Parenteral administration, ophthalmic drugs

For drug preparations that will be used for internal or mucous membrane administration (i.e., parenteral preparations, ophthalmics, creams and salves, etc.), additional testing must be performed to assure that any leachants will not cause biological reactions that may be detrimental to the patient. To do this, a test protocol has been established that screens materials used in containers to test for biological interactions. This protocol should be applied to any plastic container closure systems regardless of the type of container that will directly contact pharmacopeial preparations in storage before they are invasively used. This includes all closure systems for parenteral vials. ... 

Formulations in nanosuspensions are used in different routes of administrations, such as oral, parenteral, topical, ophthalmic, mucoadhesive, pulmonary, and targeted drug delivery. 

In-depth discussions of the anatomy of the eye and adnexa have been adequately covered elsewhere in the pharmaceutical literature [13-17] and in recent texts on ocular anatomy. Here a brief overview is presented of the critical anatomical features that influence the nature and administration of ophthalmic preparations. In this discussion, consideration will be given primarily to drugs applied topically, that is, onto the cornea or conjunctiva or into the palpebral fornices. Increasingly, drugs are being developed for administration by parenteral-type dosage forms subconjunctivally, into the anterior and posterior chambers, the vitreous chamber, Tenon s capsule, or by retrobulbar injection. 

Table 3 indicates the preclinical safety studies for CAPTISOL (25) conducted as of 2005. The strategic safety plan for CAPTISOL was designed based on the guidelines discussed in the 1990s by the International Pharmaceutical Excipients Council which resulted in the May 2005 issuance of the FDA Guidance (26) Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients. These studies and others in the CAPTISOL Drug Master File have delineated the safety of CAPTISOL (SBE7-P-CD) for parenteral, ophthalmic, oral, nasal, and inhalation administration. 

All routes of drug administration can affect ocular structures and functions. OADRs have been associated with topical ophthalmic administrations as well as local injections. Systemically, oral drug administration has been implicated most frequently in the development of OADRs. However, parenteral as well as inhaled or nasally applied drugs have also produced OADRs. Topical application to the skin, particularly if it is abraded or burned, may result in sufficient systemic absorption to lead to ocular side effects. Dermatologic use of antibiotics has resulted in ocular hypersensitivity reactions. 

As excipients, CDs have been widely used to cover the bitter taste of drugs, to increase their dissolution rates, to reduce irritation reactions and in low concentrations to suppress the haemolysis induced by some drugs [180]. Great effort has been made to develop CD-based drug formulations with different administrative routes, including parenteral, oral, pulmonary, nasal [181], transdermal, rectal [182] and ophthalmic [183] drug delivery [184]. 

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