Rui Li et al. registered a mixture of indole alkaloids from the leaf of A. scholaris
as an investigational new botanical drug (No. 2011L01436) for the treatment of
various respiratory-related ailments and was approved for phase I/II clinical trials
by CFDA (Li et al. 2019). A randomized, open-labeled, clinical trial was performed
in healthy Chinese volunteers (40) for evaluating the safety and pharmacokinetics
of capsule of alkaloids from the leaf of A. scholaris (CALAS) at different doses (20,
40, 80, 120 mg per oral). 24, 75, 30, and 20 are the major compounds reported for
the desired pharmacological activities (respiratory diseases). A dose depended
effect were observed in C max , AUC 0-t , and AUC 0-∞ . Among the alkaloids, 30 was
detected at higher concentration in blood (C max : 12.909–60.889 ng/ml), followed
by 24 (C max : 2.162–21.025 ng/ml), 19-epischoalricine (C max : 1.172–9.391 ng/ml)
and least by 20 (C max : 1.295–8.674 ng/ml). Further, 30 and 20 had a half-life up to
3–4 h, while 24 and 75 were up to 10 h. 24 exhibited a non-linear nature in a
multi-dose linear relationship, while the remaining alkaloids exhibited a linear
characteristic. CALAS was safe and well-tolerated without any serious adverse
events during the whole trial periods. From these promised results, it can be
deduced that 40–80 mg/time t.i.d capsule is required per day to maintain an
effective blood concentration, and the effectiveness of these results has to be confirmed by performing further the phase II clinical trials by using these dosage
regiments.
14.5 Intellectual Property Rights (IPR) Values of Alstonia
Genus
IPR refers to the general term for the assignment of property rights by an intergovernmental organization in forms of patents, copyrights, and trademarks. These
property rights provide an exclusive right to an inventor or assignee to exercise a
monopoly on the use of the item for a specified period. Many commercial and
academic institutions protect their research information through IPR which makes
these as early sources of cutting-edge research. A huge number (>300) of patents
has been filed that comes under the Alstonia genus. However, the majority of these
patents come with Alstonia as a single component in polyherbal formulations.
These kinds of patents are beyond the scope of this book chapter; hence they were
excluded. In the present chapter, Table 14.14 indicates various patents with
Alstonia as one of the major components. The majority of the patents have to
explore the traditional knowledge of Alstonia genus-related activities. For instance,
a higher number of patents can be observed with respiratory-related ailments and
skin-related problems. Apart from that various formulations were also patented.
524
A. T. Paul et al.
as an investigational new botanical drug (No. 2011L01436) for the treatment of
various respiratory-related ailments and was approved for phase I/II clinical trials
by CFDA (Li et al. 2019). A randomized, open-labeled, clinical trial was performed
in healthy Chinese volunteers (40) for evaluating the safety and pharmacokinetics
of capsule of alkaloids from the leaf of A. scholaris (CALAS) at different doses (20,
40, 80, 120 mg per oral). 24, 75, 30, and 20 are the major compounds reported for
the desired pharmacological activities (respiratory diseases). A dose depended
effect were observed in C max , AUC 0-t , and AUC 0-∞ . Among the alkaloids, 30 was
detected at higher concentration in blood (C max : 12.909–60.889 ng/ml), followed
by 24 (C max : 2.162–21.025 ng/ml), 19-epischoalricine (C max : 1.172–9.391 ng/ml)
and least by 20 (C max : 1.295–8.674 ng/ml). Further, 30 and 20 had a half-life up to
3–4 h, while 24 and 75 were up to 10 h. 24 exhibited a non-linear nature in a
multi-dose linear relationship, while the remaining alkaloids exhibited a linear
characteristic. CALAS was safe and well-tolerated without any serious adverse
events during the whole trial periods. From these promised results, it can be
deduced that 40–80 mg/time t.i.d capsule is required per day to maintain an
effective blood concentration, and the effectiveness of these results has to be confirmed by performing further the phase II clinical trials by using these dosage
regiments.
14.5 Intellectual Property Rights (IPR) Values of Alstonia
Genus
IPR refers to the general term for the assignment of property rights by an intergovernmental organization in forms of patents, copyrights, and trademarks. These
property rights provide an exclusive right to an inventor or assignee to exercise a
monopoly on the use of the item for a specified period. Many commercial and
academic institutions protect their research information through IPR which makes
these as early sources of cutting-edge research. A huge number (>300) of patents
has been filed that comes under the Alstonia genus. However, the majority of these
patents come with Alstonia as a single component in polyherbal formulations.
These kinds of patents are beyond the scope of this book chapter; hence they were
excluded. In the present chapter, Table 14.14 indicates various patents with
Alstonia as one of the major components. The majority of the patents have to
explore the traditional knowledge of Alstonia genus-related activities. For instance,
a higher number of patents can be observed with respiratory-related ailments and
skin-related problems. Apart from that various formulations were also patented.
524
A. T. Paul et al.