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Chemistry

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Also known as: Serax, Tazepam, 604-75-1, Adumbran, Droxacepam, Zaxopam

Molecular Formula

C₁₅H₁₁ClN₂O₂

Molecular Weight

286.71 g/mol

InChI Key

ADIMAYPTOBDMTL-UHFFFAOYSA-N

FDA UNII

6GOW6DWN2A

A benzodiazepine used in the treatment of anxiety, alcohol withdrawal, and insomnia.

Oxazepam is a Benzodiazepine.

1 2D Structure

Oxazepam

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

7-chloro-3-hydroxy-5-phenyl-1,3-dihydro-1,4-benzodiazepin-2-one

2.1.2 InChI

InChI=1S/C15H11ClN2O2/c16-10-6-7-12-11(8-10)13(9-4-2-1-3-5-9)18-15(20)14(19)17-12/h1-8,15,20H,(H,17,19)

2.1.3 InChI Key

ADIMAYPTOBDMTL-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1=CC=C(C=C1)C2=NC(C(=O)NC3=C2C=C(C=C3)Cl)O

2.2 Other Identifiers

2.2.1 UNII

6GOW6DWN2A

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Adumbran

2. Serax

3. Tazepam

2.3.2 Depositor-Supplied Synonyms

1. Serax

2. Tazepam

3. 604-75-1

4. Adumbran

5. Droxacepam

6. Zaxopam

7. Ansioxacepam

8. Anxiolit

9. Durazepam

10. Nesontil

11. Noctazepam

12. Praxiten

13. Psiquiwas

14. Quilibrex

15. Aplakil

16. Astress

17. Bonare

18. Drimuel

19. Isodin

20. Limbial

21. Murelax

22. Pacienx

23. Propax

24. Rondar

25. Sedigoa

26. Serenid

27. Serepax

28. Seresta

29. Serpax

30. Sobril

31. Vaben

32. Hi-long

33. Azutranquil

34. Psicopax

35. Sigacalm

36. Uskan

37. (rs)-oxazepam

38. Nortemazepam

39. Nozepam

40. Tarchomin

41. (+-)-oxazepam

42. Serenid-d

43. Oxazepamum

44. Oxozepam

45. Tacepam

46. Quen

47. Tranquo-buscopan-wirkstoff

48. Wy-3498

49. Z10-tr

50. Ro 5-6789

51. Cb 8092

52. 2h-1,4-benzodiazepin-2-one, 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-

53. 7-chloro-3-hydroxy-5-phenyl-1,3-dihydro-2h-1,4-benzodiazepin-2-one

54. Oxazepam Civ

55. 7-chloro-3-hydroxy-5-phenyl-1,3-dihydro-1,4-benzodiazepin-2-one

56. 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2h-1,4-benzodiazepin-2-one

57. 6gow6dwn2a

58. Nsc-169448

59. Chebi:7823

60. Abboxapam

61. Lederpam

62. Alepam

63. Oxanid

64. Anxiolit Retard

65. Oxa-puren

66. J3.308a

67. N-desmethyltemazepam

68. Ossazepam [dcit]

69. Ncgc00159323-02

70. Ncgc00159323-03

71. Ossazepam

72. Oxazipam

73. Dsstox_cid_1087

74. Oxazepamum [inn-latin]

75. Dsstox_rid_75934

76. Dsstox_gsid_21087

77. Z 10 Tr

78. Wy 3498

79. Cas-604-75-1

80. Ccris 488

81. Serax (tn)

82. Hsdb 3140

83. Einecs 210-076-9

84. Unii-6gow6dwn2a

85. Nsc 169448

86. Oxazepam (jan/usp/inn)

87. Dea No. 2835

88. 1,3-dihydro-7-chloro-3-hydroxy-5-phenyl-2h-1,4-benzodiazepin-2-one

89. Oxazepam [usan:usp:inn:ban:jan]

90. Oxazepam [hsdb]

91. Oxazepam [iarc]

92. Oxazepam [usan]

93. Oxazepam [inn]

94. Oxazepam [jan]

95. Oxazepam [mi]

96. Oxazepam [vandf]

97. (.+/-.)-oxazepam

98. Oxazepam [mart.]

99. Chembl568

100. Oxazepam [who-dd]

101. (+-)-7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2h-1,4-benzodiazepin-2-one

102. Oprea1_501459

103. Schembl27435

104. Temazepam Impurity, Oxazepam-

105. Divk1c_000986

106. Oxazepam [orange Book]

107. Oxazepam Civ [usp-rs]

108. Gtpl7253

109. Oxazepam [ep Monograph]

110. Dtxsid1021087

111. Niosh/df2371850

112. Oxazepam [usp Monograph]

113. Adimayptobdmtl-uhfffaoysa-

114. Bdbm85031

115. Hms503e13

116. Kbio1_000986

117. Oxazepam 0.1 Mg/ml In Methanol

118. Oxazepam 1.0 Mg/ml In Methanol

119. Ninds_000986

120. Nsc_4616

121. Tox21_111572

122. Tox21_112819

123. Tox21_200700

124. Tox21_303501

125. 1,3-dihydro-7-chloro-3-hydroxy-5-phenyl-3h-1,4-benzodiazepin-2-one

126. 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2h-1,4-benzodiazepine-2-one

127. 7-chloro-1,4-benzodiazepine-2-one

128. Mfcd00057903

129. Nsc169448

130. Akos016347293

131. Db00842

132. 2h-1,4-benzodiazepin-2-one, 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-, (+-)-

133. Idi1_000986

134. Wln: T67 Gmv Jn Ihj Cg Iq Kr

135. Ncgc00159323-04

136. Ncgc00257352-01

137. Ncgc00258254-01

138. Cas_604-75-1

139. Temazepam Impurity B [ep Impurity]

140. Df23718500

141. C07359

142. D00464

143. 604o751

144. Q412299

145. Sr-01000942251

146. 2h-1, 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-

147. 7-chloro-5-phenyl-3h-1,4-benzodiazepine-2,3-diol

148. Sr-01000942251-1

149. Temazepam Impurity, Oxazepam- [usp Impurity]

150. 7-chloro-3-hydroxy-5-phenyl-1,4-benzodiazepin-2-one

151. Oxazepam Solution, Drug Standard, 1.0 Mg/ml In Methanol

152. Oxazepam, European Pharmacopoeia (ep) Reference Standard

153. 3-hydroxy-1,3-dihydro-7-chloro-5-phenyl-2h-1,4-benzodiazepin-2-one

154. 3-hydroxy-5-phenyl-7-chloro-2,3-dihydro-1h-1,4-benzodiazepin-2-one

155. 3h-1,4-benzodiazepin-2-one, 1,3-dihydro-7-chloro-3-hydroxy-5-phenyl-

156. 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-1,4 [2hl-benzodiazepin-2-one

157. 7-chloro-3-hydroxy-5-phenyl-1,3-dihydro-benzo[e][1,4]diazepin-2-one

158. 7-chloro-3-hydroxy-5-phenyl-2,3-dihydro-1h-1,4-benzodiazepin-2-one

159. (+/-)-7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2h-1,4-benzodiazepin-2-one

160. 2h-1,4-benzodiazepin-2-one, 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-, (+/-)-

161. 7-chloro-3-hydroxy-5-phenyl-1,3-dihydro-2h-benzo[e][1,4]diazepin-2-one

162. Oxazepam For Peak Identification, European Pharmacopoeia (ep) Reference Standard

163. Oxazepam Solution, 1 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

2.4 Create Date

2004-09-16

3 Chemical and Physical Properties

Molecular Formula	C₁₅H₁₁ClN₂O₂
Molecular Weight	286.71 g/mol
XLogP3	2.2
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	1
Exact Mass	286.0509053 g/mol
Monoisotopic Mass	286.0509053 g/mol
Topological Polar Surface Area	61.7 Å²
Heavy Atom Count	20
Formal Charge	0
Complexity	407
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Oxazepam
PubMed Health	Oxazepam (By mouth)
Drug Classes	Antianxiety
Drug Label	Oxazepam is the first of a chemical series of compounds, the 3-hydroxybenzodiazepinones. A therapeutic agent providing versatility and flexibility in control of common emotional disturbances, this product exerts prompt action in a wide variety of dis...
Active Ingredient	Oxazepam
Dosage Form	Capsule
Route	Oral
Strength	30mg; 15mg; 10mg
Market Status	Prescription
Company	Sandoz; Actavis Elizabeth

2 of 2
Drug Name	Oxazepam
PubMed Health	Oxazepam (By mouth)
Drug Classes	Antianxiety
Drug Label	Oxazepam is the first of a chemical series of compounds, the 3-hydroxybenzodiazepinones. A therapeutic agent providing versatility and flexibility in control of common emotional disturbances, this product exerts prompt action in a wide variety of dis...
Active Ingredient	Oxazepam
Dosage Form	Capsule
Route	Oral
Strength	30mg; 15mg; 10mg
Market Status	Prescription
Company	Sandoz; Actavis Elizabeth

4.2 Therapeutic Uses

Anti-Anxiety Agents, Benzodiazepine; GABA Modulators; Sedatives, Nonbarbiturate

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

... Oxazepam /is/ indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. ... /Included in US product labeling/

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 518

... Oxazepam /is/ indicated for the adjunctive management of anxiety associated with mental depression. Effectiveness of ... /this/ medication for long-term use has not been assessed in systematic clinical studies. The medication's efficacy in an individual patient should be reassessed at periodic intervals. /Included in US product labeling/

... Oxazepam ... /is/ indicated for the relief of acute alcohol withdrawal symptoms such as acute agitation, tremor, impending or acute delirium tremens, and hallucinosis. /Included in US product labeling/

4.3 Drug Warning

Late third trimester use and exposure during labor seems to be associated with much greater risks to the fetus and neonate. Some infants exposed at this time exhibit either the floppy infant syndrome or marked neonatal withdrawal symptoms. Symptoms vary from mild sedation, hypotonia, and reluctance to suck, to apneic spells, cyanosis, and impaired metabolic responses to cold stress. These symptoms have been reported to persist for periods from hours to months after birth. This correlates well with the pharmacokinetic and placental transfer of the benzodiazepines and their disposition in the neonate. /Benzodiazepines/

Dart, R.C. (ed). Medical Toxicology. Third Edition, Lippincott Williams & Wilkins. Philadelphia, PA. 2004., p. 817

Potentially serious, adverse behavioral effects occasionally have been associated with benzodiazepine use. Such effects include confusion, bizarre or abnormal behavior, agitation, hyperexcitability, auditory and visual hallucinations, paranoid ideation, panic, delirium, agitation, sleepwalking, aggression and antisocial acts; in some cases, amnesia about the behavior may occur. ... /Benzodiazepines/

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 2376

Benzodiazepine abuse is common and occurs with all benzodiazepines. ... /Benzodiazepines/

Dart, R.C. (ed). Medical Toxicology. Third Edition, Lippincott Williams & Wilkins. Philadelphia, PA. 2004., p. 819

Patients should be warned that benzodiazepines may impair ability to perform hazardous activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle). Patients also should be warned about possible effects on memory (anterograde amnesia) and to report promptly to their physician any behavioral or mental change, including disturbing thought and unusual manners of conduct, that develops during benzodiazepine therapy. Benzodiazepines should be used with caution and large quantities of the drugs should not be prescribed for patient with suicidal tendencies or whose history indicates that they may increase dosage on their own initiative. /Benzodiazepines/

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 2376

For more Drug Warnings (Complete) data for OXAZEPAM (16 total), please visit the HSDB record page.

4.4 Drug Indication

Oxazepam is indicated for the management of anxiety disorders and for the short-term relief of symptoms of anxiety. It may also be used in the management of alcohol withdrawal symptoms.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Benzodiazepines, including oxazepam, exert their sedative and anxiolytic effects by potentiating the effects of endogenous GABA, the primary inhibitory neurotransmitter in the CNS. Compared to other benzodiazepines, it has relatively low potency and a moderate duration of action. Oxazepam should be administered with caution to patients for whom a drop in blood pressure may lead to cardiac complications as, in rare cases, it may cause hypotension.

5.2 MeSH Pharmacological Classification

GABA Modulators

Substances that do not act as agonists or antagonists but do affect the GAMMA-AMINOBUTYRIC ACID receptor-ionophore complex. GABA-A receptors (RECEPTORS, GABA-A) appear to have at least three allosteric sites at which modulators act: a site at which BENZODIAZEPINES act by increasing the opening frequency of GAMMA-AMINOBUTYRIC ACID-activated chloride channels; a site at which BARBITURATES act to prolong the duration of channel opening; and a site at which some steroids may act. GENERAL ANESTHETICS probably act at least partly by potentiating GABAergic responses, but they are not included here. (See all compounds classified as GABA Modulators.)

Hypnotics and Sedatives

Drugs used to induce drowsiness or sleep or to reduce psychological excitement or anxiety. (See all compounds classified as Hypnotics and Sedatives.)

Anti-Anxiety Agents

Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here. (See all compounds classified as Anti-Anxiety Agents.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

OXAZEPAM

5.3.2 FDA UNII

6GOW6DWN2A

5.3.3 Pharmacological Classes

Benzodiazepines [CS]; Benzodiazepine [EPC]

5.4 ATC Code

N05BA04

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

N - Nervous system

N05 - Psycholeptics

N05B - Anxiolytics

N05BA - Benzodiazepine derivatives

N05BA04 - Oxazepam

5.5 Absorption, Distribution and Excretion

Absorption

Following oral administration, peak plasma levels (C_max) averaged 450 mg/mL and occurred approximately 3 hours (T_max) after dosing.

Route of Elimination

Oxazepam is primarily eliminated in the urine as its glucuronide metabolite, with the feces containing approximately 21% of the unchanged drug. The majority of an orally ingested dose of oxazepam is excreted within 48 hours.

The miniature swine (like humans) eliminated oxazepam primarily as the glucuronides, while aromatic hydroxylation predominated in the rat. In rats, 70.7 +/- 6.0% of a single oral dose of 20 mg/kg bw was eliminated in feces following biliary secretion, while 18.9 +/- 2.4% of the dose was found in the urine. In CD-1 mice given an oral dose of 22 mg/kg bw oxazepam, 57.8% was recovered from the feces and 27.3% was recovered from urine over five days. ... Treatment with 2500 mg/kg diet (ppm) oxazepam in the diet for 14 days before administration of oxazepam by gastric instillation led to a shift from fecal to urinary excretion in mice, but not rats, so that the urinary excretion almost doubled.

IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V66 126 (1996)

Oxazepam accumulates in adipose tissue. /It was/ found that adipose tissue/blood ratios of the drug in mice given 5 mg/kg bw intravenously varied from 1.7 (at 5 min) to 4.9 (at 30 min). Accumulation also occurred in the brain. Maximal concentrations of oxazepam in the brain were 14.3 +/- 0.17 ug/g in mice, 4.5 +/- 0.03 ug/g in rats and 3.5 +/- 0.47 ug/g in guinea-pigs, all at 5 min. Brain/blood drug level ratios in these species varied from 1.1 (at 1 min) to 11.3 (at 10 hr) in mice, from 1.9 (at 1 min) to 6.2 (at 1 hr) in rats and from 1.9 (at 5 min) to 8.9 (at 5 hr) in guinea-pigs.

/It was/ found that the time of maximum absorption of 30 mg oxazepam was 2.2 hr (range, 0.75-4.25 hr) in 18 men and 3.1 hr (range, 0.5-8.0 hr) in 20 women. The maximal plasma concentrations in this study were 622 +/- 37 ng/mL in men and 837 +/- 51 ng/mL in women.

Oxazepam is absorbed fairly rapidly, reaching peak plasma concentrations within 1-4 hr, with a mean of about 2 hr in most studies.

The plasma concentrations of oxazepam in male B6C3F1 mice fed diet containing 125 and 2500 mg/kg (ppm) oxazepam appeared to reach steady-state levels by one week of feeding. These levels were 1 ug/mL for the low-dose group and 5-10 ug/mL for the high-dose group

5.6 Metabolism/Metabolites

Oxazepam has a single major inactive metabolite, a glucuronide conjugate. The glucuronidation of the S-isomer is catalyzed by UGT2B15. The glucuronidation of the R-isomer is catalyzed by UGT2B7 and UGT1A9.

The metabolism and the anticonvulsant effect of clorazepate were followed for 2 h after its i.v. administration to mice. The ED50 of the drug was 12 mg/kg at 1 min against pentetrazole-induced convulsions (45 mg/kg i.v.), it reached a minimum at 1 hr (2.0 mg/kg) and rose to 2.7 mg/kg at 2 h. The concentrations of unchanged clorazepate and its metabolites, desmethyldiazepam and oxazepam, were determined in plasma and brain after administration of the respective ED50s. Unchanged clorazepate could be detected in plasma for the first hour but never in brain, so it can be considered as inactive pro-drug. The brain concentrations of desmethyldiazepam and oxazepam after the respective ED50s of clorazepate were considerably higher at 1 and 15 min than after longer time intervals. This may be explained by a time lag needed to reach and bind to the benzodiazepine receptor.

PMID:2908106 Frey HH, Scherki R; Eur J Pharmacol 158 (3): 213-6 (1988)

... Oxazepam ... /is/ metabolized by direct conjugation with glucuronic acid.

Oxazepam is a commonly used 1,4-benzodiazepine anxiolytic drug that is polymorphically metabolized in humans. However, the molecular basis for this phenomenon is currently unknown. We have previously shown that S-oxazepam glucuronide, the major oxazepam metabolite, is selectively formed by UDP-glucuronosyltransferase (UGT) 2B15, whereas the minor Roxazepam glucuronide is produced by multiple UGTs other than UGT2B15. Phenotype-genotype studies were conducted using microsomes and DNA prepared from the same set of 54 human livers. Sequencing of the UGT2B15 gene revealed three nonsynonymous polymorphisms, D85Y, T352I, and K523T, with variant allele frequencies of 0.56, 0.02, and 0.40, respectively. D85Y genotype showed a significant effect (p = 0.012) on S-oxazepam glucuronidation with lower median activities in 85Y/Y livers (49 pmol/min/mg protein) compared with 85D/D livers (131 pmol/min/mg), whereas 85D/Y livers were intermediate in activity (65 pmol/min/mg). There was also a significant trend (p = 0.049) for higher S-oxazepam activities in the two 352T/I livers (135 and 210 pmol/min/mg) compared with the remaining 352T/T livers (median, 64 pmol/min/mg). Conversely, K523T genotype had no apparent effect on oxazepam glucuronidation (p > 0.05). Donor gender also significantly influenced S-oxazepam glucuronidation with higher median activities in male (65 pmol/min/mg) compared with female (39 pmol/min/ mg) livers (p = 0.042). R-Oxazepam glucuronidation was not affected by either genotype or gender (p > 0.05). In conclusion, gender and D85Y genotype are identified as major determinants of S-oxazepam glucuronidation by human liver and may explain in part polymorphic oxazepam glucuronidation by human subjects.

PMID:15044558 Court MH et al; J Pharmacol Exp Ther 310 (2): 656-65 (2004)

There are three major pathways of oxazepam metabolism in mice and rats (as in humans): direct conjugation, phenyl ring oxidation and diazepine ring contraction. In mice, conjugation is mainly with glucuronide, predominantly excreted in the urine; in rats, conjugation is mainly with sulfate, which is almost entirely eliminated in the feces. The sulfate conjugate of oxazepam, which is unstable in acidic media, may be the source of the fecal oxazepam It has not been detected in mice. Studies with recirculating, perfused male Swiss (CD-1) mouse liver preparations showed that oxazepam glucuronides are the dominant liver metabolites in this species. Oxazepam can also be conjugated with glucuronide by the placenta of rabbits, apparently in contrast to the human organ. Phenyl ring oxidation is more important in rats than in mice (or humans) and a dihydrodiol (probably the 3',4'- dihydrodiol, since 2'-hydroxy derivatives are not known) accounts for about 30% of the 72-hr urinary metabolites in Fischer 344 rats. This metabolite, which probably forms via an arene oxide intermediate and has not been found in mice, holds implications for the toxicological properties of oxazepam. In rats, ring contraction to 6-chloro-4-phenyl- 2(1H)-quinazoline carboxylic acid occurs to roughly one half of the extent seen in mice.

A method for the extraction of diazepam and its metabolites (nordiazepam, temazepam, and oxazepam) from equine urine and serum and their quantitation and confirmation by liquid chromatography-tandem mass spectrometry is presented. Valium, a formulation of diazepam, was administered at a dose of 10 mg intramuscularly to four standard-bred mares. Diazepam is extensively metabolized in the horse to nordiazepam, temazepam, and oxazepam. Diazepam urinary concentrations were found to be less than 6 ng/mL. Nordiazepam was found to be mainly in its glucuronide-conjugated form and was measured out to a collection time of 53-55 hr. Oxazepam and temazepam were entirely conjugated, and their urinary concentrations were measured out to collection times of 121 hr and 77-79 hr, respectively. Diazepam and nordiazepam were measured in equine postadministration serum out to collection times of 6 and 54 hr, respectively. Oxazepam and temazepam were not detected in postadministration serum.

PMID:10022206 Marland A et al; J Anal Toxicol 23 (1): 29-34 (1999)

Oxazepam has known human metabolites that include Oxazepam glucuronide.

Oxazepam is a known human metabolite of nordiazepam and schembl29464.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

5.7 Biological Half-Life

The mean elimination half-life of oxazepam is 8.2 hours.

Considerable variation in the elimination half life has been reported, with mean values ranging from about 5 to about 15 hr. Values of 6.7 hr (range, 5.5-9.2 hr) and 5.8 hr (range, 5.4- 8.4 hr) /were found/ following intravenous and oral administration, respectively. A sex difference has been reported, with a value of 7.8 +/- 0.4 hr (range, 4.9-10.8 hr) in men and 9.7 +/- 0.8 hr (range, 6.3-19.4 hr) in women.

Elimination half-life of oxazepam is 3-21 hr. /From table/

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 2380

5.8 Mechanism of Action

Like other benzodiazepines, oxazepam exerts its anxiolytic effects by potentiating the effect of gamma-aminobutyric acid (GABA) on GABA(A) receptors, the main inhibitory neurotransmitter receptors in the mammalian brain. GABA(A) receptors are a component of GABA-gated ionotropic chloride channels that produce inhibitory postsynaptic potentials - following activation by GABA, the channel undergoes a conformational change that allows the passage of chloride ions through the channel. The inhibitory potentials produced by GABA neurotransmission play an integral role in the suppression and control of epileptiform nerve firing such as that seen in epilepsy, which makes the GABA system a desirable target in the treatment of epilepsy. Benzodiazepines are positive allosteric modulators of GABA(A) function. They bind to the interface between alpha () and gamma () subunits on the receptor, commonly referred to as the benzodiazepine binding site, and modulate the receptor such that its inhibitory response to GABA binding is dramatically increased.

The inhibitory neurotransmitter, gamma-aminobutyric acid (GABA), acts on GABAA receptors to regulate vigilance, anxiety, muscle tension, epileptogenic activity and memory functions. Benzodiazepines modulate GABA-evoked chloride currents through a binding site on the GABAA receptor-operated chloride channel. GABA agonists and benzodiazepine agonists simultaneously enhance the binding of the other to its receptor. Benzodiazepine binding appears to shift the GABA receptor from a low affinity state to a high affinity state and also stabilizes the receptor in a conformation that permits the ion channel to remain open. Similarly, GABA binding also enhances benzodiazepine agonist binding to its receptor via the same mechanism. Thus, GABA receptor agonist and benzodiazepine receptor agonists are positive allosteric effectors for each other.

Dart, R.C. (ed). Medical Toxicology. Third Edition, Lippincott Williams & Wilkins. Philadelphia, PA. 2004., p. 816-7

The exact sites and mode of action of the benzodiazepines are unknown. The drugs appear to act at the limbic, thalamic, and hypothalamic levels of the CNS, producing anxiolytic, sedative, hypnotic, skeletal muscle relaxant, and anticonvulsant effects. The effects of benzodiazepines may be mediated through the inhibitory neurotransmitter gamma-aminobutyric acid. Benzodiazepines are capable of producing all levels of CNS depression from mild sedation to hypnosis to coma. /Benzodiazepines/

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 2379

Anxiolytic and possibly paradoxical CNS stimulatory effects of benzodiazepines are postulated to result from release of previously suppressed responses (disinhibition). After usual doses of benzodiazepines for several days, the drugs cause a moderate decrease in rapid eye movement sleep. Rapid eye movement rebound does not occur when the drugs are withdrawn. Stage 3 and 4 sleep are markedly reduced by usual doses of the drugs; the clinical importance of these sleep stage alterations has not been established. /Benzodiazepines/

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 2379

Benzodiazepines appear to produce skeletal muscle relaxation predominantly by inhibiting spinal polysynaptic afferent pathways, but the drugs may also inhibit monosynaptic afferent pathways. The drugs may inhibit monosynaptic and polysynaptic reflexes by acting as inhibitory neuronal transmitters or by blocking exitatory synaptic transmission. The drugs may also directly depress motor nerve and muscle function. /Benzodiazepines/

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 2379

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Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

01 Embera NeuroTherapeutics

U.S.A

BIO Partnering at JPM

Not Confirmed

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FDF Dossiers

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FDA Orange Book

01

ALPHARMA US PHARMS

Ireland

BIO Partnering at JPM

Not Confirmed

Not Confirmed

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Europe

01

Pfizer

U.S.A

BIO Partnering at JPM

Not Confirmed

Not Confirmed

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Canada

01

APOTEX INC

Canada

Canada

BIO Partnering at JPM

Not Confirmed

05

Pharmascience Inc.

Canada

BIO Partnering at JPM

Not Confirmed

06

PRO DOC LIMITEE

Canada

Country

BIO Partnering at JPM

Not Confirmed

10

LABORATOIRE RIVA INC.

Country

BIO Partnering at JPM

Not Confirmed

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Australia

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South Africa

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Listed Dossiers

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Excipients by Applications

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Fillers, Diluents & Binders

Coating Systems & Additives

Direct Compression

Controlled & Modified Release

Disintegrants & Superdisintegrants

Lubricants & Glidants

Granulation

Thickeners and Stabilizers

Film Formers & Plasticizers

Co-Processed Excipients

Empty Capsules

Taste Masking

Topical

Coloring Agents

Emulsifying Agents

Chewable & Orodispersible Aids

Vegetarian Capsules

API Stability Enhancers

Solubilizers

Parenteral

Rheology Modifiers

Surfactant & Foaming Agents

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DATA COMPILATION #PharmaFlow

DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024. Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each. The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders). View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453 US$ 3,21,920 Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427 US$ 2,31,952 FDF—Foreign US$ 2,35,427 US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629 US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852 US$ 7,56,666 Small business generic drug applicant US$ 1,72,963 US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.

Impressions: 6671

NEWS #PharmaBuzz

Benzodiazepine prescriptions, overdose deaths on the rise in U.S.

26 Feb 2016

// Madeline Kennedy REUTERS

Global Sales Information

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US Medicaid Prescriptions

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Finished Drug Prices

01

Brand Name : Limbial

U.S.A

BIO Partnering at JPM

Not Confirmed

02

Brand Name : Serpax

U.S.A

U.S.A

BIO Partnering at JPM

Not Confirmed

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Market Place

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APIs

Oxazepam (2 kg) API needed in India [ENA21619]

A company that focuses on research, development and manufacturing of tablets and capsules is looking for suppliers of Oxazepam (2 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.

02 Jan 2025

Oxazepam API needed in India [ENA08181]

A sourcing expertise based in India that focuses on servicing the pharmaceutical industries such as raw materials, regulatory requirements & supply chain compliance is looking for suppliers of Oxazepam API. The suppliers must support this enquiry with Chinese DMF/CEP/USDMF. Interested suppliers can contact them via their email id: sethuraman@competepharmainc.in.

07 Aug 2020

Oxazepam (100 kg) API needed in South Africa [ENA07938]

Health and Home Pharmacy, a company based in South Africa that deals in marketing of finished dosage formulations is looking for suppliers of Oxazepam (100 kg) API for tender purposes. The suppliers must support this enquiry with CEP. Interested suppliers can contact them via their email: viral.desai@pharmacygroup.co.za.

17 Jul 2020

CEP grade Oxazepam API (300 kg) needed in India [ENA05384]

A UK based pharmaceutical company is looking for suppliers of CEP grade Oxazepam API (300 kg). The quarterly supply will be 75 kg.

09 Oct 2019

CEP grade Oxazepam API (240 to 280 kg yearly) needed in India [ENA03028]

A UK based pharmaceutical company is looking for suppliers of CEP grade Oxazepam API (240 to 280 kg) for manufacturing finished formulations. The first shipment would be around 30 kg.

24 Dec 2018

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REF. STANDARDS & IMPURITIES

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EDQM

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USP

Others

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ABOUT THIS PAGE

Oxazepam Manufacturers

A Oxazepam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxazepam, including repackagers and relabelers. The FDA regulates Oxazepam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxazepam API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Oxazepam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Oxazepam Suppliers

A Oxazepam supplier is an individual or a company that provides Oxazepam active pharmaceutical ingredient (API) or Oxazepam finished formulations upon request. The Oxazepam suppliers may include Oxazepam API manufacturers, exporters, distributors and traders.

click here to find a list of Oxazepam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Oxazepam USDMF

A Oxazepam DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxazepam active pharmaceutical ingredient (API) in detail. Different forms of Oxazepam DMFs exist exist since differing nations have different regulations, such as Oxazepam USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Oxazepam DMF submitted to regulatory agencies in the US is known as a USDMF. Oxazepam USDMF includes data on Oxazepam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxazepam USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Oxazepam suppliers with USDMF on PharmaCompass.

Oxazepam CEP

A Oxazepam CEP of the European Pharmacopoeia monograph is often referred to as a Oxazepam Certificate of Suitability (COS). The purpose of a Oxazepam CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oxazepam EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oxazepam to their clients by showing that a Oxazepam CEP has been issued for it. The manufacturer submits a Oxazepam CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oxazepam CEP holder for the record. Additionally, the data presented in the Oxazepam CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oxazepam DMF.

A Oxazepam CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oxazepam CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Oxazepam suppliers with CEP (COS) on PharmaCompass.

Oxazepam WC

A Oxazepam written confirmation (Oxazepam WC) is an official document issued by a regulatory agency to a Oxazepam manufacturer, verifying that the manufacturing facility of a Oxazepam active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Oxazepam APIs or Oxazepam finished pharmaceutical products to another nation, regulatory agencies frequently require a Oxazepam WC (written confirmation) as part of the regulatory process.

click here to find a list of Oxazepam suppliers with Written Confirmation (WC) on PharmaCompass.

Oxazepam NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Oxazepam as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Oxazepam API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Oxazepam as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Oxazepam and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oxazepam NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Oxazepam suppliers with NDC on PharmaCompass.

Oxazepam GMP

Oxazepam Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Oxazepam GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Oxazepam GMP manufacturer or Oxazepam GMP API supplier for your needs.

Oxazepam CoA

A Oxazepam CoA (Certificate of Analysis) is a formal document that attests to Oxazepam's compliance with Oxazepam specifications and serves as a tool for batch-level quality control.

Oxazepam CoA mostly includes findings from lab analyses of a specific batch. For each Oxazepam CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Oxazepam may be tested according to a variety of international standards, such as European Pharmacopoeia (Oxazepam EP), Oxazepam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oxazepam USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

10 API Suppliers

9 USDMF

2 CEP/COS

1 EU WC

4 NDC API

5 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

119 FDF Dossiers

31 FDA Orange Book

33 Europe

12 Canada

28 Australia

13 South Africa

2 Listed Dossiers

RELATED EXCIPIENT COMPANIES

3 SPI Pharma

8 DKSH

5 Faran Shimi Pharmaceutical

9 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

4 ACG Worldwide

1 Actylis

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

6 BASF

10 Corel Pharma Chem

3 DFE Pharma

2 Finar

4 Gangwal Chemicals

4 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

26 Kerry

3 Kima Chemical

6 Lonza Capsugel

8 Microlex e.U

1 Novo Excipients

5 Pluviaendo

2 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

9 Roquette

8 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

4 Sigachi Industries

2 The Dow Chemical Company

1 Valens Pharmachem

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

48 Fillers, Diluents & Binders

45 Coating Systems & Additives

19 Direct Compression

18 Controlled & Modified Release

14 Disintegrants & Superdisintegrants

12 Lubricants & Glidants

12 Granulation

10 Thickeners and Stabilizers

9 Film Formers & Plasticizers

9 Co-Processed Excipients

9 Empty Capsules

7 Taste Masking

6 Topical

5 Coloring Agents

5 Emulsifying Agents

4 Chewable & Orodispersible Aids

4 Vegetarian Capsules

4 API Stability Enhancers

4 Solubilizers

3 Parenteral

2 Rheology Modifiers

1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow