Pharmaceutical Manufacturing Handbook: Production and

836 VAGINAL DRUG DELIVERY
5.12.4.12 Packaging and Vaginal Applicators
Vaginal packaging and applicators are an integral part of vaginal products. Packaging
is designed to accommodate and protect formulations, while applicators should
allow their convenient administration in the vagina. Several materials have been
used to manufacture these devices, such as plastics (e.g., polypropylene and polyethylene)
and nonlatex rubber. Besides compatibility, stability, and suitability issues,
these materials should be selected regarding the fi nal cost of packaging and
applicators.
Applicators are intended to be introduced in the vagina, adequately deliver the
product, and then be removed. Their design relates to safety (e.g., relationship with
product purity and stability, avoidance of local trauma associated with insertion or
use), effi cacy (e.g., consistent delivery of the required amount of product in the
intended location), and acceptability (comfort, ease of use, convenience, aesthetic
appeal) [174] . In general, they can be divided as single - use or reusable applicators.
Single - use applicators are usually prefi lled, while reusable applicators are fi lled by
women prior to vaginal insertion. Several applicator designs have been used, such
as barrel - and - plunger and squeeze tube, but they all should be easy to insert, comfortable,
and deprived of cutting edges. Also, some specifi c formulations, such as
those intended for vaginal douching, require other types of applicators. Typically,
squeeze plastic bottles with variable volumes (approximately 100 – 200 mL) are
used.
5.12.5 PHARMACEUTICAL EVALUATION OF VAGINAL DRUG
DELIVERY SYSTEMS
Evaluation of pharmaceutical systems is consensually recognized as an important
component of their development and quality control. Although evaluation of general
features (e.g., drug content) is also required for vaginal formulations, this section
focuses only upon some of the most important parameters that are intimately
related to drug delivery systems specifi cally designed to be administered by this
route.
5.12.5.1 Legal and Offi cial Compendia Requirements
There is a lack of well - defi ned guidelines and regulations for vaginal products in
most countries as well as offi cial compendia information and requirements on
quality control and other important aspects of vaginal drug delivery systems [39] .
In fact, the latest editions of the U.S. Pharmacopeia, European Pharmacopoeia, and
Japanese Pharmacopeia include limited or even no information related to the quality
control and evaluation of vaginal drug delivery systems. Thus, most of the currently
used evaluation procedures require standardization, making it diffi cult to compare
results obtained by different research groups.
5.12.5.2
Drug Release and Permeability
When formulating vaginal drug delivery systems, it is important to consider the
release of the active substances, as different formulations can greatly affect the