(DDS LEC) INTRO TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM

According to _______________:

__________ are:

• articles recognized in the official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them;

• article intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man, or other animals

• articles (other than food) intended to affect the structure or any function of the body of human or other animals; and

• articles intended for use as a component of any articles specified in any of the previously mentioned definitions

RA 3720
Drugs

____________________________

• created by Pharmaceutical Society in the US

• ______ pages containing _______ monographs

United States Pharmacopoeia
272
536

_________________ = ________(drug); _______(make), established in _____ due to several key reasons:

1. standardization of medicine

2. public heath and safety

3. professionalization of pharmacy and medicine

Pharmacopoeia
pharmakon
poein
1820

___________________ is a compendium of standards for pharmaceutical ingredients, excipients and dosage forms

• _____________________________ (1888)

• Title was changed to _______________ in 1906 when the ________________ was signed by ______________________ and considered a national compendia

• In 1975, the _____________________ bought NF, unifying the two compendia

National formulary
National formulary of Unofficial Preparations
National formulary
Pure food and drug act
Theodore Roosevelt
USP Convention Inc.

___________________ is a factual, scientific document that provides the standards for the identity, strength, purity, and consistency of a specific drug substance, dosage form or excipient

Monograph

What are the 6 parts of a Monograph?

1. -

2. -

3. -

4. -

5. -

6. -

Identification
Assay
Purity
Quality
Packaging and Storage
Labeling

______________ states the test that confirms the identity of your substance or product

Identification

______________ includes methods to determine potency and strength

assay

______________ will tell you how to test for impurities or contaminants

Purity

_________________ will tell you the required pH of the substance you’re testing, the dissolution profile, and stability

Quality

______________________

• “What is its physical form?”

• Means of administering drugs as formulated preparations

• combination of a drug entity(active pharmaceutical ingredient) and drug additives (excipients)

dosage forms

______________________ is the process of making a drug entity ready for use.

answers the question “What formulation was it made?”

Pharmaceutical preparations

______________________ is the finished dosage form that contains a drug entity, generally, but not necessarily, in association with inactive ingredients

answers the question “What is the finished medical product available in the market?”

Drug product

_________________________ is any chemical entity that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or function of the body of man or other animals

Active pharmaceutical ingredient

_________________ or ______________

• any component other than the active pharmaceutical ingredient in a dosage form

• INACTIVE INGREDIENT

• provides the drug or active therapeutic agent in a form suitable for administration

Excipients
Drug additives

Importance of Dosage forms:

1. Protect the drug entity from the destructive influences of ________________ or _________ and _____________ after oral administration

2. Conceal the unpleasant _______ or _________ of a drug substance

3. Provide an ideal preparation to _________ a drug entity into the body

4. Provide ________-controlled drug action

atmospheric oxygen
humidity
gastric acid
taste
odor
transport
rate

______________________ is the method designed to transport a pharmaceutical compound into the body in a controlled and efficient manner to achieve its desired therapeutic effect

• You need to get the drug to the right place, in the right amount, at the right rate, and for the appropriate duration to produce its therapeutic effects

Drug delivery system

What are the 3 under Intra vascular?

1. -

2. -

3. -

Intravenous
Intraarterial
Intracardiac

What are the 5 under extravascular?

1. -

2. -

3. -

4. -

5. -

Oral
Buccal
Sublingual
Rectal
Parenteral

_____________is made to order while ______________ is a large-scale production wherein it is inteded to be used by the community

Compounding
Manufacturing

_____________________ is the preparation, mixing, assembling, packaging, or labelling of a drug or device as a result of a practitioner’s prescription or medication order

• also includes the preparation of drugs or devices in anticipation of prescriptions or medication orders based on routine, regularly observed prescribing patters

• __________________ compounding

• practitioner-patient-pharmacist relationships

Compounding
Extemporaneous

Good compounding practices

• _______________________

- design and maintenance of facilities

- compounding equipment is of appropriate design and size and suitable for intended use

- measure, transfer, and handle medications

- prescription balance, spatula, mortar and pestle, ointment slabs, graduated cylinder

Compounding environment

Good compounding practices

• ______________________

- packaging, sterility, stability criteria, guidelines for assigning beyond-use dates

Stability of compounded preparations

what are the 3 types of pestle?

1. -

2. -

3. -

glass
wedgewood
porcelain

_________ is a type of pestle that is used for liquid and oily substances

glass

___________ is the type of pestle used for grinding due to its rough surface

wedgewood

_________________ is a type of pestle used for smoother blending of powders

porcelain