Tyloxapol

Structure

Molecular Formula :

Chemical Names :
 Macrocyclon
 Superinone
 Alevaire
 Enuclene
 Tyloxypal

IUPAC Name : formaldehyde;oxirane;4-(2,4,4-trimethylpentan-2-yl)phenol

280.4 g/mol
Molecular Weight:

2D Structure
3D Conformer

Molecular Weight 280.4 g/mol

Hydrogen Bond Donor Count 1

 Hydrogen Bond Acceptor Count 3

Rotatable Bond Count 3

Exact Mass 280.203845 g/mol

Monoisotopic Mass 280.203845 g/mol

Topological Polar Surface Area 49.8 A^2

Heavy Atom Count 20

Formal Charge 0

Complexity 204

Isotope Atom Count 0

Defined Atom Stereocenter Count 0

Undefined Atom Stereocenter Count 0

Defined Bond Stereocenter Count 0

Undefined Bond Stereocenter Count 0

Covalently-Bonded Unit Count 3

Compound Is Canonicalized Yes

MeSH Pharmacological Classification

Surface-Active Agents
Agents that modify interfacial tension of water; usually substances that have one lipophilic
and one hydrophilic group in the molecule; includes soaps, detergents, emulsifiers,
dispersing and wetting agents, and several groups of antiseptics.

Detergents
Purifying or cleansing agents, usually salts of long-chain aliphatic bases or acids, that exert
cleansing (oil-dissolving) and antimicrobial effects through a surface action that depends on
possessing both hydrophilic and hydrophobic properties.

Indication
Tyloxapol is an inhaled surfactant that assists in removing and liquefying and
removing bronchopulmonary secretions with mucus and pus. Tyloxapol is
administered either through nebulized solution or a stream of oxygen. Also
investigated for use/treatment in cystic fibrosis and pediatric indications.
Pharmacodynamics
 It is used as a surfactant to aid liquefaction and removal of mucopurulent (containing
mucus and pus) bronchopulmonary secretions. Tyloxapol also blocks plasma lipolytic
activity, and thus the breakdown of triglyceride-rich lipoproteins.

Mechanism of action
Tyloxapol, when injected IP, blocks plasma lipolytic activity, and thus the breakdown
of triglyceride-rich lipoproteins. It has also been shown to be inhibitor of lipoprotein
lipase, thus preventing triglyceride uptake.

Hydrochloric Acid
1 Nonproprietary Names BP: Hydrochloric Acid JP: Hydrochloric Acid PhEur:
Hydrochloric Acid, Concentrated USP-NF: Hydrochloric Acid

2 Synonyms Acidum hydrochloridum concentratum; chlorohydric acid;

concentrated hydrochloric acid; E507.

3 Chemical Name and CAS Registry Number Hydrochloric acid [7647-01-0]

4 Empirical Formula and Molecular Weight HCl 36.46

5 Structural Formula See Section 4.

6 Functional Category Acidifying agent.

7 Applications in Pharmaceutical Formulation or Technology Hydrochloric acid

is widely used as an acidifying agent, in a variety of pharmaceutical and food
preparations (see Section 16). It may also be used to prepare dilute hydrochloric
acid, which in addition to its use as an excipient has some therapeutic use,
intravenously in the management of metabolic alkalosis, and orally for the
treatment of achlorhydria.

8 Description Hydrochloric acid occurs as a clear, colorless, fuming aqueous

solution of hydrogen chloride, with a pungent odor. The JP XV specifies that
hydrochloric acid contains 35.0–38.0% w/w of HCl; the PhEur 6.0 specifies that
hydrochloric acid contains 35.0–39.0% w/w of HCl; and the USP32–NF27
specifies that hydrochloric acid contains 36.5–38.0% w/w of HCl. See also

9 Typical Properties
 Acidity/alkalinity pH = 0.1 (10% v/v aqueous solution) Boiling point 1108C (constant boiling
mixture of 20.24% w/w HCl) Density 1.18 g/cm3 at 208C Freezing point 248C Refractive
index n D 20 = 1.342 (10% v/v aqueous solution) Solubility Miscible with water; soluble in
diethyl ether, ethanol (95%), and methanol.

11 Stability and Storage Conditions Hydrochloric acid should be stored in a well-closed, glass
or other inert container at a temperature below 308C. Storage in close proximity to
concentrated alkalis, metals, and cyanides should be avoided.

12 Incompatibilities Hydrochloric acid reacts violently with alkalis, with the evolution of a
large amount of heat. Hydrochloric acid also reacts with many metals, liberating hydrogen.

13 Method of Manufacture Hydrochloric acid is an aqueous solution of hydrogen chloride gas

produced by a number of methods including: the reaction of sodium chloride and sulfuric acid;
the constituent elements; as a by-product from the electrolysis of sodium hydroxide; and as a
by-product during the chlorination of hydrocarbons.

14 Safety When used diluted, at low concentration, hydrochloric acid is not usually associated
with any adverse effects. However, the concentrated solution is corrosive and can cause severe
damage on contact with the eyes and skin, or if ingested. LD50 (mouse, IP): 1.4 g/kg(1) LD50
(rabbit, oral): 0.9 g/kg

15 Handling Precautions Caution should be exercised when handling hydrochloric acid, and
suitable protection against inhalation and spillage should be taken. Eye protection, gloves, face
mask, apron, and respirator are recommended, depending on the circumstances and quantity of
hydrochloric acid handled. Spillages should be diluted with copious amounts of water and run
to waste. Splashes on the skin and eyes should be treated by immediate and prolonged washing
with large amounts of water and medical attention should be sought. Fumes can cause irritation
to the eyes, nose, and respiratory system; prolonged exposure to fumes may damage the lungs.
In the UK, the recommended short-term workplace exposure limit for hydrogen chloride gas
and aerosol mists is 8 mg/m3 (5 ppm). The long-term exposure limit (8-hour TWA) is 2 mg/m3
(1 ppm).(2)

IR Spectra
Hydroxyethyl Cellulose
1 Nonproprietary Names BP: Hydroxyethylcellulose PhEur: Hydroxyethylcellulose USP-NF:
Hydroxyethyl Cellulose

2 Synonyms Cellosize HEC; cellulose hydroxyethyl ether; cellulose 2-hydroxyethyl ether;

cellulose hydroxyethylate; ethylhydroxy cellulose; ethylose; HEC; HE cellulose; hetastarch; 2-
hydroxyethyl cellulose ether; hydroxyethylcellulosum; hydroxyethyl ether cellulose;
hydroxyethyl starch; hyetellose; Natrosol; oxycellulose; Tylose H; Tylose PHA.

3 Chemical Name and CAS Registry Number Cellulose, 2-hydroxyethyl ether [9004-62-0]

4 Empirical Formula and Molecular Weight The USP32-NF27 describes hydroxyethyl

cellulose as a partially substituted poly(hydroxyethyl) ether of cellulose. It is available in
several grades that vary in viscosity and degree of substitution; some grades are modified to
improve their dispersion in water. The grades are distinguished by appending a number
indicative of the apparent viscosity, in mPa s, of a 2% w/v solution measured at 208C.
Hydroxyethyl cellulose may also contain a suitable anticaking agent.

5 Structural Formula
6 Functional Category Coating agent; suspending agent; tablet binder; thickening agent;
viscosity-increasing agent.

7 Applications in Pharmaceutical Formulation or Technology Hydroxyethyl cellulose is a

nonionic, water-soluble polymer widely used in pharmaceutical formulations. It is primarily
used as a thickening agent in ophthalmic(1) and topical formulations,(2) although it is also used
as a binder(3) and film-coating agent for

8 Typical Properties Acidity/alkalinity pH = 5.5–8.5 for a 1% w/v aqueous solution. Ash 2.5%
w/w for Cellosize; 3.5% w/w for Natrosol. Autoignition temperature 4208C Density (bulk)
0.35–0.61 g/cm3 for Cellosize; 0.60 g/cm3 for Natrosol. Melting point Softens at 135–1408C;
decomposes at about 2808C. Moisture content Commercially available grades of
hydroxyethylcellulose contain less than 5% w/w of water. However, as hydroxyethyl cellulose
is hygroscopic, the amount of water absorbed depends upon the initial moisture content and
the relative humidity of the surrounding air. Typical equilibrium moisture values for Natrosol
250 at 258C are: 6% w/w at 50% relative humidity and 29% w/w at 84% relative humidity.
NIR spectra see Figure 1. Particle size distribution Cellosize: 100% through a US #80 mesh
(177 mm); Natrosol (regular grind): 10% retained on a US #40 mesh (420 mm); Natrosol (X-
grind): 0.5% retained on a US #60 mesh (250 mm).

9 Stability and Storage Conditions Hydroxyethyl cellulose powder is a stable though

hygroscopic material. Aqueous solutions of hydroxyethyl cellulose are relatively stable at pH
2–12 with the viscosity of solutions being largely unaffected. However, solutions are less stable
below pH 5 owing to hydrolysis. At high pH, oxidation may occur. Increasing the temperature
reduces the viscosity of aqueous hydroxyethyl cellulose solutions. However, on cooling, the
original viscosity is restored. Solutions may be subjected to freeze–thawing, high-temperature
storage, or boiling without precipitation or gelation occurring. Hydroxyethyl cellulose is
subject to enzymatic degradation, with consequent loss in viscosity of its solutions.(6) Enzymes
that catalyze this degradation are produced by many bacteria and fungi present in the
environment. For prolonged storage, an antimicrobial preservative should therefore be added
to aqueous solutions. Aqueous solutions of hydroxyethyl cellulose may also be sterilized by
autoclaving. Hydroxyethyl cellulose powder should be stored in a well-closed container, in a
cool, dry place.

12 Incompatibilities Hydroxyethyl cellulose is insoluble in most organic solvents. It is

incompatible with zein and partially compatible with the following water-soluble compounds:
casein; gelatin; methylcellulose; polyvinyl alcohol, and starch. Hydroxyethyl cellulose can be
used with a wide variety of watersoluble antimicrobial preservatives. However, sodium
pentachlorophenate produces an immediate increase in viscosity when added to hydroxyethyl
cellulose solutions. Hydroxyethyl cellulose has good tolerance for dissolved electrolytes,
although it may be salted out of solution when mixed with certain salt solutions. For example,
the following salt solutions will precipitate a 10% w/v solution of Cellosize WP-09 and a 2%
w/v solution of Cellosize WP-4400: sodium carbonate 50% and saturated solutions of
aluminum sulfate; ammonium sulfate; hromic sulfate; disodium phosphate; magnesium sulfate;
potassium ferrocyanide; sodium sulfate; sodium sulfite; sodium thiosulfate; and zinc sulfate.
Natrosol is soluble in most 10% salt solutions, excluding sodium carbonate and sodium sulfate,
and many 50% salt solutions with the exception of the following: aluminum sulfate;
ammonium sulfate; diammonium phosphate; disodium phosphate; ferric chloride; magnesium
sulfate; potassium ferrocyanide; sodium metaborate; sodium nitrate; sodium sulfite; trisodium
phosphate; and zinc sulfate. Natrosol 150 is generally more tolerant of dissolved salts than is
Natrosol 250. Hydroxyethyl cellulose is also incompatible with certain fluorescent dyes or
optical brighteners, and certain quaternary disinfectants which will increase the viscosity of
aqueous solutions.

Cellulose, 2-hydroxyethyl 2-hydroxypropyl ether

Chemical Names:
51331-09-0

Molecular Weight: 444.4 g/mol

2D Structure
AIR MURNI
Purified Water
Pemerian Cairan jernih, tidak berwarna; tidak berbau.

pH <1071> Antara 5,0 sampai 7,0; lakukan penetapan secara potensiometrik pada
larutan yang ditambahkan 0,30 ml larutan kalium klorida P jenuh pada 100 ml zat uji.

Klorida Pada 100 ml tambahkan 5 tetes asam nitrat P dan 1 ml perak nitrat LP: tidak
terjadi opalesensi.

Sulfat Pada 100 ml tambahkan 1 ml barium klorida LP: tidak terjadi kekeruhan.

Amonia Tidak lebih dari 0,3 bpj; pada 100 ml tambahkan 2 ml kalium raksa(II) iodida
alkalis P segera terbentuk warna kuning yang tidak lebih gelap dari Air dengan
kemurnian tinggi seperti tertera pada Pereaksi dalam Wadah <1271> yang
ditambahkan 30 μg NH3.

Kalsium Pada 100 ml tambahkan 2 ml amonium oksalat P: tidak terjadi kekeruhan.

Karbon dioksida Pada 25 ml tambahkan 25 ml kalsium hidroksida LP: campuran tetap

jernih.
Logam berat <371> Pada 40 ml Air Murni atur pH antara 3,0 sampai 4,0 dengan
penambahan asam asetat 1 N (gunakan kertas indikator dengan rentang pH pendek),
tambahkan 10 ml hidrogen sulfida LP yang dibuat segardandiamkan selama 10 menit;
jika diamati dengan arah tegak lurus dengan dasar putih, warna cairan tidak lebih tua
dari warna campuran 50 ml air murni dengan asam asetat 1 N dalam jumlah yang
sama.

Zat mudah teroksidasi Pada 100 ml tambahkan 10 ml asam sulfat 2 N, tambahkan

hingga mendidih. Tambahkan 0,1 ml kalium permanganat 0,1 N, didihkan selama 10
menit: warna merah muda tidak hilang sempurna.

Zat padat total Tidak lebih dari 0,001%; uapkan 100 ml di atas tangas uap hingga
kering, keringkan residu pada suhu 105o selama 1 jam.

Kemurnian bakteriologi Memenuhi syarat air minum. Wadah dan penyimpanan

Dalam wadah tertutup rapat.