Storage and Packaging of Active Pharmaceutical Ingredients and Biopharmaceuticals containing Procipient®(Dimethyl Sulfoxide USP, PhEur)

The choice of an appropriate container when packaging pharmaceutical dosage forms is very important. You must first understand which materials are compatible with your application. Glass containers are the most common form of packaging for pharmaceuticals. These are intended for direct contact with pharmaceutical products. Commonly used glass is either composed of Borosilicate Glass or Soda-Lime Glass. Per USP[i], there are three types of glass: Type I (Borosilicate), Type II (Soda-Lime with hydrolytic resistance) and Type III (Soda-Lime Silica).

Most packaging manufacturers hold a US-FDA Drug Master File (DMF) type III Packaging Material. This is very helpful when filing your final product with the FDA.

Another factor to keep in mind when selecting packaging containers for pharmaceuticals are handling considerations. Tubular vials withstand thermal shock better than molded glass containers[ii].

[i] USP: United Stated Pharmacopeia General Chapter <1660> ; EP (3.2.1)

[ii] Wheaton Containers Guide (https://wheaton.com/media/catalogs/Containers%20Guide/files/assests/basic-html/page19.html); Schott Glass (www.us.schott.com); Gerresheimer (www.gerresheimer.com)

Table 1

Compliant Glass Containers for Formulations Containing Procipient

Manufacturer[i]	Type	Compliance
Gerresheimer	Tubular Type I/II/III	USP, PhEur, JP, FEUM
Schott Glass	Tubular Type I	USP, PhEur
Duran GroupDURAN^® PURE	Type I	USP, PhEur, JP
Wheaton	Tubular & Molded Type I	USP

[i] Gerresheimer (www.gerresheimer.com); Schott Glass (www.us.schott.com); Wheaton, DWK Life Sciences (www.wheaton.com)

Gaylord recommends the usage of tubular vials for finished pharmaceuticals containing Procipient. Table 1 shows commercially available vials which are compatible with Procipient. Always remember that every formulation is different. We advise the use of accelerated stability testing to demonstrate compatibility between packaging material and your product.

The usage of USP Type I Borosilicate Glass containers for packaging parental and non-parental products is suggested[i]. This type of glass is ideal for injectables[ii], in solution or powder, and can be sterilized. Ampoules, vials and syringes for injectable/powder solutions are available in USP Type I glass. Bottles should be used for powdered drug substances.

As referenced in USP <660>, If protection against pH shifting and alkali extraction is needed, Type II glass should be used. The use of Type II glass is recommended if the preparation remains below pH 7 during its shelf life[iii]. Molded Glass containers are usually USP Type II and Type III Glass.

For storage of bulk drug intermediates, transport of APIs and manufacturing of pharmaceutical products we recommend DURAN^® PURE (referenced in table 1).

For storage and clinical applications, the use of USP Type II or Type III containers is recommended. If your formulation is in a liquid or serum form, a Type II vial may work for you. In the case the formulation is in a lyophilized form, a Type III container would be useful. Again, always confirm material compatibility prior to selection of packaging material.

An alternative to glass which is compatible with Procipient is High Density Polyethylene (HDPE). Table 2 provides an example of HDPE Bottles that may be used to store formulations.

[i] USP <1660>

[ii] BIOMED (http://biomed.co.th/)

[iii] Wheaton Containers Guide (www.wheaton.com)

Table 2

HDPE Bottles for Pharmaceuticals and Biologics Formulations using Procipient

Manufacturer[i]	Supplier	Application	Packaging	Part No.	Volumes available	Compliance
Fisherbrand™	Fisher Scientific	Transport and Storage	Non-Sterile	03-007	60 – 500 mL	USP
Nalgene™	ThermoFisher	Transport and long-term Storage	Non-Sterile	2106	30 – 500 mL	USP
Thermo Scientific™ Nalgene™ HDPE Biotainer™	Fisher Scientific	Transport and Storage Biologics	Sterile	375024	4 L	USP Class VI, Non-cytotoxic, USP <661>, Non-pyrogenic, FDA 21CFR 177.1520

[i] Fisher Scientific; ThermoFisher Scientific

Selecting the appropriate closure system is another important aspect of the packaging selection process. In Gaylord Chemical’s experience, the usage of a polypropylene closure with virgin PTFE Teflon is the appropriate choice of a closure system for formulations involving DMSO. For bottles with screw cap closures, choose a style that has a continuous thread closure, fined ribbed shell, retention ring and a friction fit liner. The liner should not be glued to into the cap body. For vials, Teflon lined stoppers and crimp/serum finish types would be compatible with DMSO.

For more information please contact Gaylord Chemical Company or visit our website at gaylordchemical.com

References

[1] USP: United Stated Pharmacopeia General Chapter <1660> ; EP (3.2.1)

[1] Wheaton Containers Guide ; Schott Glass; Gerresheimer

[1] Gerresheimer; Schott Glass; Wheaton, DWK Life Sciences

[1] USP <1660>

[1] BIOMED

[1] Wheaton Containers Guide

[1] Fisher Scientific; ThermoFisher Scientific