Development, Characterization, and Clinical Evaluation of a 6% Nitroglycerin-Aloe Vera Transdermal Gel for Stable Angina Management.

The 6% NTG-Aloe vera gel demonstrated desirable physicochemical properties meeting standard formulation criteria.

• The gel was assessed for physicochemical parameters including pH, viscosity, spreadability, and consistency.
• FTIR compatibility testing confirmed no significant drug-excipient interactions.
• Stability testing was conducted under ICH guidelines with no significant degradation observed.
• Dermatological safety was evaluated via skin irritation testing with no dermatological adverse effects reported.

The NTG-Aloe vera gel exhibited sustained zero-order drug release kinetics in vitro.

• Drug release followed zero-order kinetics, indicating a sustained and controlled release profile.
• This release pattern is consistent with the observed gradual and sustained clinical effects.
• The formulation contained 6% nitroglycerin incorporated into an Aloe vera gel base.

The clinical trial enrolled 150 patients with stable angina in a randomized, parallel-group, double-blind design.

• Patients were allocated to receive either 6% NTG-Aloe vera gel or standard sublingual NTG tablets (0.6 mg).
• The trial was registered in Clinical Trial Registry-India (CTRI/2024/11/076947).
• Clinical efficacy was measured using Numeric Pain Rating Scale (NPRS), chest tightness scores, Seattle Angina Questionnaire (SAQ), blood pressure, and oxygen saturation.

The NTG-Aloe vera gel produced superior Seattle Angina Questionnaire scores compared to sublingual NTG.

• SAQ scores were significantly better in the gel group compared to the sublingual NTG group (p<0.001).
• The gel provided gradual, sustained pain relief as measured by NPRS.
• Chest tightness scores also showed improvement with the gel formulation.

The NTG-Aloe vera gel induced a controlled hypotensive response without abrupt cardiovascular changes.

• Vital parameters including blood pressure and oxygen saturation were monitored clinically.
• The gel produced a controlled hypotensive response, in contrast to the more abrupt cardiovascular effects associated with sublingual NTG.
• This controlled hemodynamic profile was interpreted as indicating enhanced safety.
• Improved tolerability was observed compared to sublingual NTG.

No dermatological adverse effects were reported with the transdermal NTG-Aloe vera gel.

• Skin irritation testing was performed as part of dermatological safety evaluation.
• No adverse dermatological reactions were observed in any patient receiving the gel formulation.
• The absence of skin adverse effects supports the tolerability profile of the Aloe vera-based gel.