Ophthalmic preparations ointments

Ophthalmic Dosage Forms. Ophthalmic preparations can be solutions, eg, eye drops, eyewashes, ointments, or aqueous suspensions (30). They must be sterile and any suspended dmg particles must be of a very fine particle size. Solutions must be particle free and isotonic with tears. Thus, the osmotic pressure must equal that of normal saline (0.9% sodium chloride) solution. Hypotonic solutions are adjusted to be isotonic by addition of calculated amounts of tonicity adjusters, eg, sodium chloride, boric acid, or sodium nitrate. 

Educating the Patient and Famiiy The patient or a family member will require instruction in die technique of instilling an ophthalmic preparation (see Home Care Checklist Instilling an Ophthalmic Preparation). In addition, die nurse may give the following information to die patient and family member when an eye ointment or solution is prescribed ... 

If more than one type of ophthalmic preparation is being instilled, waits the recommended time interval before instilling the second drug (usually 5 minutes for drops and 10-15 minutes for ointment). 

What is the percentage of ophthalmic hydrocortisone ointment prepared by mixing 10 grams of 2.5% hydrocortisone ointment, 8 g of 2% hydrocortisone ointment, and 14 g of ointment base (diluent) ... 

Selection of an appropriate base for an ointment or cream formulation depends on the type of activity desired (e.g., topical or percutaneous absorption), compatibility with other components, physicochemical and microbial stability of the product, ease of manufacture, pourability and spreadability of the formulation, duration of contact, chances of hypersensitivity reactions, and ease of washing from the site of application. In addition, bases that are used in ophthalmic preparations should be nonirritating and should soften at body temperatures. White petrolatum and liquid petrolatum are generally used in ophthalmic preparations. Table 1 summarizes... 

Topically administered ophthalmic preparations can affect visual acuity. Examples are lubricating gels and ointments for dry eye, antimicrobial ointments for ocular infections, and gel-forming solutions for glaucoma. Although acuity is only slightly reduced and is only temporary, this effect can be annoying to patients and may lead to noncompliance. 

Included in the FDA Inactive Ingredients Guide (ophthalmic preparations, oral capsules and tablets, otic and rectal preparations, topical aerosols, creams, emulsions, ointments and solutions, and vaginal preparations). Included in nonpar-enteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients. 

Sesame oil may be used as a solvent in the preparation of subcutaneous injections, oral capsules, rectal suppositories, and ophthalmic preparations it may also be used in the formulation of suspensions and emulsions. Multiple-emulsion formulations, in which sesame oil was one of the oil phases incorporated, have been investigated as a prolonged-release system for rifampicin microemulsions containing sesame oil have been prepared for the transdermal delivery of ketoprofen. Sesame oil has also been used in the preparation of liniments, pastes, ointments, and soaps. A sesame paste... 

Ophthalmic preparations (solutions and suspensions) are sterile aqueous preparations with other qualities essential to the safety and comfort of the patient. Ophthalmic ointments must be sterile and free from grittiness. 

Herpes zoster ophthalmicus is a latent reactivation of a varicella zoster infection in the first division of the trigeminal cranial nerve. Systemic acyclovir, valacyclovir, and famciclovir te. effective in reducing the severity and complications of herpes zoster ophthalmicus. Currently, there are no ophthalmic preparations of acyclovir approved by the FDA, although an ophthalmic ointment is available for investigational use. 

Vidarabine is used mainly in human HSV-1 and HSV-2 encephalitis, decreasing the mortality rate from 70 to 30%. Whitley et al. (57) reported that early vidarabine therapy is helpful in controlling complications of localized or disseminated herpes zoster in immunocompromised patients. Vidarabine also is useful in neonatal herpes labialis or genitalis, vaccinia virus, adenovirus, RNA viruses, papovavirus, CMV, and smallpox virus infections. Given the efficacy of vidarabine in certain viral infections, the U.S. FDA approved a 3% ointment for the treatment of herpes simplex keratoconjunctivitis and recurrent epithelial keratitis, and a 2% IV injection for the treatment of herpes simplex encephalitis and herpes zoster infections (Table 43.3). A topical ophthalmic preparation of vidarabine is useful in herpes simplex keratitis but shows little promise in herpes simplex labialis or genitalis. The monophosphate esters of vidarabine are more water-soluble and can be used in smaller volumes and even intramuscularly. These esters are under clinical investigation for the treatment of hepatitis B, systemic and cutaneous herpes simplex, and herpes zoster virus infections in immunocompromised patients. 

Ophthalmic preparation containing combretastatin A-4 for treating diabetic retinopathy was patented [111]. The ophthalmic preparation was composed of combretastatin A-4 and other auxiliary materials acceptable for treating eye diseases. The authors claimed the preparation could be used as eye drop, ointment, and gel for treating diabetic retinopathy by inhibiting angiogenesis in a dose-dependent manner without affecting the development of retina vascular system. 

Used as a cathartic, particularly in the treatment of food poisoning and in evacuation of the bowel before X-ray examination as a solvent or vehicle in some parenteral and ophthalmic preparations as an ingredient in lipsticks, hair-grooming products, ointments, creams, lotions, transparent soaps, suppository bases, and others. 

The NF and reagent grades are employed in the pharmaceutical industry which makes use of benzyl alcohol s local anesthetic, antiseptic, and solvent properties (17—20). It also finds use in cough symps and drops ophthalmic solutions bum, dental (21), and insect repeUant solutions and ointments and dermatological aerosol sprays. It is used in nail lacquers and as a color developer in hair dyes by the cosmetics industry (22), and in acne treatment preparations (23). 

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]. 

The provision of optimal drug action from topical administration sites (such as ointments, creams, transdermal patches, ophthalmic, ear, and nasal preparations)... 

Ophthalmic, nasal, and oral inhalation preparations Appearance, color, consistency, pH, clarity (solutions), particle size and resuspendibility (suspensions, ointments), strength, and sterility... 

The refractive index detector was one of the first on-line HPLC detectors used. Detection is based on changes in the refractive index of the effluent when an analyte is present versus the solvent alone. This detector is commonly used when an analyte does not have a suitable UV chromophore. An example would be the detection of carbohydrates in drug preparations or acetylcholine in an ophthalmic solution [102,103]. Figure 5.4 is a chromatogram of propylene glycol, propylene carbonate, and resorcinol in anhydrous ointment detected by a refractive index detector [104]. 

Not surprisingly, petrolatum has been cited as a major ingredient in patents that describe products for topical skin treatment.93-95 Some specific applications include ophthalmic ointments,96 lip care products,97 98 and aftershave preparations.99... 

Ointments are semisolid preparations intended for topical application. They are used to provide protective and emollient effects on the skin or carry medicaments for treating certain topical ailments. They are also used to deliver drugs into eye, nose, vagina, and rectum. Ointments intended for ophthalmic purposes are required to be sterile. When applied to the eyes, they reside in the conjunctival sac for prolonged periods compared to solutions and suspensions and improve the fraction of drug absorbed across ocular tissues. Ophthalmic ointments are preferred for nighttime applications as they spread over the entire corneal and conjunctival surface and cause blurred vision. 

Overall, ophthalmic ointments offer the following advantages reduced dilution of the medication via the tear film, resistance to nasolacrimal drainage, and an increased precorneal contact time [179,180], However, oily viscous preparations for ophthalmic use (such as ointments) can cause blurred vision and matting of the eyelids and may also be associated with discomfort by the patient as well as occasional ocular mucosal irritation. Ointments are therefore generally used in combination with eye drops, which can be administered during the day, while the ointment is applied at night, when clear vision is not required. 

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