MODULE NO.1 INTRODUCTION TO DRUGS AND PHARMACEUTICAL FORMULATION CONSIDERATIONS Flashcards by Maki Sampaga

WHAT IS A DRUG?
⦿Is an agent intended for use in the;

✔Diagnosis
✔Mitigation
✔Treatment
✔Cure
✔Prevention
of disease in humans or in other animal (DiMiTreCuP)

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ANO ANG GAMOT??

⦿G - Inhawa (mitigation)
⦿A - lisin ang sanhi (cure)
⦿M - aibalik sa normal (treatment)
⦿O (U) - miwas sa sakit (prevention)
⦿T - ukuyin ang dahilan (diagnosis)

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⦿Also known as Pharmaceuticals
⦿Are preparations designed to contain a specified quantity of medication for ease and accuracy of dosage administration

DOSAGE FORMS

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A PHARMACEUTICAL FORMULATION CONTAINS;

⦿ACTIVE INGREDIENTS
⦿NON-ACTIVE INGREDIENTS

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 Active Pharmaceutical Ingredients (API)
 Pharmacologically active
 Therapeutic ingredients

⦿ACTIVE INGREDIENTS

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 Inert
 Inactive ingredients
 Additive
 Excipients

Give the formulation its unique composition and characteristic physical appearance

⦿NON-ACTIVE INGREDIENTS

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◼According to USP, it holds the article and is or maybe in direct contact with the article
◼immediate container (the one that is in direct contact with the article at all times)
◼closure

CONTAINER

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the one that is in direct contact with the article at all times

immediate container

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CONTAINER TYPES o According to

Their Ability to Protect their Contents from External Conditions

o Well-closed
o Tightly-closed
o Hermetic container
o Light-resistant
o Child-resistant
o Tamper-proof container

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CONTAINER TYPES

According to Content or Capacity

o Single Dose
o Multiple Doses

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It protects the content from
extraneous solids and from loss of the article under ordinary conditions of handling, shipment, storage and distribution

WELL-CLOSED CONTAINER

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It protects the contents from contamination by extraneous liquids, solids or vapors, from loss of the article and from efflorescence, deliquescence or evaporation under the ordinary or customary conditions of handling, shipment, storage and, distribution and is capable of tight re-closure

TIGHTLY-CLOSED CONTAINER

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⦿It is impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage and distribution

HERMETIC CONTAINER

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⦿It provides protection from the degradative effects of light by reducing light transmission

LIGHT-RESISTANT CONTAINER

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⦿Also known as “amber” bottle

LIGHT-RESISTANT CONTAINER

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LIGHT-RESISTANT CONTAINER

Ultraviolet absorbers added to decrease the transmission of short ultraviolet rays

⦿Light resistant opaque plastic

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LIGHT-RESISTANT CONTAINER

⦿USP standard on limit if light transmission between wavelengths??

290-450nm

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⦿Intended for injection or parenteral preparation

HERMETIC CONTAINER

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CHILD-RESISTANT CONTAINER

+ Four basic designs

⚫Align the arrows
⚫Press down and turn
⚫Squeeze and turn
⚫Latch top

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A container that is significantly difficult for children to open or to obtain a harmful amount of its contents within a measurable time and that is not difficult for normal adults to use properly

CHILD-RESISTANT CONTAINER

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⦿ Specially for children 5 years and below

CHILD-RESISTANT CONTAINER

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A packaging that has one or more indicators or barriers to entry which if breached or missing, can reasonably be expected to provide visible evidence that tampering has occurred

TAMPER-EVIDENT CONTAINER

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◉Film wrapper
◉Blister or strip pack
◉Bubble pack
◉Shrink seal or band
◉Foil, paper or plastic pouch

TAMPER-EVIDENT CONTAINER

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◉Bottle seal (inner cap)
◉Tape seal
◉Breakable cap
◉Sealed Tube
◉Sealed carton
◉Aerosol container

TAMPER-EVIDENT CONTAINER

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One that holds a quantity of drug intended as a single dose and when opened cannot be resealed with assurance that sterility has been maintained

Single Dose

◼Examples: ð Ampules ð Prefilled syringes or cartidges

Single Dose

One that contains more than a single dose of the medication and permits the withdrawal of successive portions without changing the strength or endangering the quality or purity of the remaining portion

MULTIPLE DOSE

◼Examples: ð Vials

MULTIPLE DOSE

CONTAINER MATERIALS

1. Glass 2. Plastic

- highly-resistant borosilicate glass - Parenteral products - Most resistant

Type I Glass

- treated soda-lime glass - Parenteral products

Type II Glass

- soda lime glass - Parenteral products

Type III Glass

- general purpose soda-lime glass - Other preparations

Type IV or NP Glass

PLASTIC CONTAINERS Plastic materials used are:

⦿ polyvinyl chloride (PVC) ⦿ polyethylene terephthalate (PET) ⦿ amorphous polyethylene terephthalate glycol (APET) ⦿ polyethylene terephthalate glycol (PETG)

have excellent transparency and luster can be sterilized with gamma radiation

APET and PETG

- rigid and has good clarity; useful in blister packaging of tablets and capsules - not suitable when gamma sterilization is required

⦿ polyvinyl chloride

CONTAINER MATERIALS ⦿Plastic ◼Advantages

ð Lightness in weight ð Resistance to impact ð Versatility in container design and consumer acceptance ð Consumer preference for plastic squeeze bottles ð Popularity of blister packaging and unit-dose dispensing

CONTAINER MATERIALS ⦿Plastic ◼Disadvantages

ð Permeability of the container to atmospheric oxygen and to moisture vapor ð Leaching of the constituent of the container to the internal contents ð Absorption of drugs from the contents to the container ð Transmission of light through the container ð Alteration of the container upon storage (deformity)

◼Label on immediate container ◼Package inserts ◼Company literature ◼Advertising and promotional materials

LABELING

⦿With Rx symbol, or the Legend: ……… Act prohibits dispensing without prescription (#6)

PRESCRIPTION DRUG LABEL

⦿For Controlled substances - The statement: “Warning - May be habit forming" (#12)

PRESCRIPTION DRUG LABEL

⦿Statement of pharmacologic category; No Rx symbol

OTC LABEL

PRESCRIPTION DRUG LABEL

◼Nonproprietary and Proprietary name of the drug ◼Name and address of manufacturer ◼Dosage strength or potency ◼Type of dosage form

PRESCRIPTION DRUG LABEL

◼Net content ◼Prescription logo and Legend statement ◼Label reference to see the accompanying package insert ◼Special storage instructions

PRESCRIPTION DRUG LABEL

OTC DRUG LABEL

◼Storage conditions ◼Description of tamper-evident feature ◼Lot number and expiration date

The label should contain: “This statement has not been evaluated by the FDA. The product is not intended to diagnose, treat, cure or prevent any disease”

DIETARY SUPPLEMENT

- should state specific parts of the plant used (Supplement Facts)

HERBAL PRODUTS

USP verified program NSF Certification Program Consumer Laboratories

PRODUCT STANDARDIZATION

assurance of product safety but not guarantee effectiveness

SEAL

ð Any temperature not exceeding 8 degrees Celcius ⚫Refrigerator (2 to 8C) ⚫Freezer (-25 to -10C)

Cold Temperature

2 to 8C

Refrigerator

-25 to -10C

Freezer

Any temperature between 8 to 15C

Cool Temperature

The temperature prevailing in a working area

Room Temperature

Temperature between 20 to 25C or sometimes 15 to 30C

Controlled Room Temperature

Warm Temperature

Any temperature between 30 to 40C

Excessive Heat

Any temperature above 40C

◼Protection from Freezing Risks of freezing:

breakage of the container; loss of potency/strength; destructive alteration of the dosage form

Treat ?

Symptoms

Cure ?

Disease

No therapeutical reaction

Inert

LADMERT

Liberation Absorption Distribution Metabolism Excretion Response Toxicity

Pharmaceuticals; study of

Liberation, pharmaceutics

Main ingredient in a drug causes main effect in body

API - active pharmaceutical ingredient

API + excipient ()

Syrup base

Direct contact w/ drug Ex. Syrup bottle

Immediate container

Prescription drug is also called

Ethical drug, legend drug

No direct contact w/ drug Ex. Box of syrup medicine

Secondary container

Can be melted with gamma

PVC

Examples are IV AND IM - sterile like bodily fluids - paraenteral

Parenteral

Box label Package insert

Secondary label

business name

Propriety name

Generic name is ___ the box

Inside

Used for storage of pfizer vaccine (4-8 hrs to use)

Ultrafreezer

Vaccine

Prevention

MODULE NO.1 INTRODUCTION TO DRUGS AND PHARMACEUTICAL FORMULATION CONSIDERATIONS Flashcards

(79 cards)