Topical use of nitroglycerin for anal fissures by nursing mothers appears to have no adverse effects on their breastfed infants. Topical use on the nipples has been used for alleviation of Raynaud phenomenon of the nipples, but only after cessation of breastfeeding.[1] Nitroglycerin should not be used topically on the nipples during breastfeeding. Sublingual and intravenous nitroglycerin have not been studied during breastfeeding. Observe infants for flushing and discomfort after breastfeeding.

The patch performances and the success of the transdermal drug delivery can be significantly affected by the quality of contact between the patch and the skin. Poor adhesion will dramatically reduce percutaneous delivery. In this study the adhesive properties (peel force and creep resistance) of three monolayer self-adhesive nitroglycerin (NTG) patches available on the market, Deponit, Minitran, and Triniplas, were compared. The patches were characterized also in terms of in vitro drug release and ex vivo skin permeation. The creep resistance values verified in the case of Deponit and Triniplas indicated a low cohesion of these matrices. The peel force values were in the accepted range, even if Triniplas and Deponit showed values double that shown by Minitran. The percentage of NTG released in vitro after two hours in all cases exceeded ninety percent. The ex vivo permeation profiles were similar, even if the three patches had different loaded amounts and surface areas. The measured permeated amount, 11 mg permeated in 24 h, was predictive of the claimed in vivo release (10 mg in 24 h).

A number of transdermal nitroglycerin delivery systems are able to maintain a constant plasma level of nitroglycerin for up to 24 hours, even though the drug's elimination half-life is only a few minutes. Unfortunately, wide variations in plasma drug levels reported in studies of transdermal delivery systems can make plasma level comparisons between products inappropriate and misleading. Other measures of clinical performance include adhesive properties and patient preference. In one adhesion study, Minitran demonstrated superior adhesive properties when compared with Transderm-Nitro, Nitro-Dur II, and a medical reference tape. In patient preference studies involving several hundred patients with angina pectoris, patients consistently selected Minitran over Transderm-Nitro or Nitro-Dur II, citing patch size, shape, ease of application, comfort, better patch adhesion, and reduced instances of skin irritation.

Six men and six women participated in a study designed to compare adhesion-to-skin measurements of three transdermal nitroglycerin patch formulations (Minitran, Transderm-Nitro 5, and Nitro-Dur II) with an occlusive surgical tape control. After 24 hours of wear, Minitran was found to be superior to the other three products in skin adhesion. The force required to remove Minitran was significantly higher than that required to remove the other products. Maintaining good skin contact over the entire application period is essential for consistent drug delivery. Improved skin contact can increase transdermal drug delivery. This increase in delivery of nitroglycerin may result in the development of smaller patches rated to deliver the same quantity of nitroglycerin over a 24-hour period.

Sixty-five patients with angina pectoris participated in a two-week, randomized, crossover, open-label, multicenter trial to compare patient preferences between two transdermal nitroglycerin delivery systems: Minitran and Nitro-Dur II (ND II). Patients were enrolled if they had stable angina pectoris and had been on a stabilized dose (5, 10, or 15 mg/24 hr) of Transderm-Nitro (TDN) for at least one month before entering the study. Patients with a bias against ND II or with any of the contraindications for transdermal nitroglycerin therapy were excluded. During the first one-week treatment period, the patients received their prestudy dose regimen of either Minitran or ND II. During the second week, the patients were crossed over to the transdermal delivery system that they had not received in the first week. Patients completed daily diaries, weekly questionnaires, and poststudy patient preference evaluation forms. Two patients, one in each treatment group, withdrew from the study because of increased angina, which was probably not related to the use of transdermal nitroglycerin. Fifty-seven percent of the patients preferred Minitran overall (P less than or equal to 0.05), 27% preferred ND II, and 16% had no overall preference.

Sixty-three angina patients were recruited to participate in a two-week, randomized, open-label, crossover, multicenter trial to compare patient acceptance of two transdermal nitroglycerin delivery systems, Minitran and Transderm-Nitro (TDN). Patients were enrolled if they had stable angina and had been on a stabilized dose (5, 10, or 15 mg/24 hr) of Nitro-Dur II (ND II) for at least one month before entering the study. Patients with a bias against TDN or with any of the contraindications for transdermal nitroglycerin therapy were excluded. During the two consecutive one-week treatment periods, the patients received their prestudy dose regimen of Minitran and TDN in random order. Patients completed daily diaries, weekly questionnaires, and poststudy patient preference evaluation forms. Of the 63 patients who completed the study, 70% preferred Minitran overall (P less than or equal to 0.001), 24% preferred TDN, and 6% had no overall preference.