientsPossibility of lower bioavailability: first-pass effect (liver)Rectal (per rectum)Do not irritate stomach, do not cause nauseaLower bioavailability – lesser surface of rectum wallsSooner onset of effect – plexus venosus rectalis flows into vena cava inferior („bypass of the liver“)
13. „First pass“ effect
14. Systemic administration – parenteralPara enteron (ancient greek) = out of the intestine1. Non-injection (non-invasive)a) oralAbsorption by oral mucosa (e.g. subligual)Lipophilic substances – quick absorption (2 mins), e.g. nitroglycerinb) inhalationGases, vapours nebo small particlesRespiratory diseases (asthma, COPD...) c) transdermal TTS = transdermal therapeutic system (controlled release)E.g. hormonal contraception patch, nicotine patch, analgesic patchd) transnasal Good perfusion of nasal mucosaSubstances could irritate it, or impair cilia functionE.g. calcitonin, antimigraine drugse) vaginal – e.g. hormonal contraception ring
15. Systemic administration – parenteral2. Injection (invasive)- non-physiologicala) injectionsmall volume of liquidi.v. administration – quick onset of effecti.m., s.c. – gradual absorption into circulationb) infusionlarger volume of liquidparenteral nutrition, minerals, glucose, ATBs, cytostatics etc.
16. What is this tablet?What is this drug used for?How frequently should I use it?What are possible adverse effects?Who must not use it?What is an appropriate dose?How to store it?Does it influence vigility?Could this drug influence the effect of other drugs??????
17. Information about DrugsPIL & SPCPIL = patient information leaflet = package leaflet for patientsSPC = summary of product characteristics = information for medical specialists (physicians, pharmacists, nurses etc.) EMA – European Medicine Agency (ema.europa.eu)Database of RMPs granted central authorisation by EC/EMAReports concerning drugs‘ safety – alertsList of newly authorized drugsSUKL – State Institute for Drug Control (sukl.eu)Database of RMP authorized in CZFree access to all PILs and SPCs (in czech)European Pharmacopoeia = european standard for the quality of drugs (Czech Pharmacopoeia = text from EP + czech specialities) Computer databases of medical preparationsAISLP (czech↔english, in most pharmacies and doctor‘s offices)
18. PharmacopoeiaPurpose: to guarantee safe, effective and quality drugsInformation about medical substances, excipients, dosage formsInstructions for production, preparation, control, storage of drugsUsed mostly in pharma industryWhat could we found there?Analytical and instrumental examination methodsMaterials for drug containers and casesInstructions to ensure sterility of medical preparationsInstructions concerning radiopharmaceuticals, vaccines etc.Monographs of specific substancesTables with usual dosage of drugs in adults, children, animalsetc.NO: mechanism of actions, adverse effects, pharmacokinetics, contraindications, pregnancy safety etc.!
19. Basic Drug Legislation in CZAct No. 378/2007 Coll., on pharmaceuticals ResearchAuthorization of new drugs („registration“)Production, preparation and distributionPrescribing and dispense of medical preparationsDestroying of unusable drugsPharmacy dutiesPharmacovigilance = drug safety serviceControls and sanctions
20. Medical Prescription (Rx) in CZValidity:classic Rx: 14 daysRx for ATBs: 5 daysRx for local ATBs: 14 daysDrugs of abuse and psychotropic substances (special Rx form): 14 daysRx for repeated use: 6 months, max. 1 yearRx from ED: day after the day of making up (= max. 48 h)
21. Legislation – Drugs of AbuseAct No. 167/1998 Coll. on Dependency Producing Substances & Order of the Government 463/2013 Coll. regarding the lists of dependency producing substancesSpecified narcotic and psychotropic drugsshould be strictly monitored:Keeping files of accepting and dispensing – „Opiates Book“SUKL require this information Special Rx form – with oblique blue stripMedical preparations and Rx forms shouldbe stored in a safe or vault!
22. Classification of narcoticsGroup 1 → Rx with blue stripHighly addictiveE.g. strong opioid analgesicsmorphineoxycodonefentanyl etc.Group 2Lower risk of addictionClassic Rx formE.g. codeineGroup 3 = „forbidden substances“No therapeutic useMisusedSometimes used in the researchE.g. hashish, heroin etc..
23. Classification of psychotropic drugsGroup 1 = „forbidden substances“Hallucinogens, psychostimulantsE.g. MDMA (exstasy)Group 2 → Rx with blue stripMisused psychostimulants, addictive E.g. methamphetamine and other amphetaminsTherapeutically used: e.g. methylphenidate, buprenorphineGroup 3Barbiturates, risk of addiction, limited therapeutic useE.g. pentobarbitalGroup 4Benzodiazepines, barbiturates and otherpotentially addictive drugsClassic Rx. formHypnotics, sedatives, antiepileptics etc.E.g. diazepam, oxazepam, phenobarbital…
24. Precursors= substances used in the production of addictive and psychotropic substances classic Rx (except pseudoephedrine)ephedrine – nasal drops in sinusitispseudoephedrine – medical preparation for cold treatment→ OTC with restrictionergotamine – antimigraine suppositoriesergometrine – obstetrics