Indomethacin capsules

Irradiation of gelatine capsules may not only result in photodegradation of the drug but may also affect the bioavailability of the drug. Irradiated gelatine films showed a decrease of their water vapor transmission. Even though this effect did not occur with indomethacin capsules, long-term irradiation resulted in increased dissolution rates (42). 

Hansen TM, Matzen P, Madsen P. Endoscopic evaluation of the effect of indomethacin capsules and suppositories on the gastric mucosa in rheumatic patients. J Rheumatol 1984 ll(4) 484-7. 

Matsuda, Y., Itooka, T., and Mitsuhashi, Y. (1980), Photostabihty of indomethacin in model gelatin capsules effects of film thickness and concentration of titanium dioxide on the coloration and photolytic degradation, Chem. Pharm. Bull., 28, 2665-2671. 

Mix the components for about 10 min and fill in hard gelatin capsules to obtain 160 mg indomethacin in each capsule. 

Analysis of capsules containing indomethacin is described in the USP/NF and the British Pharmacopeia (13,14). 

In aqueous methanol, indomethacin exhibits a half-wave potential (E.,-) at the droning mercury electrode which is dependent upon pH. In 0.1M methanolic lithium chloride, indomethacin has two waves between -1.4v and -1.6v (vs. S.C.E.). The first step height is diffusion controlled and corresponds to a two electron reduction of the amide carbonyl. The second wave is believed to be a kinetic wave. The method as described is specific for nonhydrolyzed indomethacin and is suitable for analysis of capsules, suppositories and suspensions with precision of +1.2%, +0.7% and +1.2% for the respective formulations(43). 

Assessment of indomethacin powder had been specified in the U.J5. XIX and the British Pharmacopeia, 1980 as a back titration with hydrochloric acid after alkaline hydrolysis(13,14). This method can attain a precision of + 0.8%(62). A direct titration for tablets and capsules is described using sodium hydroxide. If performed rapidly with phenolphthalein indicator, a precision of +0.3% is attainable. 8 The latter procedure serves to differentiate ester formation as well as hydrolysis products from intact material. The presence of parachlorobenzoic acid and 5-methoxy-2-methylindole-3-acetic acid are cause for positive error. 

Matsuda Y, Kouzuki K, Tanaka M, Tanigaki J. Photostability of gelatin capsules effect of ultraviolet irradiation on the vapor transmission properties and dissolution rates of indomethacin. Yakugaku Zassi 1979 99(9) 907-913. 

Tablets (e.g., quinapril hydrochloride) Capsules (e.g., pancrease) Oral suspensions (e.g., cefuroxime axetil) Injectables (e.g., coumadin) Sterile powders (e.g., cefoxitin) Topicals (e.g., zinc oxide powder) Anti-infectives (e.g., erythromycin ethyl succinate) Anti-coagulants (e.g., warfarin sodium) Anti-asthmatics (e.g., montelukast sodium) Anti-psychotics and anxiolytics Hypnotics and anticonvulsants (e.g., barbiturates) Anti-hypertensives Anti-inflammatories (e.g., indomethacin) Analgesics (e.g., aspirin) Antacids (e.g., aluminum hydroxide) Diuretics Enzymes (e.g., pancreatin) Hormones...

Specifications for extended-release products reflect the intended release profile of the product, which in some cases, may be relatively complex. The drug-release specification for Bupropion Hydrochloride Extended-Release Tablets USP requires 25-45% of the nominal content of drug to have dissolved after one hour, 60-85% after four hours and not less than 80% after eight hours. The specifications for Diltiazem Hydrochloride Extended-Release Capsules USP are even more complex, with 13 different tests being prescribed to cover the various products (Table 1). Other products with multiple profiles include Pentoxifylline Extended-release Capsules USP (10 tests). Lithium Carbonate Tablets USP (4 tests) and Indomethacin Extended-release capsules USP (3 tests). 

Cremophor RH 60/ Hydrogenated oil/Glyceryl monooleate Soybean oil/Hydrogenated vegetable oils/ Hydrogenated soybean oil Indomethacin famesil/ Infree Capsules Isotretinoin/Accutane ... 

Indomethacin farnesil/Infree Capsules/Eisai Co./ Anti-inflammatory and analgesic CH3 XXX/ A— 200 mg (1-2 capsules) b.i.d. Soft gelatin capsule 200 mg Cremophor RH 60 Hydrogenated oil Glyceryl monooleate ... 

Gelatin Capsules (160 mg) Indomethacin Suppositories (50 mg) Indomethacin Tablets (50 mg), DC Indomethacin Tablets (50 mg), WG Indomethacin Tablets (100 mg)... 

Figure 134. Stabilization of indomethacin coloration (light source mercury lamp) by the addition of titanium dioxide to gelatin capsule shells. Titanium dioxide concentration o,0 , 0.5% A, 1.0% , 1.5%. The values of k were calculated from die equation AE (color difference) = k( t /2 - 0.08). (Reproduced from Ref. 558 with permission.)...

Mahrous, M.S. et al (25). Derivative uv spectroscopy was used to determine the cited drugs in capsules and tablets. First derivative spectroscopy was used to determine indomethacin in O.IN-H2SO4 solution, and second derivative spectroscopy was used to determine naproxen and iboprofen in O.IN-NaOH solution. The method is rapid and accurate. 

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