Formulation & Characterization of Diclofenac Sodium Loaded Sustained Release Dental Patch For the Management of Orthodontic Pain

Abstract

Introduction: Orthodontic pain occurs due to the forceful movement of the teeth which is characterized due to the displacement of the tooth from its original position which leads to the formation of compression and traction. Pain is associated with adverse outcomes and associated with emotional experiences related to or described in terms of present or impending tissue damage Orthodontic pain is characterized by soreness, tingling sensation, and intolerance in the affected teeth. Almost 70% of orthodontic patients report pain during orthodontic treatment. Furthermore, 25–42% of them have prolonged pain duration. Interestingly, only 15% of patients report pain to be insignificant. When orthodontic stresses are applied to teeth, paradental tissues, such as periodontal tissues and the dental pulp, respond in a predictable way. A series of self-limiting inflammatory processes, including cellular, vascular, neurological, and immunological responses, work together to cause orthodontic discomfort and tooth movement. Prostaglandin and bradykinin, for example, are products of local inflammation that act on sensory endings to cause pain. NSAIDs and local anesthetics are used for the management of orthodontic pain. They are given through oral route due to which they undergo Ist pass metabolism and cause various side effects like gastric bleeding, stomach ulceration, gastritis etc. So, to overcome these side effects the dental patch is formulated to provide the local action. The drug of choice is diclofenac sodium which comes under the pharmacological classification NSAID's- Non-Selective COX 1&2 Inhibitors (acetic acid) (Phenylacetic acid Derivative). Diclofenac possesses analgesic, anti-inflammatory and antipyretic action. It inhibits the enzyme cyclo-oxygenase and there by inhibits the synthesis of Prostaglandins (PGs). Materials and Method: Diclofenac sodium loaded dental patches were prepared by solvent casting method After preparation of dental patch they are further evaluated for various evaluation parameters like pH, thickness, weight uniformity, drug content, fourier transform infrared spectroscopy, in-vitro drug release, ex-vivo permeation, adhesive strength, stability studies. Result and Discussion:The in-vitro characterization of the prepared patches i.e., physical appearance (smooth and uniform), thickness (0.95 ± 0.018 mm), weight uniformity (99.4 ± 0.25 mg), surface pH (6.8 ± 0.08), moisture absorption (1.53 ± 0.57 %), moisture loss (1.73 ± 0.74 %), folding endurance (105.6 ± 3.3),drug content (97.48 ± 1.68 %), and sustained drug release more than 97% in 6 hrs following Korsmeyer Peppas equation showed suitability of formulation for local drug delivery in mouth (gums). Diclofenac sodium being highly permeable (BCS class II) drug showed more than 97 % permeation in 6 hrs through Goat’s gum skin using Franz diffusion assembly. Conclusion: From the above investigation it can be concluded that the dental patch can be potential novel drug dosage form for the treatment of orthodontic pain by increasing the patient compliance and ease of administration and also reduce the frequent administration providing a therapeutic effect for the 6 hours. Hence the diclofenac sodium loaded dental patch were found to be suitable for eliciting better therapeutic effect in the treatment of orthodontic pain.