Acetate Oral Suspension

MEGACE oral suspension is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per milliliter. MEGACE oral suspension contains the following inactive ingredients alcohol (maximum of 0.06% 

Charge glycerol, sorbitol, and polysorbate in a suitable container. Mix well. 

Charge xanthan gum in a separate vessel with item 10 and allow overnight hydration. 

Add sodium citrates, sucrose, sodium benzoate, and flavor to step 1 and then add step 2 to step 1. 

Add megestrol acetate and pass then suspension through a colloid mill or homogenizer to provide a uniform oral suspension. 

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Table 7.1 Hydrocortisone Acetate Oral Suspension 0.5 caine Hydrochloride and Dexpanthenol [12]...

Cortisone (25 to 300 mg/day) is insoluble in water. Cortisone acetate (Biofine) is available in a 25-mg tablet. Hydrocortisone (cortisol, 20 to 240 mg/day) exists in suspension and is insoluble in water. Hydrocortisone cypionate (Cortef, 20 to 240 mg/day) is available in an oral suspension. Hydrocortisone sodium phosphate, a water-soluble salt with a rapid onset but short duration of action, is available for IV, IM, or SC injection. Hydrocortisone sodium succinate (Solu-Cortef) in an initial dose of 100 to 500 mg may be administered IV or IM. The antiinflammatory effect of corfisol is relatively weak (Table 11). 

For the analysis of penicillin V benzathine oral suspensions (II), the sample and standard solutions (1 pi, equivalent to 1-10 pg penicillin V) spotted on an HPTLC-F254 silica gel plate (Merck). The solvent was acetonc/chloroform/acetic acid (10 9 1). The plate was developed for cm, air-dried, and measured at 230 nm (see Fig. 2). The Revalues were... 

Oxytetracycline preparations for oral administration should contain not less than 90% or not more than 120% [i] or not less than 90% and not more than 110% [2], of the labeled amount. For ointment, the requirements are not less than 90.0% and not more than 115% (for oxytetracycline HC1 and Hydrocortisone ointment, or 120% for other ointment. For ophthalmic suspension mixture with hydrocortisone acetate, its content should contain not less than 90% and not more than 110% [1]. 

Glucocorticoids are available in a wide range of preparations, so that they can be administered parenterally, orally, topically, or by inhalation. Obviously the oral route is preferred for prolonged therapy. However, parenteral administration is required in certain circumstances. Intramuscular injection of a water-soluble ester (phosphate or succinate) formed by esterification of the C21 steroid alcohol produces peak plasma steroid levels within 1 hour. Such preparations are useful in emergencies. By contrast, acetate and tertiary butylacetate esters must be injected locally as suspensions and are slowly absorbed from the injection site, which prolongs their effectiveness to approximately 8 hours. 

The drug is commercially available as the acetate ester, being esterified at the hydroxy methyl group (at C21). It is formulated as oral tablets (dosage strengths of 5 mg, 10 mg, and 25 mg), or as a parenteral sterile suspension (50 mg/mL) for intra-muscular administration. 

Oral 20, 40 mg tablets 40, 125 mg/mL suspension Norethindrone acetate (generic, Aygestin)... 

Paper partition chromatographic methods have been widely applied to the analysis of tetracyclines (128, 129). Pharmaceutical aqueous suspensions for oral use are acidified with HC1 and diluted with methanol. Crystalline formulations are dissolved only in methanol. A paper chromatographic method for TC determination in pharmaceutical preparations is based on the complexation of the antibiotic with a mixture of urea and disodium edetate on paper at pH 7.4. Urea helped in the separation of degradation products and led to the formation of well defined spots (130). Samples from fermentations must be acidified with oxalic acid to liberate TC from the mycelium. TC in filtrates may be precipitated in saturated solution of sodium tetraphenyl borate, precipitate dissolved in ethyl or butyl acetate and applied for paper chromatography. Various solvent systems and hRp values for paper chromatography are given in Table 4. 

Hydrocortisone (cortisol) is the principal naturally occurring steroid it is taken orally a soluble salt can be given i.v. for rapid effect in emergency (whether due to deficiency, allergy or inflammatory disease). A suspension (Hydrocortisone Acetate Inj.) can be given intra-articularly. 

The prodrug approach described above also can be used to alter the solubility characteristics, which, in turn, can increase the flexibility in formulating dosage forms. The solubility of methylprcdnisolonc can be altered from essentially water-insoluble methylpredni.solone acetate to slightly water-insoluble methylprednisolone to water-soluble meth-ylprednisolone. sodium succinate. The water-soluble sodium hemisuccinate salt is used in oral, intravenous, and intramuscular dosage forms. Methylprednisolone itself is normally found in tablels. The acetate ester is found in topical ointments and sterile aqueous suspensions for intramuscular injection. Both the succinate and acetate esters are hydrolyzed to the active methylprednisolone by the patient s own systemic hydrolytic enzymes (esterases). 

Hydrocortisone and hydrocortisone cypionate (Cortef) may be administered orally. Hydrocortisone sodium phosphate may be administered by IM, SC, or IV injection, or by IV infusion, q. 12-hour interval. Hydrocortisone sodium succinate (A-hydroCort, Lifocort, Solu-Cortef) may be administered by IM or rV injection or IV infusion q. 2 to 10 hours, depending on the clinical situation. Hydrocortisone acetate is a suspension that may be administered by intra-articular, intrasynovial, intrabursal, intralesional, or soft tissue injection. It has a slow onset but a long duration of action. The injectable forms are usually used only when the oral dosage forms cannot be used (see also Table 11). 

Mouthwashes usually are solutions of active substances in water or aqueous solvents so the water soluble form of the active substance is chosen. For corticosteroids this would mean an aqueous solution of a phosphate ester. When rinsing with such a solution the contact time would be too short to obtain a sufficient therapeutic effect of the corticosteroid [1]. As a viscous suspension sticks to the oral mucosa, the active substance can work for a longer period of time. Therefore a (viscous) suspension is to be preferred. In addition such a suspension has the advantage that the bitter taste of the corticosteroid is less pronounced. An example is a suspensimi with hydrocortisone acetate, lidocaine and dexpanthenol (Table 7.1). 

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