dosage

dosage form or drug delievery system

general area of study concerned with the formulation, manufacuring, stability and effectiveness of pharmaceutical dosage form

a specific quantitiy of a drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture

regulatory process through which industry measure actual quality perfomance compare it with standards and acts on the difference

activity of providing the evidence needed to establish confidence that the activities related to quality are being perfomed adequately

• medicinal gases, inhalation volatile anaesthetic
• aerodispersions of solid particles( anti asthmatic inhalations) or liquid particles ( anti asthmatic inhalations or sprays)

• solutions
• emulsions
• suspensions

• unshaped:
• gels, creams, ointment and pastes
• shaped
• suppository and pessary

• P.O
• S.L.
• rectal
• parenteral
• transdermal
• pulmonary
• nasal

• occular, nasal, octic
• buccal
• rectal, vaginal
• pulmonary
• percutaneous, topical

• oral cavity :7
• esophagus 5-6
• stomach 1.4 -3.5
• duodenum 4-5
• ileum 5 -8

• convenient
• absorption takes place along the whole length of the Gi
• cheap
• easily protable

• effect too slow for emergencis
• unpleasent tast
• irritation to gastric mucosa nausea and vomiting
• destruction of durgs by gastric acid and digestive juices
• hepatic firs pass
• unable to use in unconscius patient
• high risk of durg drug and drug nutrient interactions

• rapid absorption and onset of action
• can be used in unconscious patients
• avoid first pass effect

• not effective if patient has a dry mouth
• not effective if swallowed
• unpleasant taste of some drugs

• solution, ointments and suppositories
• superior hemorrhoidal vein( inferior mesentric > hepatic portal> liver)
• middle and inferior( iliac vein> inferior vena cava)

• the effect of digestive enzymes is avoided
• useful for unconscious patients and in vomiting
• good option in pediatric population
• may avoid first pass metabolism

• absorption is slow an irregular and unreliable
• patient acceptance

injection suspensions are slower acting than injectable solutions injections leading to slower absorption characteristis.

• sc...
• im
• iv
• intradermal .... diagnostic measures arm and back

• for drugs that are poorly absorbed from the gastrointestinal tract
• for agents such as insulin that are unstable in the GI
• for unconscious patients
• for emergencies
• avoid hepatic first pass

• can't be removed in case of toxicity
• sometimes more expensive
• fromulation needs sterility
• requiers trained person for administration
• may be invasive
• risk of pain/ irritation at the site of injection

• provides a controlled release
• good compliance
• delivery of the drug can be immediately discontinued
• no degradation in the gI
• avoid first pass

• skin is a very effective barrier
• high doses can not be accommodated and deliverd
• local reactions

• fast druge delivery to blood
• avoids first pass
• no GI degradation

• coordination between activating the inhaler and inspiration may be required
• might be difficult

• applied where action desired
• easy to use

• inaccuracy of dose
• stain clothes
• allergic reaction

• to optamize manufacture and durge use
• to guarantee the optimal release profile and the required stability
• to keep manufacturing cost as low as possible

• reverse osmosis
• distilation
• ion exchange system

• a carrying agent for a drug substance. they are used in formulating a variety of liquid dosage forms for oral and parenteral administration
• ex: syrup

• an agent capable of holding other molecules onto its surface
• ex: activated charchoal

• an agent responsible for developing pressure within an aerosol container and expelling the product when the valve is opend
• ex: hydrofluoroalkane

• an agent used to form thing shells for the purpose of enclosing a drug substance or drug fromulation
• ex" gelatin

• used to impart color to liquid and solid pharmaceutical preparation
• ex: FD&C RED NO 3 AND 2O

• used to impart a pleasant flavor and often odor to preparation
• ex: peppermint oil

• used to impart sweetness to prepartion
• ex: aspartame and glycerin

• used to prevent drying out of prepartion
• ex: glycerin

• a liquid used as an intervening agent to reduce particle size of a drug powder by grinding
• ex: glycerin

• used as a component of film coating solution to enhance the spread of the coat over tablets and granules
• ex: glycerin

• the semisolid vehicle into which drug substance may be incoporated in preparing medicated ointments
• ex: lanolin

• used as a vehicle into which drug substance are incorporated
• ex: cocoa butter

• substances which absorb to surfaces or interfaces to reduce surface or interfacial tension
• may be used as wetting agents detergents or emulsifying agent
• ex: sodium lauryl sulfate and sorbitan monopalmitate

• used to promot and maintain the dispersion of finely subdivided particles of a liquid in a vehicle in which it is immiscible
• ex: sorbital monopalmitate

• a viscosity increasing used to reduce the rate of sedmentation of drug particles dispersed throughout a vehicle in which they are not soluble
• ex: hydroxylethyl cellulose and hydroxypropyl cellulose

• substances used to cause adhesion of powder particles in tablet granulations
• ex: carboxymethylcellulose and gelatin

• substance used in tablet formulations to reduce friction during tablet compression
• ex: stearic acid and zinc stearate

• inert substance used as fillers to create the desired bulk flow properties and compression characteristics in the preparation of tablets and capsules
• ex: lactose

• used to coat a formed tablet for purpose of
• protecting against durg decomposition by atmospheric oxygen or humidity
• to provide a desired release pattern for the drug substance afteradministration
• to maskthe tastorodorofthe drugsubstance
• foraesthetic purposes
• ex: hydroxyethyl cellulose and hydroxyprpyl methylcellulose

• used to impart and attractive shine to coated tablets
• ex: white wax and carnauba wax

• used to render a solution similar in osmotic characteristics to physiologic fluids
• ex: dextrose and soduim chloride

• decrease oxidation and increase stability
• ex: vitamies a and E

• used to change consistency of a preparation to render it more resistant to flow
• ex: methylcellulose

• used to prevent microbila growth
• ex: methy paraben and propyl paraben

• used in liquid prepartions to provide acidic medium for product stability
• ex: acetic acid and hydrochloric acid

• used in liquid preparation to provide alkaline medium of product stability
• ex: sodum hydroxide

is a term used to define the entire process of bringing a new drug or device to the market includes drug discovery/product development, pre clinical and clinical trails

• space the gap
• provid data on safety and efficacy
• includes:
• in vivo and vitro studies
• drug manufacturing, formulation and packaging

• assess drug effects on cells :
• cytotoxcicity
• assay of enzyme activity
• receptor binding
• protein interaction with signal transduction

• Pk study- adme study
• pd study
• therapeutic index
• toxicological study

• effect on reproductive system and teratogenicity
• mutagenicity
• carcinogenicity

• investigational new drug
• fda for getting approval for testing drug in humans

• the chemical structure of the compound
• how it is thought to work in the body
• any toxic effects found in the animals study
• how the compund is manufactured
• how, where and by whom the new studies will be conducted

• the clinical trail muct minimize the risk for participants
• provision for care of the patients
• terminate the trial when the risk becomes incompatible with the goals of the trial
• adverse events to be reported immedialely to an ethical committe

• reviews a protocol befor the study is allowed to start
• their job is to ensure that the risks of being in the study are not greater than the potential benefit

• institutional review board
• to ensure the rights and welfare of the participants
• review clinical tral protocols for ethical and legal issues
• has the authority to approve, modify or disapprove it
• they are monitored by the FDA

• purpose
• medicine to be studie
• procedure and schedule
• risks
• potential benefits
• alternatives to participation
• confidentiality

• healthy volunteers
• purpose to determine safety profile
• 1 identify metabolic and pharmacological effects of druge in humans
• determine the side effects associated with increasing doses
• gain early evidence on effectiveness
• sufficient information about the drug's pharmacokinetics and pharmcological effects is required
• 1-1.5 years

• to obtain some preliminary data on the effectiveness of the drug for a particular indication in patients with the disease or condition
• help determin the short term sid effects and risks
• 2 years

• expanded trails
• additional information about effectiveness and safety
• provid an adequate basis for extrapolating the results to the general population and transmitting that information in the physician labeling
• 3-3.5 years

• new drug application
• for FDa approve a new pharmaceutical for sale and marketing
• several thousand pages
• 1.5-2.5 years to read it

• whether the drug is safe and effective in its proposed use and whether the benifites of the drug outweigh the risks
• wether the drugs proposed labeling package insert is appropriate and what it should contain
• whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve drug's identitiy strength quality and purity

• carried out once the drug is apporved and marketed
• aim to find out safety profile in larg patient pool
• might reveal new therapeutic indication

• filed for generic products
• following the expiration of patent term protection of the innovator drug/drug product
• bioavilablity and bioequivalency studies