Nonsterile Basics of Compounding: Using U.S. Food and Drug Administration-approved Commercial Products as Ingredients.

Throughout history, pharmacists have used natural products, chemicals, and other materials for prescription compounding. In the past, these chemicals and materials were obtained from natural preparations, raw materials, and even household ingredients. Today, compounding pharmacists use chemicals from various legitimate sources, depending on availability and may even use manufactured drug products as the drug source for compounding (this is especially true in hospital intravenous admixture programs).

Sterile Basics of Compounding: Allowable Endotoxin Levels in Parenteral Preparations.

Inadvertent administration of endotoxins to humans may result in a number of events, ranging from fever, through a cascade of pathogenic responses, to death. Endotoxins are potent, toxic, and very stable and are present in many pharmaceutical ingredients and on surfaces that come into contact with preparations formulated for parenteral administration. Endotoxins are very difficult to eliminate in a final preparation, therefore, procedures are generally directed at eliminating endotoxins during the preparation process. This article discusses the allowable endotoxin levels in parenteral preparations.

Excipients and Adverse Events.

Pharmaceutical excipients are substances formulated with an active ingredient in a medication. This article has provided a brief discussion on excipients, the purpose of excipients, the selection of appropriate excipients, the use of excipients in formulation development by compounding pharmacists/manufacturers, excipient examples and usage, the numerous incompatibilities that should be considered when choosing an excipient, and a list of adverse effects related to excipients.

Basics of Sterile Compounding: Sterile Basics of Compounding Intravenous Admixtures, Part 4: Physicochemical Considerations.

Intravenous admixture compounding is common practice in most hospitals throughout the world, regardless of the country. Compounding intravenous medications involves risk, as there is a high potential for error due to their complexity in compounding as well as the additional issues that working in an aseptic compounding environment poses for the compounder. This article in a series of intravenous admixture compounding discusses considerations involved when using commercial products in compounding, as well as a discussion on the issues of freezing, solubility, sorption, leaching, incompatibilities, and quality control, with an emphasis on physicochemical considerations.

Basics of Compounding: Compounding Foams.

Pharmaceutical foams are gaining in popularity. The use of foam technology now delivers a range of topical active agents, including corticosteroids, other anti-inflammatories, sunscreen compounds, and antibacterial, antifungal, and antiviral agents. In addition to the distinct application advantages and improved patient compliance with foams, a real reason for the rapid growth of topical foam technology is that foams are elegant and aesthetically and cosmetically appealing products that provide an alternative to ointments, creams, lotions, and gels in the highly competitive dermatological market. In addition to all this, foams can be easily compounded for patients to take advantage of the uniqueness and applicability of this dosage form in medication administration. As an example, for the treatment of inflamed skin conditions such as sunburn and eczema, topical foams are preferred because they can be spread more easily and thereby minimize the amount of rubbing required to distribute the formulations. Another innovative use of forms is in administering a liquid medication to a bedridden patient. When a liquid is placed in a spoon or measuring device, it may spill. However, if the foam is placed in the spoon, it can be delivered to the patient without spilling. Properly formulated, this foam can be spill resistant, reproducible, easily flavored and taste masked, and pediatric and geriatric friendly.

Sterile Basics of Compounding: Intravenous Admixture Compounding, Part 3: Preparation Procedures.

Intravenous admixture compounding is common practice in most hospitals throughout the world, regardless of the country. Compounding intravenous medications medications involves risk as there is a high potential for error due to their complexity in compounding, and working in an aseptic environment itself poses issues for the compounder. Part 1 of this series presented an introduction and an overview of the series; part 2 presented parenteral vehicle considerations and examples; and part 3 discusses preparation procedures as well as discussions on standardization (both formulas and procedures), competency, compliance issues, issues with using commercial product additives, and look-alike drugs.

Nonsterile Basics of Compounding: Compounding with Antioxidants, Part 1: An Overview.

This article, which is part 1 of a series on compounding with antioxidants, discusses specific preparation methods and techniques along with packaging, storing, and labeling issues. Also presented are the allowable overages from the United States Pharmacopeia's discussion on "Commercial Parenteral Products". Some considerations related to potential issues when compounding with commercial products are also discussed using specific examples. The article ends with a discussion of product standardization and look-alike products. The formulation of an antioxidant system is accomplished primarily through trial and error. With some experimentation and patience, a suitable, stable system with the required characteristics can be obtained.

Nonsterile Basics of Compounding: Compounding with Humectants.

Humectants are in common use not only in pharmaceuticals but also in foods, cosmetics, etc. The proper selection of a humectant in a pharmaceutical formula depends upon the dosage form, ingredients, physical and chemical characteristics, as well as stability issues. Some of the more typical examples of humectants that are used in pharmaceuticals, foods, and cosmetics are provided in this article, as well as a more detailed list of humectants used in pharmaceuticals, including some physicochemical characteristics.

Sterile Basics: Intravenous Admixture Compounding, Part 2: Parenteral Vehicle Considerations.

Intravenous admixture compounding is a common practice in most hospitals throughout the world, regardless of the country. The compounding of intravenous medications, however, involves risk, as there is a high potential for error due to their complexity in compounding. Also, working in an aseptic environment itself poses issues for the compounder. This article in an overall series on the topic of intravenous admixture compounding will discuss the vehicles commonly used in intravenous admixtures, as well as the small-volume parenterals often used in compounding intravenous admixtures.

Sterile Basics: Intravenous Admixture Compounding, Part 1: Introduction and Overview of the General Guidelines for an Intravenous Admixture Compounding Program, and Compounding Personnel Considerations.

Intravenous admixture compounding is a common practice in most hospitals throughout the world, regardless of the country. Due to the complexity in compounding intravenous medications, there is a high potential for error, and since intravenous medications must be compounded in an aseptic environment, this poses additional issues for the compounder. Part 1 of this series of articles provides an introduction, an overview, and compounding personnel considerations of this topic. The remaining parts of this series will cover parenteral vehicle considerations; preparation procedures; physicochemical considerations; handling potential incompatibilities; endotoxin considerations; and quality control of intravenous admixtures. This introductory article in this overall series on intravenous admixture preparation presents issues related to their compounding and to medication error prevention.

Advanced Compounding: Compounding with Microneedle Arrays, Part 3: Microneedle Array Development in the Literature and Quality Control of Microneedle Arrays.

Microneedle arrays, or microneedle array patches (terms are often used interchangeably), are promising devices for the transdermal delivery of drugs and vaccines. Unique microneedle arrays can be prepared from various materials and can be either solid or hollow. Upon insertion, they rapidly take up skin interstitial fluid to form continuous, open conduits from the attached patch-type drug reservoirs to the dermal microcirculation. Microneedle array patches can be prepared using molds in a wide range of patch sizes and microneedle geometries, can be easily sterilized, resist hole closure while in place, and are removed completely intact from the skin. Delivery of macromolecules is no longer limited to what can be loaded into the microneedles themselves, as they can also be loaded as a reservoir and delivered through the microneedles. Also, transdermal drug delivery can now be controlled by the cross-linked density of the hydrogel matrix rather than the stratum corneum. This newer technology has the potential to overcome limitations of conventional microneedle designs and to greatly increase the range of the type of drug that is deliverable transdermally, which benefits industry, healthcare providers, and, ultimately, patients.

Compounding with Biotechnology Products, Part 2: Product-specific Considerations.

Biotechnology drugs involve any technique that uses living organisms in their production or modification. These biotechnology drugs are prepared using different techniques such as recombinant DNA technology monoclonal antibody technologies along with tissue cultures living cells and cell enzymes to make specific products. These new pharmaceuticals are utilized in the diagnosis treatment and prevention of disease, but, because of the risk of clinically important and unusual and potentially harmful adverse effects produced, these agents require increased safety surveillance, and it is very important for pharmacists to participate in any adverse event reporting and monitoring program for these new products. The first biotechnology pharmaceuticals are proteins, but, eventually, an ever-increasing number of smaller molecules may be discovered through the previously mentioned methods and may become a mainstay in new pharmaceutical research and development in producing new drug products. Pharmacists involved in compounding must be aware of not only the biotechnology agent itself but especially of all of the different excipients that are required in order to produce a stable and safe preparation for patient use. Compounding involving these formulations should involve the simplest procedures and formulations as possible, maintaining sterility throughout the entire process. It is important to maintain a drug's biologic activity up to the point of administration to the patient, and the pharmacist can assist in explaining the various factors involved in storage preparation and administration of the drugs to the patient. In the first part of this two-part series of articles, we discussed the general considerations involved in compounding with biotechnology products. In this final part of the series, we discuss the formulations for a number of commercially available biotechnology products, the purpose of each of the ingredients, and any uniqueness about their formulations.