# Presentation: 820744

## Herbert S. Carlin, D.Sc.
Chairman, USP Nomenclature & Labeling Expert Committee

- Herbert S. Carlin, D.Sc.
- Chairman, USP Nomenclature & Labeling Expert Committee

## USP I – XII (1942)
USP XII – XIX (1975)
USP XX NF XV (1980)
USP XXI NF XVI (1985)
USP XXII NF XVII (1990)
USP 23 NF 18 (1995)
USP 24 – 25 NF 19 – 20 (2000 – 2002)

- USP I – XII (1942)
- USP XII – XIX (1975)
- USP XX NF XV (1980)
- USP XXI NF XVI (1985)
- USP XXII NF XVII (1990)
- USP 23 NF 18 (1995)
- USP 24 – 25 NF 19 – 20 (2000 – 2002)

## TITLES IN LATIN
NOMENCLATURE ASSIGNED TO EXECUTIVE COMMITTEE ON SCOPE
ATTENTION PAID TO:
Existing Monograph Titles
Tradition, and
Coordinate with NF published by APhA

- TITLES IN LATIN
- NOMENCLATURE ASSIGNED TO EXECUTIVE COMMITTEE ON SCOPE
- ATTENTION PAID TO:
- Existing Monograph Titles
- Tradition, and
- Coordinate with NF published by APhA

## TITLES IN ENGLISH
COMMITTEE ON SCOPE
SYNONYMS DELETED IN 1965 
Lime Water became Calcium Hydroxide Soln
Silver Nitrate Pencils–Toughen Silver Nitrate
Zinc Gelatin Boot – Zinc Gelatin
1st ROUTE OF ADMINISTRATION added to TITLES [Ophthalmic Solution & Suspension]

- TITLES IN ENGLISH
- COMMITTEE ON SCOPE
- SYNONYMS DELETED IN 1965
- Lime Water became Calcium Hydroxide Soln
- Silver Nitrate Pencils–Toughen Silver Nitrate
- Zinc Gelatin Boot – Zinc Gelatin
- 1st ROUTE OF ADMINISTRATION added to TITLES [Ophthalmic Solution & Suspension]

## NF PURCHASED
COMMITTEE ON SCOPE
REVISION OF VARIOUS TOPICAL TITLES
Aerosol; Aerosol Solution; Solution;
Solution for Irrigation and Powder
ADDITION OF NEW TOPICALS
Emulsions & Magma

- NF PURCHASED
- COMMITTEE ON SCOPE
- REVISION OF VARIOUS TOPICAL TITLES
- Aerosol; Aerosol Solution; Solution;
- Solution for Irrigation and Powder
- ADDITION OF NEW TOPICALS
- Emulsions & Magma

## DRUG NOMENCLATURE COMMITTEE 
The DNC reviewed past decisions and recommended many changes to make the Titles more user-friendly for healthcare providers.
[DRUG] Topical Solution; [DRUG] Gel
[DRUG] Topical Suspension
[DRUG] Ointment; [DRUG] Cream 
DELETE LOTION for [DRUG] corresponding DF

- DRUG NOMENCLATURE COMMITTEE
- The DNC reviewed past decisions and recommended many changes to make the Titles more user-friendly for healthcare providers.
- [DRUG] Topical Solution; [DRUG] Gel
- [DRUG] Topical Suspension
- [DRUG] Ointment; [DRUG] Cream
- DELETE LOTION for [DRUG] corresponding DF

## “[DRUG] Topical Solution and [DRUG] Topical Suspension is the general format..for monograph titles of topical liquid dosage forms.  This nomenclature is intended to displace “Lotion” terminology because Lotion has been criticized as difficult to define, with no physical meaning.....”

- “[DRUG] Topical Solution and [DRUG] Topical Suspension is the general format..for monograph titles of topical liquid dosage forms.  This nomenclature is intended to displace “Lotion” terminology because Lotion has been criticized as difficult to define, with no physical meaning.....”

## “[DRUG] Ointment is a preparation of one or more therapeutic agents in any of the various classes of bases described in chapter <1151> Pharmaceutical Dosage Forms.....”

- “[DRUG] Ointment is a preparation of one or more therapeutic agents in any of the various classes of bases described in chapter <1151> Pharmaceutical Dosage Forms.....”

## “[DRUG] Cream is a topical preparation that is formulated in an emulsion base.  The term Cream preferably pertains to semisolid preparations in water-removable bases that are oil-in-water (o/w) emulsions....”

- “[DRUG] Cream is a topical preparation that is formulated in an emulsion base.  The term Cream preferably pertains to semisolid preparations in water-removable bases that are oil-in-water (o/w) emulsions....”

## “[DRUG] Gel is a formulation in a water-soluble base and may be regarded as a greaseless ointment.....”

- “[DRUG] Gel is a formulation in a water-soluble base and may be regarded as a greaseless ointment.....”

## Joint Meeting of the 1985-1990 & 1990-1995 Drug Nomenclature Committees ratified actions of previous committee.
Publish Stimulus Article “Nomenclature Policies and Recommendations: Review and Current Proposals and Decisions” in January – February 1991 Pharmaceutical Forum.

- Joint Meeting of the 1985-1990 & 1990-1995 Drug Nomenclature Committees ratified actions of previous committee.
- Publish Stimulus Article “Nomenclature Policies and Recommendations: Review and Current Proposals and Decisions” in January – February 1991 Pharmaceutical Forum.

## New Monograph Titles:
PLEDGET:is a vehicle that carry a Topical Solution.
Veterinary
SOLUBLE POWDER
INTRAMAMMARY INFUSION
TOPICAL GEL

- New Monograph Titles:
- PLEDGET:is a vehicle that carry a Topical Solution.
- Veterinary
- SOLUBLE POWDER
- INTRAMAMMARY INFUSION
- TOPICAL GEL

## Three Powder Titles changed to TOPICAL POWDERS
One Water changed to WITCH HAZEL

- Three Powder Titles changed to TOPICAL POWDERS
- One Water changed to WITCH HAZEL

## TWO VETERINARY MONOGRAPHS ADDED
		CONCENTRATE for DIP
		UTERINE INFUSION

- TWO VETERINARY MONOGRAPHS ADDED
- 		CONCENTRATE for DIP
- 		UTERINE INFUSION

## NOMENCLATURE & LABELING EXPERT COMMITTEE
Revisions of current Monographs that relate to Packaging.
Mineral Oil Enema to Mineral Oil, Rectal when suitably packaged.
Light Mineral Oil to Topical Light Mineral Oil when suitably packaged.

- NOMENCLATURE & LABELING EXPERT COMMITTEE
- Revisions of current Monographs that relate to Packaging.
- Mineral Oil Enema to Mineral Oil, Rectal when suitably packaged.
- Light Mineral Oil to Topical Light Mineral Oil when suitably packaged.

## USP 26Monographs

- SKIN SURFACE
- (TOPICALS)
- [310]

## USP 26 TOPICALS

- LIQUIDS [108]
- Emulsions [1]
- Suspensions [6]
- Solutions [78]

- SEMI-SOLIDS [170]
- Collodions [3]
- Creams [70]
- Foams [1]
- Gels [18]
- Ointments [72]
- Pastes [6]

## USP 26 TOPICALS

- SOLIDS
- Gauzes [1]
- Patches [3]
- Powders [24]
- Tapes [1]
- Tablets [3]

## USP 26 Topical Emulsions

- 	[Drug] Cleansing Emulsions [1]
- 	[Drug] Topical Emulsions [0] *
- * [Drug] Lotions [23] may be changes to:
- 			[Drug] Topical Emulsions,
- 			[Drug] Topical Solutions, or
- 			[Drug] Topical Suspensions

## USP 26 Topical Solutions

- [Drug] Cleansing Solutions [1]
- [Drug] Irrigations [6]
- [Drug] Liquid Soaps [1]
- [Drug] Oral/Topical Solutions [2]
- [Drug] Solutions [4]
- [Drug] Tinctures [6] (to Topical Solutions)
- [Drug] Topical Oils [1]
- [Drug] Topical Solutions [44] *

## USP 26 Topical Suspensions

- [Drug] Shampoos [1]
- [Drug] Topical Suspensions [5] *

## USP 26 Topical Semi-Solids

- [Drug] Collodions [3]
- [Drug] Creams [70]
- [Drug] Gels [15]
- [Drug] Topical Gels [3]
- [Drug] Topical Foams [1]
- [Drug] Ointments [72]
- [Drug] Pastes [6]

## USP 26 Topical Solids

- POWDERS
- 	[Drug] Topical Aerosol [12]
- 	[Drug] for Topical Solution [2]
- 	[Drug] Dusting Powders [1]
- 	[Drug] Topical [2]
- 	[Drug] Topical Powders

## USP 26 Topical Solids

- PATCHES
- 	[Drug] Film [1]
- 	[Drug] Plasters [1]
- 	[Drug] Pledgets [1]

- GAUZES
- 	[Drug] Gauzes [1]

## USP 26 Topical Solids

- TABLETS
- 	[Drug]  Tablets for
- 	Topical Solutions [3]

- TAPES
- 	[Drug] Tapes [1]

## TAXONOMY ANDGLOSSARY 

- USP’S EXPERT COMMITTEES ON PHARMACEUTICAL DOSAGE FORMS (PDF) BIOPHARMACEUTICS (BPC) and      NOMENCLATURE and LABELING (NL) are WORKING TOGETHER TO PREPARE A TAXONOMY AND GLOSSARY OF OFFICIAL DOSAGE FORMS.
- A “STIMULUS ARTICLE” WILL SOON BE PUBLISHED IN PF.

## Categories of Pharmaceutical Dosage Forms

**USP Expert Committee on Pharmaceutical Dosage Forms **

**FIRST TIER**

- Delineated by the tissues to which the active is first delivered by the dosage form.

**SECOND TIER**

**A “Taxonomy”  Proposal**

- The criterion for this grouping is based on the general type of dosage form involved.

**THIRD TIER**

- Individual dosage forms grouped depending on the release pattern of the active.

**NOTE:**** In some dosage forms it may be advisable to preface titles with a descriptor. For example “Topical Cream”, “Vaginal Insert” or “Otic Solution”.**

**The taxonomy charts given here only incorporate dosage forms that are actually named in monogrphs of the USP/NF.**

## Categories of Pharmaceutical Dosage Forms

**Categories of Pharmaceutical Dosage Forms**

**nasal**

**otic**

**ophth-**

**vaginal**

**FIRST TIER CATEGORY****	****	**_**DELIVERY ROUTE**_**  [i.e. based on tissues to which active delivered]**

**                                                           ****6**

**                                                           ****6**

**                                                           ****7**

**SECOND TIER CATEGORY       **_**DOSAGE FORM**_** [i.e. based on the **_**general**_** type of dosage form]**

**Mucosal   Membranes**

***[      Indicates page number of second tier]***

**oral**

**4**

**3**

**rectal**

**Skin surface**

**                                                           ****8**

**                                                           ****9**

**topical**

**dermal**

**trans-**

**almic**

**urethral**

**4**

**                                                           ****7**

**IV**

**IM**

**etc**

**SC**

**oro-**
**pharyngeal**

**                                                           ****6**

**Gastro-intestinal  Tract**

**lungs**

**                                                           ****10**

**Tissues or  Body  Fluids**
**[by injection]**

**                                                           ****5**

## Categories of Pharmaceutical Dosage Forms

**solutions**

**solids**

-  [Dermal]

**semi-solids**

**                                                           ****8**

**ointments**

**patches**

** ****plasters **

**powders**

**liquids**

**aerosols**

**suspensions**

**films**

**pastes**

**gauzes**

**foams**

***[NOTE: May preface titles with “topical”, e.g. “Topical cream”]***

**Categories of Pharmaceutical Dosage Forms**

**Skin surface**

**topical**

**SECOND TIER CATEGORY       **_**DOSAGE FORM**_** [i.e. based on the **_**general**_** type of dosage form]**

**THIRD TIER CATEGORY      TYPE OF RELEASE  [i.e. based on the RELEASE PATTERN OF THE ACTIVE]**

**emulsions**

**collodions**

**w/o**

**creams**

**tapes**

**o/w**

**gels**

**sticks**

## Categories of Pharmaceutical Dosage Forms

**Modified release**

**Extended release**

**Delayed release**

**Orally disintegrating**

**Pulsatile release**

**Targeted release**

*[Slower rate]*

*[Delayed onset]*

*[Specific organ/tissue]*

*[Faster rate than conventional]*

**Categories of Pharmaceutical Dosage Forms**

**THIRD TIER CATEGORY    ****TYPE OF RELEASE  [i.e. based on the RELEASE PATTERN OF THE ACTIVE]**

**(immediate release)**

**[possible common Third Tier categorization] **

*[Fractions released at time intervals]*

**Orally dispersing**

*[Faster rate than conventional]*

- * **Use of “conventional release” is encouraged.**
- The term “immediate” has been widely used in place of the less misleading and more appropriate term “conventional” with reference to dosage form nomenclature.

*****

## CONCLUSIONS

- OVER THE YEARS, USP HAS CONVERTED OFFICIAL TITLES OF DOSAGE FORMS:
- FROM THOSE INDICATING THE FORMULATION AND/OR METHOD OF MANUFACTURE TO THOSE DESCRIBING THE FINISHED PRODUCT IN TERMS BELIEVED TO BE MORE USEFUL TO THE PRESCRIBER, DISPENSER AND THE PATIENT.

## CONCLUSIONS

- BY ADDING THE ROUTE OF ADMINISTRATION TO THE TITLE. I.E. OPHTHALMIC; OTIC; NASAL; VAGINAL; RECTAL and TOPICAL.
- IT SHOULD BE NOTED THAT THE TYPE OF PACKAGING AND LABELING MAY BECOME A MORE SIGNIFICANT PLAYER IN DESIGNING DOSAGE FORM TITLES.

## NOTE ON LOTIONS

- THE DELETION OF LOTION AS A TITLE  IN FAVOR OF TOPICAL SUSPENSION, SOLUTION AND EMULSION HAS BEEN PLACED ON HOLD BY THE USP NOMENCLATURE & LABELING EXPERT COMMITTEE UNTIL THE USP AND FDA HAVE REVIEWED THE MATTER.
- THIS MEETING IS A IMPORTANT IN THE COMMITTEE’S FINAL DECISION.