Formulation and Evaluation of an Iranian Traditional Dosage Form Containing Linum and Ficus for Improvement of Functional Constipation

[Background]Constipation is a common gastrointestinal problem worldwide.[Objectives]The current study aimed to prepare a dosage form containing flaxseed and figs and evaluate the effects of this drug to treat functional constipation.[Methods]A total of 10 formulations were developed using various proportions of excipients by wet granulation method. The best formulation containing 300 mg flaxseed powder and 1200 mg figs extract (total weight of 2000 mg) was selected. After compression of caplets, evaluation tests such as general appearance, hardness, thickness, weight variation, friability, disintegration time and standardization studies were performed. During clinical study, 15 patients with functional constipation received the prepared dosage form three times daily for two weeks, and then statistical differences within the groups were compared.[Results]After the first week of experiment the increase of defecation frequency and reduction of retentive posturing, large fecal mass, pain feeling during evacuation and consistency of stool were significantly noticeable (P < 0.05).[Conclusions]Prepared caplets of Linum and Ficus reduced the severity of constipation in patients.