Identification

Summary

Tuberculin purified protein derivative is a purified protein used in the Mantoux test for Mycobacterium tuberculosis testing.

Brand Names
Aplisol, Tubersol
Generic Name
Tuberculin purified protein derivative
DrugBank Accession Number
DB11601
Background

Tuberculin Purified Protein Derivative (PPD) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The diagnostic test is commonly referred to as the Mantoux test which serves to minimize the risk of transmission of infection with Mycobacterium tuberculosis through early diagnosis and appropriate therapeutic intervention. The purified protein fraction is isolated from culture media filtrates of a human strain of Mycobacterium tuberculosis. It is included in the World Health Organization's List of Essential Medicines.

Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Other protein based therapies
Protein Chemical Formula
Not Available
Protein Average Weight
Not Available
Sequences
Not Available
Synonyms
  • Mycobacterium tuberculosis purified protein derivative
  • Purified protein derivative of tuberculin
  • Tuberculin PPD
  • Tuberculin, purified protein derivative
  • Tuberculin,purified protein derivative
  • Tuberculina PPD
  • Tuberculinum
External IDs
  • DRG-0133

Pharmacology

Indication

Indicated as a diagnostic agent in Mantoux Test used to detect infection with Mycobacterium tuberculosis.

Pharmacology
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Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
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Pharmacodynamics

It is intradermally administered to facilitate detection of active tuberculosis caused by Mycobacterium tuberculosis. Tuberculin PPD is an inactivated purified protein fraction obtained from human strain of Mycobacterium tuberculosisand antigen that induces a delayed hypersensitivity response after few hours following administration. When the person has already acquired the tuberculin antigen, the immune response is stimulated to produce antigen-specific T cells that circulate in the bloodstream for up to several months and years. Clinically, a delayed hypersensitivity reaction to tuberculin is a manifestation of previous infection with M tuberculosis or a variety of non-tuberculosis bacteria. In most cases sensitization is induced by natural mycobacterial infection or by vaccination with BCG Vaccine. The antigen causes, pain, edema and infiltration of immune cells in the injection area.

Mechanism of action

When exposed to M. tuberculosis antigen, the sensitization initiates in the regional lymph nodes where T lymphocytes proliferate in response to the antigenic stimulus to give rise to specifically sensitized lymphocytes which may exist in the circulation up to many years. Antigen is presented to T cells by being ingested by antigen presenting cells (APC), which then present it on their surface to lymphocytes in combination with various MHC molecules once they reach local lymph nodes 4. Tuberculin PPD most likely interacts with toll-like receptor 2 expressed on APCs that initiates an inflammatory response. Subsequent restimulation of these sensitized lymphocytes with the same or a similar antigen, such as the intradermal injection of tuberculin PPD, evokes a local reaction mediated by these cells. This reaction is referred to as a delayed-type hypersensitivity response that includes vasodilation, edema, and the infiltration of lymphocytes, basophils, monocytes, and neutrophils into the site of antigen injection. The sensitized antigen-specific T lymphocytes proliferate and release lymphokines, which mediate the accumulation of other cells at the site 5. In vitro studies show that Tuberculin PPD promotes the upregulation of vascular endothelial growth factor (VEGF) expression in T lymphocytes through major histocompatibility (MHC) class II interaction with CD4+ T lymphocyte interaction 3. The reactions are evident after 5-6 hours following administration.

TargetActionsOrganism
AToll-like receptor 2
ligand
Humans
Absorption

Not Available

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism
Not Available
Route of elimination

Not Available

Half-life

Not Available

Clearance

Not Available

Adverse Effects
Adverseeffects
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Toxicity

Some adverse effects at the injection site include pain, discomfort, pyrexia, and erythema, rash, hemorrhage, hematoma and rarely ulcer and necrosis. Other unwanted effects include severe hypersensitivity reactions, dyspnea, generalized rash and syncope.

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
No interactions found.

Products

Products2
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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
AplisolInjection5 [iU]/0.1mLIntradermalA-S Medication Solutions2008-04-25Not applicableUS flag
AplisolInjection5 [iU]/0.1mLIntradermalPar Pharmaceutical2008-04-25Not applicableUS flag
AplisolInjection5 [iU]/0.1mLIntradermalTYA Pharmaceuticals2014-04-25Not applicableUS flag
AplisolInjection5 [iU]/0.1mLIntradermalREMEDYREPACK INC.2013-11-262017-11-29US flag
Tuberculin Ppd (mantoux)Liquid250 tub / 0.1 mLIntradermalAventis Pasteur Limited1975-12-312001-07-19Canada flag
Tuberculin Ppd (mantoux)Liquid1 tub / 0.1 mLIntradermalAventis Pasteur Limited1975-12-312001-07-19Canada flag
TubersolInjection, solution5 [iU]/0.1mLIntradermalPhysicians Total Care, Inc.1956-08-152013-06-30US flag
TubersolInjection, solution5 [iU]/0.1mLIntradermalA-S Medication Solutions1956-08-15Not applicableUS flag
TubersolInjection, solution5 [iU]/0.1mLIntradermalPhysicians Total Care, Inc.1956-08-15Not applicableUS flag
TubersolInjection, solution5 [iU]/0.1mLIntradermalA-S Medication Solutions1956-08-15Not applicableUS flag

Categories

Drug Categories
Chemical TaxonomyProvided by Classyfire
Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available
Affected organisms
Not Available

Chemical Identifiers

UNII
I7L8FKN87J
CAS number
92129-86-7

References

General References
  1. Yang H, Kruh-Garcia NA, Dobos KM: Purified protein derivatives of tuberculin--past, present, and future. FEMS Immunol Med Microbiol. 2012 Dec;66(3):273-80. doi: 10.1111/j.1574-695X.2012.01002.x. Epub 2012 Aug 1. [Article]
  2. Prasad TS, Verma R, Kumar S, Nirujogi RS, Sathe GJ, Madugundu AK, Sharma J, Puttamallesh VN, Ganjiwale A, Myneedu VP, Chatterjee A, Pandey A, Harsha H, Narayana J: Proteomic analysis of purified protein derivative of Mycobacterium tuberculosis. Clin Proteomics. 2013 Jul 19;10(1):8. doi: 10.1186/1559-0275-10-8. [Article]
  3. Matsuyama W, Kubota R, Hashiguchi T, Momi H, Kawabata M, Nakagawa M, Arimura K, Osame M: Purified protein derivative of tuberculin upregulates the expression of vascular endothelial growth factor in T lymphocytes in vitro. Immunology. 2002 May;106(1):96-101. [Article]
  4. 6. (2012). In Rang and Dale's Pharmacology (7th ed., pp. 82-84). Edinburgh: Elsevier/Churchill Livingstone. [ISBN:978-0-7020-3471-8]
  5. Tubersol (Tuberculin Purified Protein Derivative) product information [Link]
  6. World Health Organization Model List of Essential Medicines (19th List) [Link]
PubChem Substance
347911212
RxNav
8948
Wikipedia
Tuberculin
FDA label
Download (138 KB)
MSDS
Download (59 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
3CompletedDiagnosticTuberculosis (TB)2
3Not Yet RecruitingTreatmentVerruca Vulgaris1
2CompletedDiagnosticHansen's Disease1
2CompletedDiagnosticTuberculosis (TB)3
2Unknown StatusNot AvailableTuberculosis Identification1
2Unknown StatusDiagnosticTuberculosis (TB)2
2, 3CompletedDiagnosticTuberculosis (TB)1
0Not Yet RecruitingBasic ScienceHealthy Subjects (HS) / Latent Tuberculosis Infection (LTBI)1
Not AvailableCompletedScreeningHuman Immunodeficiency Virus (HIV) Infections / Tuberculosis (TB)1
Not AvailableWithdrawnBasic ScienceAtopic Dermatitis1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
InjectionIntradermal5 [iU]/0.1mL
Injection, powder, for suspension
Injection, powder, lyophilized, for solutionParenteral5 IU
Injection, powder, lyophilized, for solutionParenteral10 IU
LiquidIntradermal1 tub / 0.1 mL
LiquidIntradermal250 tub / 0.1 mL
InjectionIntradermal
InjectionSubcutaneous0.4 mcg
Injection, solutionIntradermal
SolutionIntradermal50 UT
Injection, solutionIntradermal5 [iU]/0.1mL
SolutionIntradermal5 tub / 0.1 mL
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

Targets

Drugtargets2
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Kind
Protein
Organism
Humans
Pharmacological action
Yes
Actions
Ligand
General Function
Triacyl lipopeptide binding
Specific Function
Cooperates with LY96 to mediate the innate immune response to bacterial lipoproteins and other microbial cell wall components. Cooperates with TLR1 or TLR6 to mediate the innate immune response to ...
Gene Name
TLR2
Uniprot ID
O60603
Uniprot Name
Toll-like receptor 2
Molecular Weight
89836.575 Da
References
  1. Biyikli OO, Baysak A, Ece G, Oz AT, Ozhan MH, Berdeli A: Role of Toll-Like Receptors in Tuberculosis Infection. Jundishapur J Microbiol. 2016 Sep 14;9(10):e20224. eCollection 2016 Oct. [Article]
  2. Strapagiel D, Kasztalska K, Druszczynska M, Kowalewicz-Kulbat M, Vrba A, Matusiak A, Chmiela M, Rudnicka W: Monocyte response receptors in BCG driven delayed type hypersensitivity to tuberculin. Folia Histochem Cytobiol. 2008;46(3):353-9. doi: 10.2478/v10042-008-0044-1. [Article]

Drug created at May 24, 2016 22:49 / Updated at December 01, 2021 01:05