MIDTERM 1 TOPIC Flashcards
is a valuable component of an effective quality system.
QUALITY RISK MANAGEMENT
defined as the combination of the probability of occurrence of harm and the severity of that harm.
RISK
Risk is commonly defined as the combination of the probability of occurrence of _____ and the _____ of that harm.
HARM, SEVERITY
50-200 healthy subjects (usualy) or patients who are not expected to benefit from the IMP
PHASE 1
100-400 patients with the target disease.
PHASE 2
1000-5000 patients with the target disease
PHASE 3
Many thousands or millions of patients with the target disease
PHASE 4
It is important to understand that product ______ is assured based on appropriate risk based decision-making throughout the product lifecycle, such that the attributes that are important to the quality of the drug (medicinal) product are maintained and the product remains safe and effective.
QUALITY
It is important to understand that product quality is assured based on appropriate risk based _____ throughout the ______, such that the attributes that are important to the quality of the drug (medicinal) product are maintained and the product remains safe and effective.
DECISION-MAKING
PRODUCT LIFECYCLE
is a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle.
QUALITY RISK MANAGEMENT
Quality Risk Management is a systematic process for the _____, _____,______ and _______ to the quality of the drug (medicinal) product across the product lifecycle.
ASSESSMENT, CONTROL, COMMUNICATION , REVIEW OF RISK
3 Risk Assessment
HAZARD IDENTIFICATION
RISK ANALYSIS
RISK EVALUATION
2 Risk Control
RISK REDUCTION
RISK ACCEPTANCE
The purpose of ________ is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions.
STABILITY TESTING
3 environmental factors of stability testing
TEMPERATURE
HUMIDITY
LIGHT
different in all the countries in the world.
CLIMATE
Stability studies of the pharmaceutical drug should be done according to the
______ conditions of the country.
CLIMATE
According to the ICH guidelines for stability studies, the climate of the world is divided into _____ different zones.
FIVE
According to the ICH guidelines for stability studies, the climate of the world is divided into ____ different zones.
FIVE
According to the ICH guidelines for stability studies, the climate of the world is divided into ____ different zones.
FIVE
Temperate zone
ZONE I
Temperate zone
ZONE I
Mediteranean/subtropical zone
ZONE II
Hot dry zone
ZONE III
Hot humid/tropical zone
ZONE IVa
Hot/higher humdity
ZONE IVb
can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used.
STRESS TESTING
testing should be an integral part of stress testing.
PHOTOSTABILITY
Data from formal stability studies should be provided on at least _____ of the drug substance.
THREE PRIMARY BATCHES
should be conducted on the drug substance packaged in a container closure system that is the same as or simulates the packaging proposed for storage and distribution.
STABILITY STUDIES
The long-term testing should be performed over a minimum of ____ months at 25 ° C ± 2 °C/60% RH ± 5% RH or at 30 °C ± 2 °C/65% RH ± 5% RH.
12
In general, a drug substance should be evaluated under ________ (with appropriate tolerances) that test its thermal stability and, if applicable, its sensitivity to moisture
STORAGE CONDITIONS
The ______ and the lengths of studies chosen should be sufficient to cover storage, shipment, and subsequent use.
STORAGE CONDITION
defined as failure to meet its specification.
SIGNIFICANT CHANGE
_____ of pharmaceutical formulations is an essential operation in the production of drugs.
QUALITY CONTROL
It is a procedure or set of procedures designed to ensure the output of uniform batches of drugs conforms to the established specifications.
QUALITY CONTROL
different types of dosage forms:
SOLID DOSAGE FORM
LIQUID DOSAGE FORM
SEMI-SOLID DOSAGE FORM
GAS DOSAGE FORM
______ means a physical form by which drug molecules are delivered into the site of action.
DOSAGE FORM
are the most commonly used dosage form because of the stability and ease of mass production.
SOLID DOSAGE FORM
which are solid in nature which contain one or more drugs for therapeutic effects and excipients like Binders, Sweeteners, coloring agents, etc.
SOLID DOSAGE FORMS
Examples of Solid Dosage Form:
TABLETS
CAPSULES
GRANULES
SACHETS
POWDERS
DRY POWDERS
INHALERS
CHEWABLE
•More stable than other dosage forms.
• Easy to handle.
• More accurate of the dosage form.
• No preservation required.
ADVANTAGES OF SOLID DOSAGE FORMS
• Expensive Machines.
• Tough to swallow for kids and patients in sleeping condition.
DISADVANTAGES OF SOLID DOSAGE FORMS
• Tablets
• Capsules
• Granules
• Sachets
• Lozenges
• Pills
• Dry powder inhaler
• Chewables
UNIT DOSE
• Powder (External and Internal)
BULK DOSE
It is a procedure or set of procedures designed to ensure the output of uniform batches of drugs conforms to the established specifications.
QUALITY CONTROL
It is a procedure or set of procedures designed to ensure the output of uniform batches of drugs conforms to the established specifications.
QUALITY CONTROL
compressed solid dosage form contain therapeutic active ingredients and excipients.
TABLET
are solid dosage forms where the therapeutic active ingredient granules are enclosed within a hard or soft soluble shell.
CAPSULES
are solid dosage forms made up of agglomeration of smaller particles of powders.
GRANULES
are solid dosage forms containing therapeutic ingredients. Small size spherical granules packed into a small bag or pouch packet.
SACHETS
are the solid dosage form that dissolves slowly into the mouth.
LOZENGES
contain a drug along with flavoring and sweetening agents.
LOZENGES
Are the solid dosage forms that are best or most easily absorbed by chewing.
CHEWABLE
_________are those materials which are used in every dosage form.
EXCIPIENTS
_________ are those materials which are used in every dosage form. But it doesn’t have any therapeutic effects or side effects.
EXCIPIENTS
to make the plasticity in the tablet formulation.
BINDERS OR BINDING AGENTS
it helps to maintain the inter-particle bonding strength and to achieve mechanical strength and sometimes for the drug release properties.
BINDERS OR BINDING AGENT
Starch, gelatin, acacia, tragacanth.
NATURAL POLYMERS
4 Natural Polymers:
STARCH
GELATIN
ACACIA
TRAGACANTH
Hydroxypropyl methylcellulose (HPMC), Methyl cellulose, Ethylcellulose, Polyethylene glycol (PEG).
SYNTHETIC POLYMER
Glucose, Sucrose, Sorbitol
SUGAR
3 Sugar:
GLUCOSE
SUCROSE
SORBITOL
Used in tablet preparation. The role of the _______ is protecting the drug from environmental moisture, light, or the acidic environment of the stomach and it also masks the bitter taste of many drugs.
COATING AGENT
3 types of Coating Agents:
SUGAR COATING
FILM COATING
ENTERIC COATING
used to protect the formulation from the attack of microorganisms. Such as bacterial growth, fungus growth, etc.
PRESERVATIVES
Phenol, parabens, aryl and alkyl acids, etc.
PRESERVATIVES
used to giving an attractive outlook for the patients.
COLORING AGENTS
Turmeric, Titanium Dioxide, etc.
NATURAL COLORS
Erythrosine, Tartrazine, etc.
SYNTHETIC COLORS
used in basically chewable tablets. To cover up the unpleasant taste of the tablet or any pharmaceutical formulation.
SWEETENING AGENTS
Sucrose, fructose, etc
SWEETENING AGENTS
constitute a significant proportion of pharmaceutical dosage forms. They serve as carriers for drugs that are topically delivered by way of the skin, cornea, rectal tissue, nasal mucosa, vagina, buccal tissue, urethral membrane, and external ear lining.
SEMI-SOLID DOSAGE FORM
__________ are normally presented in the form of creams, gels, ointments, or pastes.
TOPICSL SEMI-SOLID DOSAGE FORMS
They contain one or more active ingredients dissolved or uniformly dispersed in a suitable base and any suitable excipients such as emulsifiers, viscosity increasing agents, anti microbial agents, antioxidants’, or stabilizing agents.
TOPICAL SEMI-SOLID DOSAGE FORM
contain very limited quantities of a liquid or aqueous phase
SEMI-SOLID DOSAGE FORMS
can be measured by using a simple pH meter or by using a probe-type pH meter.
SURFACE PH
are plastic in behavior hence they retain their shape on application of outside force.
SEMI-SOLID DOSAGE FORM
are homogenous, semi-solid preparations intended for external application to the skin or mucous membrane.
OINTMENTS
They are used as emollients or for the application of active ingredients to the skin for protective, therapeutic, or prophylactic purpose and where a degree of occlusion is desired.
OINTMENTS
Their composition softens but does not melt upon application to the skin. Therapeutically, ______ function as skin protectives and emollients, but they are used primarily as vehicles for the topical application of drug substances.
OINTMENT
usually anhydrous and can absorb only small amounts of water. Typical bases used for their formulation are water-insoluble hydrocarbons such as hard, soft and liquid paraffin, vegetable oil, animal fats, waxes, synthetic glycerides and polyalkyl siloxanes.
HYDROPHOBIC (LIPOPHILIC) OINTMENTS
can absorb large amounts of water. They typically consist of a hydrophobic fatty base in which a w/o agent, such as wool fat, wool alcohols, sorbitan esters, mono glycerides, or fatty alcohols can be incorporated to render them hydrophilic. They may also be w/o emulsions that allow additional quantities of aqueous solutions to be incorporated. Such ointments are used especially when formulating aqueous liquids or solutions.
WATER-EMULSIFYING OINTMENTS
are miscible with water. The bases are usually mixture of liquid and solid polyethylene glycols (macrogols).
HUDROPHILIC OINTMENTS
are homogeneous, semi-solid preparations consisting of opaque emulsion systems.
CREAMS
Their consistency and rheological properties depend on the type of emulsion, either water-in-oil (w/o) or oil-in –water (o/w), and on the nature of the solids in the internal phase. _______ are intended for the application to the skin or certain mucous membranes for protective, therapeutic, or prophylactic purposes, especially where an occlusive effect is not necessary.
CREAMS
are semisolid dosage forms that contain one or more drug substances dissolved or dispersed in a suitable base, usually oil in- water emulsion or aqueous microcrystalline dispersion of long-chain fatty acids or alcohols that are water washable and are cosmetically and aesthetically acceptable.
CREAMS
homogeneous, clear, semi-solid preparation consisting of a liquid phase within a three-dimensional polymeric matrix with physical or sometimes chemical cross linkage by means of suitable gelling agents.
GELS
are semisolid systems that consist of either suspensions of small inorganic particles or large organic molecules interpenetrated by a liquid.
GELS
bases usually consist of liquid paraffin with polyethylene or fatty oils gelled with colloidal silica or aluminium or zinc soaps.
HYDROPHOBIC GELS
bases usually consist of water, glycerol, or propylene glycol gelled with suitable agents such as tragacanth, starch, cellulose derivatives, carboxyvinyl polymers, and magnesium aluminium silicates.
HYDROPHILIC GELS (HYDROGEL)
homogeneous, semi-solid preparations containing high concentrations of insoluble powdered substances (usually not less than 20%) dispersed in a suitable base.
PASTES
The _______ are usually less greasy, more absorptive, and stiffer in consistency than ointments because of the large quantity of powdered ingredients present. Some pastes consist of a single phase, such as hydrated pectin, and others consist of a thick, rigid material that does not flow at body temperature. The pastes should adhere well to the skin. In many cases they form a protective film that controls the evaporation of water.
PASTES
are semisolid dosage forms that contain one or more drug substances incorporated in a base with large proportions of finely dispersed solids.
PASTES
is an ancient form of topical medication also known as a cataplasma.
POULTICES
Poultices is an ancient form of topical medication also known as a ______.
CATAPLASMA
It is a soft mass of vegetable constituents or clay, usually heated before application.
POULTICE
It is prepared by mixing and heating dried, heavy kaolin and boric acid with glycerine. After cooling, the aromatic substances are incorporated with stirring. The product is spread on a dressing and applied hot to the skin.
KAOLIN POULTICE (BP)
